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    Skills Alliance has been exclusively retained by a clinical-stage biotechnology company to hire a Senior Director, Medical Affairs to provide medical leadership and expertise to their neurology therapeutic area.

    This fast growing, NASDAQ-listed company has an innovative and active research pipeline focused on enzyme therapies in pre-clinical and clinical stage for ultra-rare and oncologic diseases, with a strong commitment to the neuromuscular space. Global Phase III trials are currently underway for their lead asset with an intended global launch in 2021.

    Reporting to the VP Global Medical Affairs, the company is hiring a Senior Director to lead the medical affairs activities of the USA, with full responsibility for designing and executing the in-country medical launch strategy and bringing an ultra-orphan drug to market.

    Job Responsibilities:

    • Lead the development and implementation of the Medical Affairs strategy, plan and activities within the neurology therapeutic area, aligning with cross-functional colleagues
    • Develop and continuously maintain the highest scientific and medical expertise with all diseases and products within the neurology therapeutic area and be acknowledged internally and externally as an expert
    • Drive the identification and development of productive collaborations with clinical experts, other important customers and stakeholders, including professional organizations
    • Initiate and support high impact medical activities, such as advisory boards, congress symposia, hospital meetings, speaker development programs and reimbursement agency education
    • Identify and implement appropriate high-impact medical research projects to support the business objectives, including company sponsored and investigator-initiated projects
    • Coordinate the implementation of medical affairs practices, and systematic information gathering to assess new indications, the treating community, patient pathways, diagnostic practices and management strategies in relevant disease areas
    • In conjunction with clinical development and operations support clinical study development, feasibility assessment, initiation and ongoing management to achieve recruitment and study objectives
    • Coordinate the identification of patients in relevant diseases for inclusion in future clinical research projects and disease registries
    • Provide medical leadership to expanded access programs and managing requests for company product supply (e.g. compassionate use requests)
    • Actively engage with all relevant cross-functional teams including science, clinical development and operations, commercial and market access, providing medical leadership to development, pre-launch, launch and post-launch strategy
    • Attend appropriate national and international meetings and congresses to gather intelligence, assist personal education, ensuring to utilize these opportunities to develop relationships with important customers
    • Conduct and provide medical leadership to training programs to field-based teams and other functions and prepare staff to handle interactions with customers
    • Ensure medical accuracy of Medical Affairs activities, including advisory boards and scientific expert meetings, studies, publications, scientific congress activities, medical education, medical information content and medical field programs
    • Ensure all medical affairs activities maintain the highest standards, comply with applicable pharmaceutical regulation, as well as company policies and procedures

    Qualifications:

    • Advanced scientific degree (PhD, PharmD, MD)
    • Previous industry experience in leading pre-launch medical affairs activities at in-country or above-country level
    • Therapeutic experience in neurology / CNS / Neuromuscular / Autoimmune / Orphan disease areas
    • Clinical practice experience in neurology preferred
    • Excellent rapport building and interpersonal skills
    • Strong command of the English language
    • An entrepreneurial mindset, dynamic attitude and desire to work in a hands-on role
    • Willingness for up to 40% travel time

    The role will involve paving the way for pioneering science with great autonomy and accountability for the medical strategy and execution within the neurology business unit.

    Skills Alliance is exclusively partnered with this innovative biotech. Please click APPLY or call Karina Sharipova at +44 (0) 207 220 6205 to receive further information, including a full job description.

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    Title: Research Associate/Senior Research Associate

    Location: Seattle, WA

    We are currently working alongside a groundbreaking T-Cell Immunotherapy company, who are looking to bring the power of cell-based immunotherapies to help patients around the world. First and Foremost focusing on the science, their unique and disruptive approach sets them apart from the rest.

    They are currently looking for a Research Associate OR Senior Research Associate to join their Cell Pipeline Development team. This role will help with the hands-on development of their next generation cell therapies for treating cancer. The ideal candidates will be familiar with a wide range of immunological assays, willing to think outside the box in the design of new assays relevant to each project and be motivated to apply unique science-based concepts into new cellular products.

    Qualifications

    • B.Sc. and 3-5 years of experience immunology, immuno-oncology or a related field in an industry setting
    • Expertise with use of common immunology assays such as cytokine determinations, cellular proliferation, CTL assays, ELISAs, flow cytometry, etc.
    • Expertise in basic assays related to evaluation of RNA and protein expression (QPCR, westerns, etc.)
    • Preferred prior experience working with human samples, specifically primary T cell culture
    • Preferred familiarity with animal models for safety and immunotherapy studies, ideally in cell therapies

    We are moving very quickly with this role, so please don’t hesitate to apply as soon as possible!

  • USA

    Competitive Hourly Rate
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    Title: Senior Buyer

    Location: Seattle, WA

    We are currently partnered with a local Seattle research and diagnostic biotechnology company who are looking for a Senior Buyer to join their growing team!

    Unlike many others in the area, this company not only focuses on the research and science, but also on the diagnostic tools needed to enable the research they are doing in translational medicine and in vitro diagnostics. This is a great opportunity for candidates who are looking to work cross-functionally and gain the experience necessary to grow their career!

    • Procure materials, supplies, capital equipment, and services for all NanoString functional areas.
    • Collaborate with cross-functional teams to assure materials are received to specification, on-time, and at the lowest possible cost
    • Manage over-shipments, delivery shortages, changes in specifications, quantities, delivery dates, and prices as well as report such changes to the interested parties in a timely manner as required
    • 5-7 years of buyer planner experience
    • ERP system knowledge– preferably Microsoft Dynamics

    This role will start as a contract position, with the opportunity to become FTE within 6 months.

    We are moving very quickly with this role, so please don’t hesitate to apply as soon as possible!

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    Our client, a leading pharmaceutical company are looking for a Clinical Research Physician with expertise in immunology to drive the clinical development plan. The company specializes in the field of cardiology and is developing three innovative compounds. They specialise their work within the immunology area and have already received very promising results for two of their leading drugs that are currently in phase I and II of clinical development. The individual will play a key role at Health Authority meetings, including FDA and EMA meetings, and drive the growth of the company on the international scheme. The position is based in Paris but offers flexibility.

    The Role

    You will be responsible for all clinical development activities with the support of your team operating on the international level. 4 direct reports are included with plans to continue to grow the team after receiving very positive clinical development results. The person will provide their expertise in clinical development in the development of their phase II clinical trials in Europe and around the world.

    Responsibilities:

    • Creating the clinical development plan
    • Managing the relationships with external stakeholders, such as Opinion Leaders and CROs
    • Managing a team of 4 people
    • Conducting key meetings with the healthcare authorities in the US and Europe
    • Organizing crucial meetings with the investors

    Requirements:

    • Medical degree (Board Certification in immunology is highly desirable)
    • Experience in oncology gained during time within the industry
    • 6+ years management experience within industry
    • Fluent in English (required)

    Apply:

    Apply here if you are interested in this opportunity or if you would like a confidential discussion about this career opportunity please contact Anastasia Ioannidi

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    Director of Quality Assurance

    Our client, a large Pharmaceutical company, are looking for a Director of Quality Assurance to establish and improve the current ways of working within the QA department. They are looking to expand the Quality team rapidly to keep up with the multiple projects they are planning in the near future and are currently working on.

    The Role

    The role requires a very experienced leader in the Quality Assurance market, and ideally qualified as a QP. This role comes with a lot of responsibility, as the candidate will be in charge of a department of around 25 people, with 4 managers/team leaders.

    Requirements:

    – 15 years experience working in QA, with at least 5 of those in a position with responsibility for managing managers.

    – Qualified Person.

    – Experienced Auditor.

    – GMP/GDP expertise.

    – Ability to drive change and act as a strong leader.

    – Fluent in English and Swedish.

    – Excellent communication skills.

    Apply:

    Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact: matthew.t.a4lgdx1gt141@skillsalliance.aptrack.co or +44 (0) 20 7220 6200

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    Clinical Trial Supply Manager

    An exciting biopharmaceutical company are looking for a Clinical Trial Supply Manager to join their dynamic and vastly growing team. Thanks to extensive investment to their Development departments they have multiple products within their portfolio. They specialise their work within the Oncology area and have already received very promising results for their ground-breaking medicines along with multiple other products and indications. The individual will play a leading role helping drive growth company development. The position is based in Lausanne and offers some home-based working.

    The Role

    You will be managing the delivery of the Investigational Medicinal Products (IMP) including Comparators / Standards of Care according to the study protocol and the project plan in terms of quantity and quality of product and timelines. The position is a 1 year assignment in the first instance.

    Responsibilities:

    • Build a proposal for clinical trials supply in terms of quality and regulatory, packaging design, etc
      • Work closely with the Contract Manufacturing Organisation (CMO) to manage the operational activities
      • Set up the labelling, packaging, storage and management of the IMP
      • Collaborate extensively with the Clinical Operations team including the sponsor, Qualified Person, etc
      • Ensure key documentation is available and accurate via the e-TMF

    Requirements:

    • · 2+ years Clinical Trial Supplies experience
    • · Phase I – III international clinical studies experience
    • · Project management experience
    • · Good understanding of GMP requirements for IMP supply
    • · Fluent in English

    Apply:

    Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities

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    We are currently partnered with a leading pharmaceutical company in the Orphan disease space, who are looking to bring on a new Director for Clinical Development. This position falls within their senior executive team and therefore has a lot of responsibility and input on the future direction of their R&D strategy. They have a wide range of indictions within rare diseases, with their leading products currnetly moving through phase II of development. The position will be based in Switzerland.

    The Role

    You will lead all clinical development activities across Europe and look to advance their current dvelopment program by working closely with the CMO.

    Recquirments

    • Orphan Drug Designation experience preferred
    • Advanced knowledge of assigned therapeutic area
    • Experience of clinical development in EU and USA preferred
    • 10+ years experience working with rare/orphan diseases

    Apply here if you are interested in this opportunity or if you would like a confidential discussion please contact Matt Jamison

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    Skills Alliance has partnered exclusively with a transformative global biotechnology company focused on bringing gene therapies to patients with rare diseases to build their Project Leadership team. We are hiring 4 Senior Project Management Leaders, each responsible for leading their respective global development team. It is a highly visible and influential role within the organisation, ultimately responsible for the successful progression of assets through development and commercialisation; it is accountable to the Executive Leadership team.

    The position is office-based in the Greater London area and we will consider international commuting and relocation.

    Job Responsibilities:

    • Provide leadership to the global development team in ongoing projects, ensuring they are delivered on time and on budget
    • Facilitate an open and collaborative environment that inspires high performance and is in line with the company’s core values
    • Work closely with functional heads to create and implement project strategies
    • Set proactive and realistic timelines to reach objectives, ensuring the alignment of development plans across CMC, Commercial and R&D
    • Ensure efficient project implementation by holding people accountable to decisions made
    • Ability to resolve conflicts in an objective and influential manner
    • Chair cross-functional team meetings, create and execute appropriate action plans and report progress back to the Executive Leadership Team
    • Enable technical data to be reviewed at team meetings and ensure appropriate actions are made to validate the technical integrity of the program plans, with appropriate follow-up actions
    • Run team development workshops and work with HR to ensure the development of team members and provide performance feedback
    • Act as a spokesperson for the project/program internally and externally

    Qualifications:

    • Advanced degree preferred
    • Extensive project management experience in rare diseases (advanced therapy area experience preferred)
    • Knowledge of the drug development process, particularly phase II and III (additional knowledge of the commercialisation process is preferred)
    • Command of the English language

    The company is particularly attracted by engaging and science-driven individuals inspired by their vision of finding long-term solutions for those suffering from genetic conditions. Skills Alliance is exclusively partnered with this innovative company.

    Please click APPLY or contact Oliver Drew on+44 (0) 203 862 9603 to receive further information and arrange a confidential discussion.

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    Our client is very exciting and growing pharmaceutical company, that develops treatment for oncology patients. For their branch in Germany we are currently looking for a Medical Science Liaison, who will be responsible for Northwest region. This a fantastic opportunity for an experienced scientist in oncology area to work within very dynamic and innovative environment.

    Job Responsibilities:

    • Cooperation with specialists and opinion leaders in the field of oncology
    • Building new relationships with regional and national stakeholders
    • Close cooperation with in-house departments regarding site strategy and identification of clinical topics and research opportunities
    • Ensuring the exchange of up-to-date scientific information between internal and external partners and the initiation of scientific programs, studies, symposia and seminars
    • Participation in medical and scientific conferences at home and abroad
    • Close cooperation with the MSL team in other European countries
    • Support of product launch activities and developments as well as the implementation of regional launch strategies
    • Organizing and participating in product and medical training for healthcare professionals through on-site clinical activities, in external centers, professional societies and at conferences

    Candidate’s Requirements:

    • Doctorate in the field of science, medicine or pharmacy required
    • Research experience in the field of solid tumors or neuro-oncology much desired
    • Experience in planning and initiating projects advantageous
    • Excellent communication and negotiation skills
    • Fluent German and English spoken and written
    • Willingness to travel extensively and a high degree of flexibility

    For more information please contact Maja Vidovic @ 0041 22 518 82 49

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    Skills Alliance is collaborating with a global engineering consultancy based in Basel that serves clients within the (bio)pharmaceutical and medical device industries. On our client’s behalf, we’re currently recruiting for a Process Validation Engineer to start an open-ended project at a biopharmaceutical manufacturing site in Bern, Switzerland.

    Responsibilities

    • Plan, Coordinate and execute all phases for validation of processes and supporting validation activities (i.e. cleaning validation, cleaning verification, mixing validation etc.)
    • Prepare and review (validation plans, minutes, reports) GMP related documentation
    • Bridging with cross-functional teams handling validation activities
    • Operational handling of Change Controls, CAPAs and Non-Conformances related to process validation and supporting validation activities
    • Perform risk/criticality assessments

    Requirements

    • Bachelor/Master Degree in technical or natural sciences
    • A minimum of 3 years of working experience within pharma or a biotech company
    • Basic Know-how of biotechnology processes
    • Profound Know-how of Validation requirements according to cGMP
    • Experience in process validation is a must
    • Experience in cleaning validation is an asset
    • Know-how of quality assurance principles
    • If you would like to have more info

    Our client provides all their project engineers with a competitive basic salary, travel compensation and overtime pay. If you would like to know more about this position, please get in touch with Khephren Mongongu +41 43 508 29 16 or click apply. We’re looking forward to your application.

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    Skills Alliance is collaborating with a global engineering consultancy based in Basel that serves clients within the (bio)pharmaceutical and medical device industries. On our client’s behalf, we’re currently recruiting for a Qualification Engineer to start an open-ended project at a biopharmaceutical manufacturing site in Luzern, Switzerland.

    Responsibilities

    • Plan, Coordinate and execute all phases qualification activities (IQ, OQ, PQ)
    • Prepare and review (qualification plans, minutes, reports) GMP related
    • documentation
    • Equipment qualification (small size equipment, clean rooms, HVAC)
    • Operational handling of Change Controls, CAPAs
    • Perform risk/criticality assessments

    Requirements

    • Bachelor/Master Degree in technical or natural sciences
    • A minimum of 3 years of working experience within pharma or a biotech company
    • Profound Know-how of Validation requirements according to cGMP
    • Experience in small size equipment qualification, clean rooms and HVAC
    • Fluent English & German

    Our client provides all their project engineers with a competitive basic salary, travel compensation and overtime pay. If you would like to know more about this position, please get in touch with Khephren Mongongu +41 43 508 29 16 or click apply. We’re looking forward to your application.

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    We are working with a local biotech who is on the cutting edge of cell-based immunotherapies! In the CAR T and solid tumor space, they are utilizing a disruptive approach to research and development and fostering a very collaborative learning culture. This company is making strides towards a cure for cancer.


    They are currently looking for a Research Associate for their Cell Engineering team. This is a great opportunity for anyone looking to expand their career and be in a startup environment.


    Required Experience:

    • At least 1-2 years of research experience in either industry or a relevant academic environment
    • Ability to culture and maintain mammalian cell lines
    • Familiarity with basic molecular biology techniques and lab practices
    • Flow cytometry and cell sorting
    • Experience working with Jurkat cell lines and primary human T cells
    • Experience with Electronic Lab Notebooks (ELNs) and experimental record-keeping in an industry setting

    Preferred Additional Skills:

    • Molecular cloning
    • Lab automation
    • General understanding of immunology and oncology

    We are moving quickly on this role, so please don’t hesitate to apply!

  • USA

    Competitive Pay + Benefits
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    We are working with a local biotech who is on the cutting edge of cell-based immunotherapies! In the CAR T and solid tumor space, they are utilizing a disruptive approach to research and development and fostering a very collaborative learning culture. This company is making strides towards a cure for cancer.


    They are currently looking for a Research Associate for their Gene Delivery team. This is a great opportunity for anyone looking to expand their career and be in a startup environment.

    Experience:

    • viral vector and non-viral delivery methods, gene editing technologies, cell engineering, and cell line generation is preferred
    • Understanding of the biology around DNA sensing in primary human cells
    • Experience with multi-color flow cytometry and cell sorting for construct testing

    Preferred Additional Skills:

    • Expertise with use of common immunology assays such as cytokine determinations, cellular proliferation, cytotoxicity assays, ELISAs and flow cytometry
    • Knowledge of the biology related to DNA sensing pathways a plus
    • Expertise with pertinent analysis software (Prism, Flow Jo, Spotfire, Genious, etc)
    • Prior experience working with human samples, specifically primary T cell culture
    • Experience with Electronic Lab Notebook (ELN) systems

    We are moving quickly on this role, so please don’t hesitate to apply!

  • USA

    Competitive Pay + Benefits
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    We are working with a local biotech who is on the cutting edge of cell-based immunotherapies! In the CAR T and solid tumor space, they are utilizing a disruptive approach to research and development and fostering a very collaborative learning culture. This company is making strides towards a cure for cancer.


    They are currently looking for a Research Assistant for their CAR T Cell Construct Team. This is a great opportunity for anyone looking to expand their career and be in a startup environment.


    Qualifications:

    • Responsible for CAR T cell production and functional evaluation.
    • Normal and patient donor T cells phenotypic screening and evaluation
    • Familiarity with key principles of cellular and molecular immunology.
    • Expertise with use of common immunology assays such as cytokine determinations, cellular proliferation, CTL assays, ELISAs, flow cytometry, etc.
    • Expertise in basic assays related to evaluation of RNA and protein expression (QPCR, westerns, etc.)
    • Expertise with pertinent analysis software (Prism, Flow Jo, Spotfire, Geneious, etc)

    Preferred Additional Skills:

    • Experience with transcriptional analysis such as RNA-Seq, ATAC Seq and single cell analysis
    • Prior experience working with human samples, specifically primary T cell culture
    • Experience with Electronic Lab Notebook (ELN) systems

    We are moving quickly on this role, so please don’t hesitate to apply!

  • USA

    Competitive Salary + Benefits
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    We are currently working alongside a groundbreaking next generation sequencing technology company, who are looking to bring the power of NGS to help patients around the world. Enhancing the capabilities of any DNA sequencing platform, their patented biochemistry and bioinformatics will revolutionize cancer diagnostics and monitoring.

    They are currently looking for a Regulatory Affairs Specialist to join their team. In this role, you will focus on overseeing and supporting the regulatory projects that align with the company’s goals. You will also be ensuring that all documentation is compliant with FDA regulations and ICH guidelines. You will also be submitting accurate and timely reports in order to produce PMA documents. Furthermore, you will keep internal regulatory affairs policies and procedures up to date in order to ensure compliance is maintained or enhanced.
    Qualifications:

    • 2+ years submitting 510(k) or PMA documents
    • 2+ years of managing IVD/Class III Medical Device Projects
    • Expert at writing, reviewing and editing technical documents
    • Excellent organizational skills and ability to support multiple projects

    We are moving quickly on this role, so please don’t hesitate to apply. Please also feel free to reach out directly to sarah.r.a4lgdx1gt22i@skillsalliance.aptrack.co.

  • USA

    Competitive Salary + Benefits
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    We are currently working alongside a groundbreaking clinical stage biotechnology company, who are developing first in-class intranasal drug treatments for patients suffering with CNS diseases. Their goal is to create life changing and innovative therapies that are easy to use for both patients and caregivers.

    They are currently looking for a Director of Clinical Quality Assurance to join their team. In this role, you will be managing the Clinical QA activities to support GCP and Clinical Trial obligation. You will also be working with Clinical Operations to provide support for vendor, site, and internal audits as well as maintaining CQA compliance for ongoing and planned clinical trials. In addition to managing audits and maintaining compliance, you will be working with Clinical Operations and the Regulatory Affairs department to review IND and NDA submission documents and ensure that documents meets GCP guidelines.

    Qualifications:

    • 7+ years of clinical and quality experience
    • Experience with ICH audits
    • Experience working with an ECM system, specifically MasterControl
    • Experience working with suppliers
    • Experience working with FDA, GCP, and CQA control systems

    We are moving quickly on this role. so please don’t hesitate to apply. Please also feel free to reach out directly to sarah.r.a4lgdx1gt22j@skillsalliance.aptrack.co.

  • USA

    $200000 - $220000 per annum, bonus, relocation etc
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    Title: Senior Director of Clincal Supply Chain

    Location: Foster City, Ca


    My company has been engaged by an industry leader whose vast portfolio of over 20 products are benefiting millions of people. This organization’s therapeutic areas of focus include HIV/AIDS, cancer and liver diseases.

    Now, they are seeking a Clinical Supply Chain expert to lead the end-to-end clinical supply responsibilities. In this role you will gain exposure to both a diverse portfolio of programs and a wide range of therapeutic agents including small molecules, biologics and cell therapy.

    Qualifications:

    • Lead end-to-end clinical supply responsibilites
    • Roled out system implementations
    • Directly managed clinical trials
    • Strong mix of strategic and Technical background
    • Worked on complex trials and multi-country studies

    We are actively interviewing for this position. After applying please expect to be contacted by a recruiter promptly.

  • USA

    Competitive Pay + Benefits
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    We are currently working with a Seattle-based medical device company, whose goal is to improve vision for patients all around the world with their exceptional eye products. What’s special about this company is that all their products are designed specifically by eye surgeons.

    They are currently looking for a Buyer/Planner Associate to join their growing team. This is a great opportunity for a candidate who wants to grow within a great organization and work in a very collaborative environment.

    • Ensuring material availability to support the production schedule
    • Support new product development
    • Manage and resolve issues regarding PO to invoice
    • Secure and analyze quotations as well as negotiate prices and terms with suppliers
    • Collaborate with internal customers

    The role will start off as a contract position, with the opportunity to become a permanent employee after 3 months.

    We are moving very quickly with this role, so please feel free to reach out as soon as possible!

  • USA

    Competitive Pay + Benefits
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    We are currently working with a Seattle-based medical device company, whose vision to improve vision for patients all around the world with their exceptional eye products. What’s special about this company is that all their products are designed specifically by eye surgeons.

    They are looking to add a Material Handler to their growing team! This is a great opportunity for a candidate who wants to grow within an organization and work as the right hand person to the Shipping Manager.

    • Maintain stock on existing inventory as well as fulfill orders
    • Responsible for unloading product deliveries, staging products, and assisting with organizing inventory
    • Follow SOP’s for medical device quality system regulations
    • Provide strategic vision and be able to take the initiative with helping with process improvement
    • Assisting in expanding new product line

    We are moving very quickly with this role, so please feel free to reach out as soon as possible!

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    Title: Senior Manager Regulatory Medical Writer

    Location: Remote/ Santa Monica

    We have recently partnered with a company, located in Santa Monica, CA, that is dedicated to achieving one of the most ambitious goals of 21st century medicine: curing cancer. For the past 3 decades this client has been at the forefront of cancer immunotherapy. This company develops products with a primary focus on genetically engineered autologous T cell therapy with chimeric antigen receptors. As of today, they are a leader in engineered T Cell therapy.

    Now, they are seeking a Senior Manager, Regulatory Medical Writer to join this company on their mission to cure cancer. This position will serve as the lead writer for assigned programs and will be responsible for writing and delivery of clinical documents for INDs, BLAs, MAAs, and associated regulatory submissions.

    • 5+ years of industry experience in regulatory writing
    • Degree in Life Sciences preferred
    • Experience with writing, editing and reviewing content of clinical trial-associated documents
    • Lead document preparation for major filings (e.g., BLAs, MAAs, IND) including development and management of document timelines and resource planning
    • Strong scientific background in cellular immunology, oncology or related discipline

    Given the nature of the organization and role, very exciting career progression, compensation and remote work are available.

    We are moving quickly on this role, so please don’t hesitate to apply.

  • USA

    Competitive Salary + Uncapped Commission
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    One of the nation’s fasting-growing bioanalytical laboratories is currently looking to expand their Business Development team by bringing on an additional Key Account Manager, responsible for leading and managing global strategic accounts by partnering with key executives of top pharmaceutical companies.

    The Position:

    The Key Account Manager is an integral player in developing and executing strategies to result in long-term profitable growth for both regional and international accounts.

    Responsibilities

    • Establishing professional and productive relationships with senior executives on client accounts
    • Exhibit a thorough understanding of the bioanalytical services market and deliver on accounts
    • Demonstrate high ability to develop sound strategies in-line with goals of the organization
    • Effectively and proactively communicate with Sales Management and Customer Service teams

    Qualifications:

    • Bachelor’s degree in business administration or science-related field such as biotechnology, molecular biology, or immunology
    • Minimum of 10 years’ sales leadership, account management, or industry experience
    • Must reside in one of these select metropolitan areas: Chicago, Indianapolis, Kansas City, Boston, New York City, Washington D.C., or Philadelphia

    If interested, please apply though the website. For additional information, please contact Holly Witter at Skills Alliance – Seattle.

  • USA

    Competitive Salary + Uncapped Commission
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    One of the nation’s fasting-growing bioanalytical laboratories is currently looking to expand their Business Development team by bringing on an additional Business Development Director, responsible for identifying and establishing new business relationships across both pharmaceutical and biotechnology industries.

    The Position:

    The Business Development Director is directly responsible for driving revenue growth and market positioning by identifying and closing new business relationships in an assigned region. This role interacts cross-functionally with members of scientific operations, marketing, and senior management.

    Responsibilities

    • Identifying key decision makers from targeting organizations, establishing long-term relationships
    • Prospecting, qualifying, and prioritizing new business leads
    • Developing and maintaining a full business pipeline of prospective clients
    • Providing accurate reporting of pipeline, account plans, and territory management activities

    Qualifications:

    • Bachelor’s degree in business administration or biological science (preferred)
    • Minimum of 5 years’ sales leadership, account management, or industry experience
    • Must reside in one of these select metropolitan areas: New York City, Washington D.C., or Philadelphia

    If interested, please apply though the website. For additional information, please contact Holly Witter at Skills Alliance – Seattle.

  • USA

    Competitive Pay + Benefits
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    We are currently working alongside a groundbreaking next generation sequencing technology company, who are looking to bring the power of NGS to help patients around the world. Their non-invasive assay platform has been validated to detect all four major types of genetic alterations known to drive cancers. Enhancing the capabilities of any DNA sequencing platform, their patented biochemistry & bioinformatics will revolutionize cancer diagnostics and monitoring.

    They are currently looking for a VP of Software Development to join their team. This role will be essential to the company as they are seeking someone to lead their Software team, specifically, as they look to begin the PMA process within the next year It will be essential towork closely with Regulatory teams. Your expertise and leadership will be a huge contribution to this cutting-edge technology and making sure it gets to as many cancer patients as possible.

    Qualifications

    • 8+ years professional experience in Medical Software Development
    • Experience working on a Software as a Medical Device
    • Experience using AWS platform
    • Proven leader managing and leading teams

    We are moving quickly on this role, so please don’t hesitate to apply.

  • USA

    Competitive Pay + Comprehensive Benefits
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    We are currently working alongside a groundbreaking next generation sequencing technology company, who are looking to bring the power of NGS to help patients around the world. Their non-invasive assay platform has been validated to detect all four major types of genetic alterations known to drive cancers. Enhancing the capabilities of any DNA sequencing platform, their patented biochemistry & bioinformatics will revolutionize cancer diagnostics and monitoring.

    They are currently looking for a Director of Quality Assurance. Specifically, this role will work with the revisions of the Quality Management System, as well as appropriately task and manage the Quality team. Your expertise and leadership will be a huge contribution to this cutting-edge technology and making sure it gets to as many cancer patients as possible.

    Qualifications
    • Extensive experience with QMS
    • Knowledge of PMA processes
    • Medical Device experience, preferably IVD
    • Proven experience in management position

    We are moving quickly on this role, so please don’t hesitate to apply!

  • USA

    Competitive Salary + Comprehensive Benefits
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    Location: Seattle, WA

    We are currently working alongside a groundbreaking next generation sequencing technology company, who are looking to bring the power of NGS to help patients around the world. Enhancing the capabilities of any DNA sequencing platform, their patented biochemistry & bioinformatics will revolutionize cancer diagnostics and monitoring.

    They are currently looking for a Senior Software Engineer to join their team. In particular, this role will focus on the development off their genomics analysis software system. Your contributions in this role will help enhance and evolve the cloud-based genomics analysis pipeline; ready our software systems to meet important regulatory milestones; scale to meet 10x increase in patient/tests delivered over the next year; and add significant new capabilities.

    Qualifications

    • 5+ years professional experience in software development, experience leading teams a plus
    • Polyglot background with Python and/or PERL fluency
    • Demonstrated experience with design, development and testing of significant cloud-deployed software systems
    • Broad experience with AWS, especially serverless platforms (e.g. lambda, ECS) and supporting services
    • git/GitHub/gitflow


    We are moving quickly on this role, so please don’t hesitate to apply.

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    Für den Aufbau einer Praxis suchen wir für unser Kunde noch ein/e Facharzt / Fachärztin für die Allgemeine Innere Medizin mit Schwerpunkt Geriatrie 60-100%.

    Breite klinische und ambulante Berufserfahrung sowie Kenntnisse in der schweizerischen Gesundheitswesen werden Vorausgesetzt.

    Wir bieten Ihnen ein verantwortungsvolles und innovatives Tätigkeitsfeld in einem kompetenten Team an.

    Gerne geben wir Ihnen mehr Auskunft darüber.

    Ihre Ansprechspartnerin:
    Jessica Demirtas
    Ärztevermittlung D-A-CH
    +41 43 508 73 11

    Wir freuen uns auf Ihre Bewerbung!

  • USA

    Competitive Salary + Benefits
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    We are currently working with a Clinical Stage Biotechnology company in Bend, OR that specializes in the development of innovative drug therapies to improve the lives of patients with metabolic and orphan diseases. This company is currently located in one of the fastest growing cities in America!

    This well-funded organization is seeking an Upstream Bioprocess Engineer to join their Bend based CMC team. This position will oversee the creation and implementation of manufacturing processes as well as the transfer of processes to clinical and commercial stage outsource partners. The Bioprocess Engineer will also be responsible for evaluating, defining, creating and supporting processes for the manufacture of protein therapeutics.

    Job Responsibilities/Must Haves include:

    • Managing technical relationships with CRO’s, CDMO’s, and CMO’s responsible for early and late stage manufacturers of drug substances

    • Must have a minimum of 5-10 years of upstream bioreactor development, qualification, validation and commercialization experience for monoclonal antibodies

    • Have extensive knowledge in bio-chemical analytical characterization of proteins, mAbs, fragments and biologics • Have understanding of or exposure to biological analytical test methods such as SE-HPLC, CE-SDS, cIEX, ELISA, and HILIC

    • Experience using statistical design and analysis programs to include JMP

    We are moving quickly on this role! If this sounds like a great opportunity for you, please reach out directly!

  • UK

    £65000 - £75000 per annum, bonus + benefits
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    A very rare opportunity for an experienced Senior Study Manager or Clinical Program Manager to join an exciting niche start-up Biotech, this position is permanent and office-based in Central London.

    This position is with a start-up and niche Biotech who work in gene therapy and will offer very exciting long-term prospects. This is quite a unique opportunity to join the company at early stages so there will be a lot of exposure. They work in exciting and innovative therapy areas.

    The Clinical Program Manager role is a great opportunity for an experienced individual to work on exciting gene therapy projects on an international basis, they need someone with excellent study management expeirence, working on a cross-functional basis. Line management experience would be of benefit too. The trials span phases I-III.

    This is a permanent and full-time position. It is office-based in London offering around GBP 65-75K depending on experience + bonus + benefits.

    Skills Alliance are the exclusive partner for this role, please contact Mark Anderson for more details +44 207 220 6209 or click APPLY NOW!

  • UK

    £65000 - £75000 per annum, excellent package
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    A very exciting opportunity to join a fast growing Biotech. Permanent Senior Clinical Trial Manager or Senior Clinical Study Manager role based in Hertfordshire offering an excellent salary and package.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Senior Study Manager, this would be working on interesting early phase studies. They require a strong clinical trial management background, ideally experience in early phase, complex TAs and ideally program level experience. It would be overseeing one of their two programs.

    This is a full-time and permanent position. It is office-based in Hertfordshire with flexibility to work from home. They offer an excellent salary and package around GBP 65-70K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this CPM / Senior CPM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • UK

    £45000 - £55000 per annum, excellent package
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    A very exciting opportunity to join a small and growing Biotech. Permanent Clinical Study Manager or Junior Clinical Study Manager role based in Surrey and working in cell and gene therapy.

    This exciting and innovative Biotech are at early stages with trials working in a range of disease areas in advanced therapies. They will be expanding and will offer great long-term prospects. The company are looking for an experienced CRA or Junior Study Manager or Study Manager to join the team, this would be working on studies at the cutting edge of science.

    This is a full-time and permanent position. It is office-based in Surrey with some flexibility to work from home for the right candidate. They offer an excellent salary and package around GBP 45-60K depending on experience + bonus + extensive benefits.

    Skills Alliance are the exclusive partner for this Junior Clinical Study Manager / Junior Clinical Trial Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • UK

    £50000 - £60000 per annum, excellent package
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    A very exciting opportunity to join an established Biopharma. Permanent Clinical Study Manager role based in West London and working in cell and gene therapy, specifically in Oncology.

    This World-class Biopharma work in a range of disease areas but are recruiting specifically for their Oncology team to work in Cell Therapy. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Study Manager or Junior Study Manager to join the team, this would be working on studies at the cutting edge of science. Oncology experience is required.

    This is a full-time and permanent position. It is office-based in West London with flexibility to work. They offer an excellent salary and package around GBP 50-60K depending on experience + bonus + extensive benefits.

    Skills Alliance are the exclusive partner for this Clinical Study Manager / Clinical Trial Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

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    Skills Alliance has partnered exclusively with a world-leading pharma company to hire a Director, Advanced Biostatistics in Philadelphia. The organization has a large portfolio of innovative and established medicines with numerous market-leading positions.

    This is a key and influential position in the company’s Center of Excellence for Advanced Biostatistics as they continue to invest in and grow their team. The focus of the role is to design and deliver statistical methodology and software that will help the organisation’s drug development, from early discovery to post-launch.

    Additional responsibilities include:

    • Enable quantitative decision-making to support the drug development process
    • Implement novel design for biomarker-related studies
    • Use of statistics to identify clinical endpoints and manage trial cancellation
    • Collaborate with internal and external groups to advance the use of statistics across the organisation
    • Enable the organisation to take advantage of new statistical methods

    The successful candidate will have:

    • Advanced degree (PhD or equivalent) in biostatistics, statistics, etc.
    • Minimum of 4 years’ experience, ideally within the pharmaceutical or healthcare industry
    • Strong publication record
    • Significant technical statistical competency
    • Experience using some of the following: SAS, R, Stata, Python, Java
    • Knowledge of biostatistical methods used in drug development

    The salary and benefits are highly competitive and dependent on the level and depth of previous experience.

    For a full client briefing and job description, please call Oliver Drew, Head of Executive Search Delivery, on +44 (0) 203 862 9603 or click APPLY to arrange a confidential discussion.

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    My client is a leading Biotechnology Life Sciences Organisation, who are seeking an experienced Procurement Manager with a strong international track record delivering savings and value-add initiatives across a variety of indirect categories, ideally including marketing. This will be an initial 6 month contract.


    The Role:

    You will be responsible for implementation of an EMEA marketing category strategy across multiple established European regions. This strategy is fully endorsed by the regional EMEA commercial leadership team, and implementation planning is already underway. Key focus for this role is to project manage the implementation of the agreed strategy, by collaborating and influencing cross-functional teams; align to and support business goals and develop and execute implementation plans to ensure the benefits of the category strategy are fully realised.

    Key Accountabilities:

    • Business engagement with business leads and cross functional teams across European affiliates and regional headquarters
    • Project management – lead cross-functional teams to deliver the agreed strategy within the planned timeframe
    • Organize project management support for various functional areas, attend sub-team meetings; organize ad hoc working groups
    • Gather stakeholder and subject-matter insights/business requirements to ensure effective delivery of the program
    • Effectively manage ongoing project communications to multiple stakeholders to maintain momentum and secure engagement
    • Ability to analyse spend data to track project value delivery against approved business case
    • Lead ongoing supplier negotiations, within the framework of the agreed Global agreement
    • Contribute to Global implementation planning and change management initiatives

    Required Experience and Approach:

    • Demonstrated excellence in project management, background and experience in working in Procurement across indirect categories, and ideally with some marketing category experience.
    • Previous experience in the Life Sciences industry is preferred, but not essential. Pharmaceutical, Biotechnology, Medical Devices for example.
    • Strong delivery focus – able to deliver against timelines and achieve results
    • Can-do mindset. Flexible, positive thinker that can find the way to get things done in a complex and fast moving environment
    • Understands good project governance and structure but is able to be pragmatic
    • Good facilitator. Running project meetings and workshops delivering on objectives by engaging participants
    • Excellent communicator. Credible, articulate and authoritative
    • Resilience under pressure will be a distinct advantage in the role
    • International Project Management experience would be beneficial
    • Project Management qualifications i.e. APM, PMP, PRINCE2 desirable
    • Experience using e-Rooms, Sharepoint and Microsoft office applications to a high level of proficiency
  • £120000 - £135000 per annum, car allowance, bonus, standard benefits
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    My client are looking for a Snr Director of Clinical Development to join their Clinical Research team working in Oncology-late phase clinical trials.

    Medical Degree and previous Oncology Clinical Development experience are strict requirements.

    If you are interested in this opportunity, please get in touch with Silvia Gullone at Skills Alliance (02072206219).

  • UK

    Competitive salary + benefits
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    An exciting medium size, privately owned CRO is looking for a CRA II or Senior CRA for their operations in UK.
    It is a great opportunity for an experienced Clinical Research Associate or a CRA II/Senior CRA to undertake more responsibilities and work on challenging studies, in complex therapeutic areas in a company that offers great career progression opportunities as they expand their European Operations as well as close collaboration with management.

    You would be responsible for overseeing the monitoring and start-up activities for their UK operations undertaking diverese tasks.

    This Senior Clinical Research Associate role is an office based position based in London, with slightly reduced travel. It is a permanent role and there is a competitive salary and package.

    Skills Alliance are the preferred supplier for this role. Please contact Maria Matei for more details on +44 203 948 5299.

  • USA

    Competitive
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    This well-established bioagricultural organzation is seeking a Tax Senior to join their growing team in the Raleigh-Durham area. The individual in this role will be responsible for duties within a global scope – interacting with management and other employees worldwide.

    Responsibilities:

    • Prepare, analyze, and review foreign and domestic entity level and consolidated tax provisions
    • Collaborate with research and planning on various tax issues; analysis of proposed legislation and new tax laws
    • Prepare consolidated and separate company federal, state, and local corporate tax returns
    • Prepare technical tax memoranda

    Qualifications:

    • Bachelor’s degree in Accounting; Master’s degree preferred
    • No less than three years’ experience in corporate tax
    • Certified Public Accountant required
    • Experience with OneSource or other tax preparation and tax provision applications

    If interested, please apply though the website. For additional information, please contact Holly Witter at Skills Alliance – Seattle.

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    One of the nation’s fastest-growing bioanalytical laboratories is currently looking to expand their Quality Assurance team by bringing on an additional Quality Assurance Auditor, responsible for positively impacting the organization through successful contributions, active participation, and identification of compliance gaps.

    Responsibilities:

    • Performing QA audits, inspections, and monitoring procedures
    • Assisting in writing and reviewing QA standard operating procedures
    • Assisting in documentation management activities
    • Assisting in hosting regulatory inspections by acting as scribe and/or reviewing documents

    Skills:

    • Microsoft Excel and Word proficiency

    Qualifications:

    • Bachelor’s degree in scientific field or related discipline
    • Minimum of two years’ experience in quality assurance
    • Experience working in related industry/similar organization
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    A very rare opportunity for an experienced Events or Congress manager to join an exciting innovative pharmaceutical company specialising in Oncology in the Oxfordshire area.


    Together with the Senior Management and EU and Global teams, the Congress & Events Manager will manage the expansion and implementation of the congress plan for congresses in EU as well as working on the organization of internal and external events.

    As part of this company, you’ll have the opportunity to gain international exposure to further expand your niche skillset and will be working alongside some of the world-leading experts in this field.

    Requirements:

    • Educated to Degree Level
    • At least 3 years’ experience working in the pharmaceutical industry or in a corporate events management role is vital
    • Strong analytical skills and systematic way of thinking
    • Excellent interpersonal skills; sensitive to different cultures and backgrounds, must be very tactful and diplomatic

    This is a permanent and full-time position. It is office-based offering a competitive salary depending on experience + bonus + benefits.

    Skills Alliance are the exclusive partner for this role, please contact Warda Issa for more details +44 203 823 4158 or click APPLY NOW!

  • €71000 - €81000 per annum
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    An innovative medical device start up is looking for a Regulatory Affairs & Quality Assurance Specialist in Lausanne to establish and maintain the quality assurance system of the company and ensure its regulatory compliance.

    Responsibilities

    • Assuring and monitoring the compliance of the company with relevant Q&R norms ( EU+US)
    • Coordinating and managing QA system ( ISO 13485, FDA 21CFR820)
    • Planning, organizing and implementation of internal and external audits
    • Maintaining internal audits, CAPA activities
    • Developing QA conducting risk analyses; identifying critical control points and preventive measures; establishing critical limits; monitoring procedures, corrective actions, and verification procedures.
    • Developing post-market surveillance plans and managing post-market surveillance and vigilance activities.
    • Monitoring and ensuring remaining all of the regulatory expenses within the given budget.
    • Managing quality issues and interacting with R&D team and products suppliers regarding these.
    • Reviewing and investigating customer complaints, determining product failure root causes and evaluating a risk of failures.
    • Ensuring understanding and applying of the quality system throughout the organization on all levels
    • Authorizing product release to stock and completion of relevant records upon receipt.

    Requirements

    You have

    • Min. 3 years in QARA function or equivalent experience.
    • Bachelor’s in Science, Engineering, Engineering management or related discipline
    • Experience with ISO13485 and FDA 21CFR 820, IVD medical devices & reagents. ( FDA and EU Notified Bodies as a plus)
    • Strong oral and written communication and presentation skills.
    • Knowledge of office suites softwares, with an ability to learn other computer based systems

    You can

    • manage complex projects and timelines in a matrix team environment.
    • independently identify compliance risks and escalate when necessary.
    • lead and coach others.
    • Speak fluent English (French is a big plus).

    Are you interested? Kindly contact Maria Nosach on +41 43 501 64 60 for more information.

  • Competitive
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    We are currently partnered with an exciting pharmaceutical company who are currently undergoing a large build across Europe, focused in the areas of Oncology and Hematology. They are currently looking for an MSL Head to cover the region surrounding Frankfurt and lead their new and expanding team of MSLs. This is a great opportunity for someone who has both worked in Onco/Haem as well as having extensive experience as an MSL across Germany.

    Job Responsibilities

    • Cooperation with specialists and opinion leaders in the field of oncology.
    • Leading a team of MSLs nationwide.
    • Working closely with the Medical Director to build a strong strategy for the MSLs.
    • Building new relationships with regional and national stakeholders.
    • Close cooperation with in-house departments regarding site strategy and identification of clinical topics and research opportunities
    • From time to timne, training for MSLs will be needed
    • Participation in medical and scientific conferences at home and abroad
    • Close cooperation with the MSL team in other European countries.

    Candidate Requirments

    • PhD essential
    • 2 years + MSL experience
    • Extensive Oncology and/or Hematology experience
    • Experience in planning and initiating projects advantageous
    • Excellent communication and negotiation skills
    • Fluent German and English spoken and written
    • Willingness to travel extensively and a high degree of flexibility
    • Experience of leadership.

    Please apply here if interested in this opportunity – or for a confidential discussion please contact Matt Jamison at Skills Alliance.