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  • Regulatory Affairs

    $140000 - $160000 per annum
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    Skills Alliance is partnered with a rapidly growing Biopharma organization in the greater Boston area. This company is focused in the Rare Disease space but plan to expand their horizons through collaborations and acquisitions of companies. This ultimately enables one to work on a diverse pipeline that varies in therapeutic areas and phases of studies.

    The Regulatory department is looking for an Associate Director of Regulatory Affairs to join the team. This leader would be responsible for strategy aspects of submissions. The AD would be responsible for submitting INDs, BLAs, and CTAs to governing bodies and lead project teams. These responsibilities make the AD the point person for some exciting product developments over the next twenty four months. Along with the interesting nature of the strategy work you will have the opportunity to manage a team of Regulatory Strategy and operations individuals and grow with this rapidly expanding organization.

    The ideal AD of Regulatory Affairs would have:
    -IND, BLA, CTA submission experience
    -Engaged with Regulatory Agencies directly

    If interested in learning more about the opportunity feel free to call 646-300-8377

  • Regulatory Affairs

    $140000 - $160000 per annum
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    Skills Alliance is partnered with a rapidly growing Biopharma organization in the greater Boston area. This company is focused in the Gene Therapy space but plan to expand their horizons through collaborations and acquisitions of companies. This ultimately enables one to work on a diverse pipeline that varies in therapeutic areas and phases of studies.

    The Regulatory department is looking for a Sr. Manager/Associate Director of CMC Regulatory Affairs to join the team. This leader would be responsible for strategy aspects of submissions. The AD would be responsible for providing input on all matters pertaining to CMC. The Sr. Manager/ Assosicate Director would also have the opportunity to lead a project team as well. These responsibilities make the AD the point person for some exciting product developments over the next twenty four months. Along with the interesting nature of the role there is a hihgly competitive package including a substantial amount of equity included.

    The ideal AD of Regulatory Affairs would have:
    -Strong background in CMC sections of submissions
    -Engaged with Regulatory Agencies directly

    If interested in learning more about the opportunity feel free to call 646-300-8377

  • USA

    Commercial

    Competitive
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    I have an exciting career progressing opportunity for Sales Executives/Sales Representatives professionals, specialized in B2B sales, working with a Global Pharmaceutical Discovery based Software Company. This is a permanent/full-time position, remote/home-based, with an excellent salary and benefits package as well.

    The essential function of the role will involve building, managing and maintaining pipeline of new and existing users and prospective clients, demonstrating/presenting software, responding to users sales inquiries, negotiating agreements, meeting sales budgets, attending exhibitions and meetings as needed, maintaining CRM database, and providing user feedback.

    Must have experience with B2B sales and complex sales. Structural science, crystallography or software development experience is a plus.

  • USA

    Clinical research

    $325000 - $400000 per annum
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    Skills Alliance is partnered with an exceptional biotech in the north east that is looking to bring on board a VP of Clinical Development. My client is an oncology focused biotech that is rapidly growing in the Tri-State area and they are looking to bring onboard another pillar of the company.

    The VP must be an M.D. that excels in small teams. This individual will be reporting into the CEO and will be pivotal for the development of their assets. The ideal candidate would have spent most of their career in the oncology space and been exposed across all phases of studies. The assets that the VP would cover will be primarily late phase work, which enables one to have the possiblity to bring a product to market soon. The Vice President will also have the ability to shape the culture and the team underneath them as they are working hand in hand with the CEO in this role. Great opportunity for mentoring junior staff and having leadership responsibilities.

    Along with the very interesting nature of this role, the compensation package can be very lucrative as well.

    If you were interested in learning more about the opportunity, please submit a copy of CV for consideration.

  • Quality assurance

    €48000 - €55000 per annum
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    A leading global biotechnology company focused on rare diseases based in Belgium is currently looking to hire on permanent based Quality Validation Engineer offering an excellent salary and package.

    This exciting biotech is rapidly growing and will offer great long-term prospects. The company is looking for a Quality Validation engineer who will be responsible for all aspects in validation/ quality such as validation of processes, utilities, computer systems, automation etc. You will be responsible to review/approve of validation documentation, specification documents (URS, Functional/ Design Specification) and study protocols/ reports (IQ/ OQ/ PQ/ PPQ). Review and approval of test incident occurred during the validation in a quality perspective

    Participate and approve of the risk analysis linked to validation activities. Review/approve of periodic review of critical system to ensure compliance to procedures and regulatory requirements. The Quality Validation team is a global department responsible for the quality oversight of all manufacturing validation activities (utilities/building/ purification/ fill & finishing and packaging) performed on site.

    The company requires a Bachelor or master’s degree in engineering, chemistry, life science, or other jobrelated discipline. Good experience in quality or validation related activities and fluent in both English and French.

    This is a fulltime and permanent position. The office is in Hainaut, a province in Wallonia, Belgium.

    Skills Alliance are the preferred supplier for this global biotech company. For more information, please contact Erica Luijk on 0041 435 080 379.

  • Clinical Operations

    £60000 - £75000 per annum, Benefits: excellent package + equity
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    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Study Manager or Senior Clinical Study Manager role based in Oxfordshire offering an excellent salary and package.

    This exciting and innovative Biotech company 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 Study Manager to join the team, this would be working on interesting early phase studies in Oncology.

    This is a full-time and permanent position. It is office-based in Oxfordshire with flexibility to work from home for the right candidate. They offer an excellent salary and package around GBP 60-75K depending on experience + bonus + extensive benefits.

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

  • Clinical Operations

    £60000 - £75000 per annum, Benefits: excellent package + equity
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    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Study Manager or Senior Clinical Study Manager role based in Oxfordshire offering an excellent salary and package.

    This exciting and innovative Biotech company 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 Study Manager to join the team, this would be working on interesting early phase studies in areas other than Oncology.

    This is a full-time and permanent position. It is office-based in Oxfordshire with flexibility to work from home for the right candidate. They offer an excellent salary and package around GBP 60-75K depending on experience + bonus + equity + extensive benefits.

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

  • Medical Devices

    £30000 - £40000 per annum, Benefits: 10% Bonus + Pension + Health and Dental
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    This is a unique and exciting opportunity to join a medical device company specialised in treating breathing disorders. Our client is seeking a permanent Industrialisation Engineer to start working in Wiltshire county.

    You will be responsible for supporting a new product introduction. By working in collaboration with the quality department, you will establish attribute to enable a compliant and efficient transfer to a contract manufacturing organisation. You will be communicating and managing suppliers and sub contractors and be a representative of the industrialisation group. You will be constantly striving to improve the device and provide feedback on processes.

    To be considered for this role, you bring experience in industrialising, manufacturing or designing products in a regulated industry accompanied by a degree in engineering, science or another related field. Prior understanding of development activities is appreciated. If this opportunity is of interest to you, please contact Khephren Mongongu +41 43 508 29 16 or click apply to continue.

  • CRA

    £40000 - £50000 per annum, Benefits: benefits
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    I am partnered with a small global Oncology CRO who are looking for an experienced CRA to move away from a full-time monitoring position and into a training role. This is a rare opportunity for someone who has a keen interest in developing and coordinating clinical research associates and who is keen to drastically cut down on travel (30%).

    You will be responsible for within the business, improving monitoring strategies and co-monitoring. You will also work closely with the leadership team.

    Responsibilities:

    • Train and develop existing and new CRAs within the business (co-monitoring, report reviews etc)
    • Improve and help develop new monitoring strategies
    • Work in-conjunction with management team.

    Experienced Required:

    • Minimum of 3 years CRA experience which includes training and mentoring of CRAs.
    • Oncology experience strongly preferred
    • CRO or Pharma background

    Please contact Troy Neenan from Skills Alliance on 02072206237 to find out more or click apply.

  • HR and talent acquisition

    Competitive Rate of Pay
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    A rapidly growing Biopharmaceuticals company is seeking a senior Talent Acquisition professional to perform targeted full lifecycle recruitment and project manage the build-out of a new function.

    The Internal Recruiter will act as a centre of excellence for recruitment activities and offer a consultative approach to senior stakeholders, whilst executing innovative sourcing strategies.

    Responsibilities include:

    • Build and maintain a network of diverse candidates using a multitude of resourcing methods
    • Represent the company in a positive and professional manner, creating an attractive employer brand to candidates considering joining the business
    • Partner closely with stakeholders to guide them through the interview and selection process, clearly defining processes and coaching through interviews
    • Build strong relationship with the hiring managers and understand the types of profiles and cultural fits that will meet their staffing needs
    • Build and maintain relationships with third-party recruiters, facilitating liaison between recruiter and hiring managers

    Required Experience:

    • 5+ years of full lifecycle recruitment
    • Extensive knowledge of the Pharmaceuticals sector and experience recruiting clinical operations and R+D professionals
    • Fluent English and French language skills preferred

    Why Apply?

    • Dynamic environment with long term vision and values
    • Opportunity to hire the scientists at the forefront of research in the industry
    • Opportunity to demonstrate innovation and creativity in an autonomous environment

    Please contact Sarah Brambill from Skills Alliance for immediate consideration.

  • Clinical Operations

    £55000 - £65000 per annum, Benefits: bonus + benefits
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    A very rare opportunity for an experienced (Senior) Study Manager or (Senior) Trial Manager to join an exciting niche start-up Biopharma, this position is permanent and office-based in London.

    This position is with a small and niche Biotech 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 Senior Clinical Trial Manager role is a great opportunity for Study Manager to work in a wide ranging study management role, including program oversight, line management and working on a cross-functional basis. They require a strong project management management experience from Pharma or CRO. This would be working on early phase trials.

    This is a permanent and full-time position. It is office-based in London offering around GBP 55-65K depending on experience + bonus + benefits.

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

  • Clinical Operations

    £60000 - £70000 per annum, Benefits: excellent package
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    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Project 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 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 overseeing CROs and vendors.

    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 60-70K depending on experience + bonus + extensive benefits.

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

  • Clinical Operations

    £55000 - £70000 per annum, Benefits: excellent package
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    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Study 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 Study Manager to join the team, this would be working on interesting early phase studies.

    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 55-75K depending on experience + bonus + extensive benefits.

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

    Key words: Clinical Study Manager / Clinical Trial Manager / Global Study Manager / Senior Study Manager / Senior Clinical Study Manager / Pharma / Biopharma / Biotech / Berkshire / London / Hertfordshire / Buckinghamshire / England / UK / permanent / Surrey / advanced therapies / gene therapy / cell therapy / ATMP

  • Medical affairs

    €90000 - €120000 per annum
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    Skills Alliance has been exclusively retained by a NASDAQ listed, clinical-stage biotechnology company, to hire two International Medical Science Liaisons (MSL) as part of a global team build in medical affairs.

    The company has a broad, innovative pipeline of differentiated antibody-based therapies in pivotal trials for a range of rare diseases, with a first-in-class product launch anticipated in 2021.

    The International MSLs will be based in either Germany, France, Netherlands or Belgium and will manage medical affairs activities across a small select group of Western European countries where the ongoing Phase II trials are being conducted and Phase III are about to commence.

    The product has been granted orphan drug status by the EMA and the key treatment and research centers are located in the major cities across Western Europe.

    Responsibilities:

    • Act as the field-based expert on the company’s scientific data, products and trials and reflect the company’s values as a science-driven, patient-focused organisation
    • Identify and develop productive collaborations with Key Opinion Leaders, other important customers and stakeholders, including professional organisations
    • Implement medical affairs practices to assess potential new indications, including the patient referral pathways
    • Support clinical development and clinical operations team functions
    • Identify potential investigators and centres for participation in clinical research and support feasibility assessments and site initiation
    • Proactively identify and resolve study issues at a site level
    • Develop and implement local strategies to motivate sites and enhance recruitment
    • Support the development and implementation of Medical Affairs plans to advance product development objectives
    • Deliver high quality scientific/medical education in a variety of settings, including related to diseases of interest, clinical studies, investigational products and licensed products
    • Attend appropriate local, national and international meetings and congresses to gather intelligence and develop productive collaborations

    Requirements:

    • A scientific, healthcare, pharmacy or medical degree
    • Demonstrable ability to understand and convey scientific information on complex disease areas, treatments and clinical development plans
    • Proven ability to build productive, long-lasting collaborations with medical experts
    • Excellent verbal and written communication skills with good command of the English language
    • Ability to work autonomously as part of a small, international team in a fast-paced, dynamic environment
    • A self-motivated, driven nature with a desire to deliver results that meet or exceed targeted objectives
    • Clinical or medical affairs experience in: orphan drugs / rare diseases / immunology / neurology / hematology
    • Ability to travel both nationally and internationally, as required
    • A second European language is beneficial

    A full job description is available on request.

    Skills Alliance is exclusively partnered with this organisation. Please click APPLY or call 0044 207 220 6210 to receive further information.

  • Medical affairs

    €90000 - €120000 per annum
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    Skills Alliance has been exclusively retained by a world leading, T-Cell therapy immuno-oncology Biotech, to hire two new Senior MSLs in Germany (North & South) as part of a European team build in medical affairs.

    The company’s lead programme is in pivotal trials for the treatment of a rare solid tumour indication, with the global first-in-class product launch anticipated in 2020.

    The Senior MSL will:

    • Initiate and lead the pivotal pre-launch medical affairs activities in a defined territory
    • Contribute to the country medical launch plan with the Global Medical Affairs team
    • Identify and engage with specific local, national and regional KOLs and Scientific Experts
    • Provide scientific support for clinical research activities
    • Develop strong relationships with KOLs to expand advisory and educational partnership opportunities
    • Act as a scientific expert at key medical and scientific conferences, congresses, advisory boards, investigator meetings and patient advocacy group meetings
    • Review and critique scientific publications
    • Hold local roundtables and educational programs with treaters and referral network institutions 
    • Investigate opportunities for novel educational programs with treaters and referral network
    • Coordinate interactions with academic societies, research groups, and other national organizations
    • Liaise with treaters and referral network to gather additional Drug Safety information as requested


    Requirements:

    • Practical experience in an MSL role or related, scientifically focused field-based role is required
    • Advanced degree preferred (MD, PhD, PharmD)
    • Experience and practical knowledge of immuno-oncology / oncology / cell therapy is strongly preferred
    • Knowledge of clinical research design and GCP in immuno-oncology / oncology / cell therapy
    • Knowledge and experience in working with oncology research groups
    • Excellent presentation, communication and relationship-building skills
    • Ability to travel 2-3 days per week


    The organization is a fast-paced, scientifically driven company and it offers an entrepreneurial, flexible environment with a high level of autonomy.

    The Senior MSL will demonstrate a keen passion and enthusiasm for science and a high level of self-motivation to work autonomously as part of an international team.

    The employment contract is directly with the biotechnology company and a lucrative package, including a significant amount of shares, is on offer.

    Skills Alliance is exclusively partnered with this organisation. Please click APPLY or call 0044 207 220 6210 to receive further information, including a full job description.

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    Skills Alliance has been exclusively retained by a clinical-stage biotechnology company to hire three Senior International Medical Science Liaisons (MSL) as part of a global team build in Medical Affairs.

    The company has a broad, innovative pipeline focused on autoinflammatory and autoimmune therapies in clinical and preclinical stages for a range of rare diseases. Their lead asset is first-in-class with phase III expected to commence in 2018.

    The Senior International MSLs will be based in either Germany, France or Italy and will manage medical affairs activities across a small select group of European countries.

    Job Responsibilities:

    • Create and implement strategic territory plans in line with the biotech’s scientific and business goals
    • Be the primary external point of contact for key stakeholders and promote collaboration in line with the biotech’s objectives
    • Be a reliable and trusted source for accurate medical and scientific knowledge, providing product information and the disease state as requested
    • Feed back field insights to internal stakeholders and coordinate with the biotech’s R&D team
    • Collaborate with Clinical and Regulatory teams in identifying sites, recruitment, evaluation and training to advance clinical trial execution at study sites
    • Act as primary scientific contact and resource at congresses, advisory board discussions and during internal training
    • Perform all other relevant KOL identification and engagement tasks
    • Respond to unsolicited requests for medical information in an accurate and timely manner

    Qualifications:

    • Advanced scientific degree (MD, PharmD or PhD)
    • Several years of industry experience in inflammation or immunology
    • Candidates with extensive MSL experience in a relevant therapeutic area without an advanced degree will also be considered
    • Experience in rare disease, launching orphan drugs and biologic immunotherapies
    • Willingness for up to 70% travel time

    This position would appeal to current MSL Directors looking to get back into the field and help build a Medical Affairs team and strategy from scratch.

    Skills Alliance is exclusively partnered with this innovative biotech. Please click APPLY or call 0044 207 220 6210 to receive further information, including a full job description.

  • Apply

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    Skills Alliance has been retained exclusively to hire a Senior Director Health Economics & Outcomes Research EU for a world-leading pharma company. This organisation has a large portfolio of innovative and established medicines with numerous market-leading positions. The business invested a record amount into R&D in 2017 as it continues to lead from the front, ensuring they continue to nurture a highly competitive pipeline.

    This is a new and highly anticipated leadership position responsible for representing local affiliates and their health economic, outcomes research and evidence requirements at global level across the entire pharmaceutical portfolio. In turn, aligning global strategies with local operating companies and overseeing successful execution through matrix leadership of the function across the EU will be crucial to on-going and future commercial success. The role reports to the Global Head of HEOR and will be office-based in London, United Kingdom.

    The successful candidate will have:

    • Degree in health economics, outcomes research, public health, health outcomes, or similar (PhD preferred)
    • Minimum 7 years’ experience in HEOR function within the pharma industry
    • Expertise in design of health outcomes studies, study protocols, study execution, economic modelling, and local value dossier creation
    • Knowledge of HTA processes across EU and providing HEOR support for local affiliates
    • Exceptional communication to engage and influence senior stakeholders both internally and externally (additional EU language skills are preferred)
    • Experience leading cross-functional matrix teams, including scientific and commercial stakeholders
    • Willingness to travel up to 35% within the EU


    Responsibilities of this position:

    • Provide guidance to local affiliates on their local value evidence processes, including vendor selection, proposal evaluation, GVD adaptation, and share best practices across the EU and with the global team
    • Train local affiliates on the GVD and other HEOR deliverables to ensure local payer needs are met across EU and a consistent approach is taken
    • Support local teams on new model development and evidence generation when required
    • Closely partner with local operating countries to ensure global HEOR strategies are continuously informed and to communicate local HEOR needs to the global team, supporting their local value proposals and evidence generation requests
    • Communication of local value and scientific insights to early asset teams
    • In-depth understanding of payer needs across EU, including HTA requirements, to enable successful access and reimbursement
    • Lead strategic initiatives to improve how local affiliate needs are incorporated into global HEOR planning and execution


    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 email karina.s.a4lgdx1gq2xb@skillsalliance.aptrack.co to arrange a discussion.

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    We have been retained exclusively to hire another Global Epidemiologist / Real World Evidence Scientist for a leading international Biopharma.

    With an innovative and visionary approach, this Biopharma are leading from the front to drive a fundamental shift from the traditional reliance on Randomised Controlled Trials (RCTs) data to a new Real World Data-driven era where Real World Evidence will replace RCTs as the most influential source of evidence used by external decision-makers.

    After forming a new RWE practice following significant investment and commitment from the Executive Committee, we are continuing to buildout the group. This is an opportunity to join one of the highest performing and most progressive RWE teams in the industry as they continue to drive changes to their own business and the wider Life Sciences industry.

    The role is responsible for leading the design and delivery of evidence-focused projects. It will contribute directly to the Global Epidemiology & Real World Evidence Strategy and the creation of evidence generation plans where required by the business. It will also play an essential role in helping to identify new investment and development opportunities through data analysis and forecasts. The position will collaborate closely with other functions, including Market Access, Medical Affairs, Regulatory Affairs and Clinical Operations.

    The company has created a promising pipeline to complement their strong platform of marketed products and ensure the continued growth of the business. Their culture and way of working capture their desire for excellence, to innovate, to work in a highly collaborative manner, to inspire a go-get and bias-for-action attitude, and to enjoy what they do as much as possible.

    Preferred candidates will have:

    • MSc, PhD or equivalent in the field of Epidemiology, Health Economics, Biostatistics, Public Health or similar
    • Proven ability to deliver successful Real World Evidence projects from concept stage, including study design, protocol writing, analysis oversight and report completion
    • Experience working with claims databases, patient registries and EHRs
    • Publications in professional peer-reviewed scientific or clinical journals
    • Ability to work in cross-functional teams and in an international matrix structure

    The position is based in Raleigh, North Carolina. It could also be based in London or Brussels depending on candidates’ personal circumstances. The salary and benefits are competitive and dependent on the level and quality of previous experience.

    For further details and a full job description and client briefing, please call Oliver Drew on +44 (0) 203 862 9603 or email him to arrange a discussion.

  • Biopharma

    £60000 - £65000 per annum, Benefits: car allowance + bonus
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    Medical Science Liaison – Scotland and Ireland – Exciting Neurology Portfolio

    I am currently working with a long-standing client of ours who is looking for an experienced Medical Science Liaison based in Scotland to cover their neurology portfolio.

    My client are keen to take on experienced MSLs to join their UK wide team of 3 MSLs, to work on their neurology portfolio. Their main product, a treatmet for epilepsy, is an exciting product with high deman among clinical profressionals so there will be lots to keep you busy in this role!

    Targeting the biggest hospitals in the region, to be considered for this role you must be based in Scotland. Neurology experience is not a pre-requisite.

    This is a great role for any experienced MSL to move into a more senior MSL position which allows you to potentially train and coach junior members of the team, as well as progress your own career as an MSL.
    This is also a great opportunity to work on an exciting and growing portfolio – including products for epilepsy and moving forward, Alzheimer’s disease.

    For more information about this opportunity or any similar opportunities, please contact Chanel Hicken on 0207 220 6206 or email chanel.h.a4lgdx1gq34f@skillsalliance.aptrack.co and we can schedule a time for a confidential discussion.

  • Clinical research

    £65000 - £75000 per annum, Benefits: excellent package
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    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Project Manager or Senior Clinical Project 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.

  • USA

    Clinical research

    Competitive
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    CRA I

    I have a career progressing opportunity as a CRA I, for one specialized in Oncology in the BioPharmaceutical/CRO Industry in New Jersey and looking to further their experience. This would offer career growth, and in addition a great salary and benefits package.

    Reporting to the CTM, the essential function of the role will be to coordinate all phases of the clinical trials, ensuring GCP requirements of the studies, patient safety, regulatory compliance, proper documentation, reporting and ensuring company standards are being met. The position will be on-site, Monday to Friday, with up to 40% travel to sites.

    You must have at least a Bachelor’s degree, at least 1 year of CRA experience, Oncology experience, independent on-site monitoring experience, pharmaceutical biotech or medical device industry experience.

  • USA

    Biopharma

    Competitive
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    CTA I

    I have a career progressing opportunity as a Clinical Trials Assistant, for one specialized in the BioPharmaceutical/CRO Industry in New Jersey and looking to further their experience. This would offer career growth, and in addition a great salary and benefits package.

    The essential function of the role will be to maintain/establish, review, file archive documents within TMF, TMF compliance review, assist project teams, assist with start-up/close-out activities, and support clinical study teams. This role will be on-site, Monday to Friday.

    You must have at least a Bachelor’s degree, at least 1 year experience with administrative duties, customer service, cross-functional communication, organizing/maintaining electronic files, resolve errors in computer systems and applications, pharmaceutical/biotech/medical device industry experience, CRO industry experience preferred, and Oncology experience.

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    Clinical Trial Manager

    I have a career progressing Leadership opportunity as a Clinical Trials Manager, for one specialized in the BioPharmaceutical/CRO Industry in New Jersey and looking to further their experience. This would offer career growth, and in addition a great salary and benefits package.

    The essential function of the role will be to lead/manage day to day operations, study teams, vendors, CRO’s, coordinate timelines, monitoring and co-monitoring visits, developing study plans, feasibility assessments, training, author, edit, audit written summaries of data reports, and other duties as needed.

    You must have at least a Bachelor’s degree, at least 5 years of CRA experience within the pharmaceutical/biotech industry, CRO management experience, relevant Project Management experience, familiarity with FDA GCP/ICH regulatory guidelines, and Oncology experience is a plus.

  • USA

    Regulatory Affairs

    $160000 - $185000 per annum
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    Skills Alliance is partnered with a rapidly growing Biopharma organization in the greater Boston area. This company is focused in the Auto-Immune space but plan to expand their horizons through collaborations and acquisitions of companies. This ultimately enables one to work on a diverse pipeline that varies in therapeutic areas and phases of studies.

    The Regulatory department is looking for an Associate Director of Regulatory Affairs to join the team. This leader would be responsible for strategy aspects of submissions. The AD would be responsible for submitting INDs, BLAs, and NDAs to governing bodies and lead project teams. These responsibilities make the AD the point person for some exciting product developments over the next twenty four months. Along with the interesting nature of the strategy work you will have the opportunity to manage a team of Regulatory Strategy and operations individuals and grow with this rapidly expanding organization.

    The ideal AD of Regulatory Affairs would have:
    -IND, BLA, NDA submission experience
    -Engaged with Regulatory Agencies directly

    If interested in learning more about the opportunity feel free to call 646-300-8377

  • USA

    Regulatory Affairs

    Competitive
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    Regulatory Affairs Manager

    I have an exciting leadership opportunity within Regulatory Affairs for someone specialized in CMC and Generics in the Pharmaceutical Industry. This is a permanent position in the Greater New York area, offering great benefits and salary, as well as an opportunity for advancement and growth.

    Reporting into the Senior Director of Regulatory Affairs, the essential functions of the role will be to lead and direct a team of Regulatory Associates; provide direction to R&D, Technical Operations Sales and Marketing, Clinical, Quality, and Legal; facilitate communication with CDER and FDA; participate in Pre-IND, Pre-NDA meetings; prepare, review, and file NDA, ANDA, IND, DMF and post-marketing activities; review and approve advertisements/promotional materials and change controls.

    Must have at least 3 to 7 years of regulatory affairs experience within the pharmaceutical industry. At least 1 year of previous managerial/supervisory experience also needed, as well as CMC drug product registration and US drug registration experience (NDA, ANDA, DMF, and IND). Familiarity with US Product labeling requirements is preferred.

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    Senior Director of Regulatory Affairs

    I have an exciting leadership opportunity within Regulatory Affairs for someone specialized in Regulatory Strategy and early and late stage drug development within the BioPharmaceutical Industry. This is a permanent position in the Greater Boston area, offering great benefits and salary, as well as an opportunity for advancement within a rapidly growing organization.

    Reporting into the VP of Regulatory Affairs, the essential functions of the role will be to oversee, develop and implement regulatory strategy, lead cross functional teams, and communicate appropriately with US FDA and global health authorities.

    Must have at least 5 to 7 years’ of progressive experience in regulatory affairs in the Biopharma Industry as well as early and late stage drug development experience. Must also have experience filing MAA and BLA’s, and preparing regulatory documents (IND, safety reports, IB’s, DSUR’s, briefing packages, and regulatory submissions). Must have experience with FDA regulations and EU, CTA requirements. Also must have experience directly interacting with the FDA and global health authorities. Experience with Biologics Drug Development is highly desired. Familiarity with eCTD or e-publishing is a plus.

  • USA

    Regulatory Affairs

    Competitive
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    Director of Regulatory Affairs

    I have an exciting leadership opportunity within Regulatory Affairs for someone specialized in Regulatory Strategy and early and late stage drug development within the BioPharmaceutical Industry. This is a permanent position in the Greater Boston area, offering great benefits and salary, as well as an opportunity for advancement within a rapidly growing organization.

    Reporting into the VP of Regulatory Affairs, the essential functions of the role will be to oversee, develop and implement regulatory strategy, lead cross functional teams, and communicate appropriately with US FDA and global health authorities.

    Must have at least 5 to 7 years’ of progressive experience in regulatory affairs in the Biopharma Industry as well as early and late stage drug development experience.Must also have experience filing MAA and BLA’s, and preparing regulatory documents (IND, safety reports, IB’s, DSUR’s, briefing packages, and regulatory submissions).Must have experience with FDA regulations and EU, CTA requirements.Also must have experience directly interacting with the FDA and global health authorities.Experience with Biologics Drug Development is highly desired.Familiarity with eCTD or e-publishing is a plus.

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    Associate Director of Regulatory Affairs

    I have an exciting leadership opportunity within Regulatory Affairs for someone specialized in Regulatory Strategy and early and late stage drug development within the BioPharmaceutical Industry. This is a permanent position in the Greater Boston area, offering great benefits and salary, as well as an opportunity for advancement within a rapidly growing organization.

    Reporting into the VP of Regulatory Affairs, the essential functions of the role will be to oversee, develop and implement regulatory strategy, lead cross functional teams, and communicate appropriately with US FDA and global health authorities.

    Must have at least 5 to 7 years’ of progressive experience in regulatory affairs in the Biopharma Industry as well as early and late stage drug development experience. Must also have experience filing MAA and BLA’s, and preparing regulatory documents (IND, safety reports, IB’s, DSUR’s, briefing packages, and regulatory submissions). Must have experience with FDA regulations and EU, CTA requirements. Also must have experience directly interacting with the FDA and global health authorities. Experience with Biologics Drug Development is highly desired.Familiarity with eCTD or e-publishing is a plus.

  • Oncology

    £60000 - £70000 per annum, car + bonus + equity
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    Skills Alliance has partnered with a biopharmaceutical company specialising in the development of treatment for rare diseases within oncology. Our client is looking for a key account manager (KAM) based in North East England.

    The KAM must have haematology, oncology or rare disease experience. Reporting to the sales director you will be responsible for driving sales within the territory, as part of a team of 7 KAMs nationally. You will work on an established portfolio of products, whilst being involved with the launch of a major brand-new product. The role allows you to be very autonomous whilst having the ability to call on the medical science liaison (MSL) for assistance as needed.

    You should be patient driven, customer focused and want to progress within your career.

    This is a permanent and full-time role. It is fully field-based based in the North East covering Tyne & Wear, Humberside and Yorkshire. The salary would be in the region of £60-70K + company car + 20% bonus + equity.

    To find out about this position or other similar positions within the commercial market call Marcus Carter on 0203 823 4158.

  • Oncology

    £60000 - £70000 per annum, car + bonus + equity
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    Skills Alliance has partnered with a biopharmaceutical company specialising in the development of treatment for rare diseases within oncology. Our client is looking for a key account manager (KAM) based in North West England.

    The KAM must have haematology, oncology or rare disease experience. Reporting to the sales director you will be responsible for driving sales within the territory, as part of a team of 7 KAMs nationally. You will work on an established portfolio of products, whilst being involved with the launch of a major brand-new product. The role allows you to be very autonomous whilst having the ability to call on the medical science liaison (MSL) for assistance as needed.

    You should be patient driven, customer focused and want to progress within your career.

    This is a permanent and full-time role. It is fully field-based based in the North West covering Liverpool, Manchester, North Wales and Lancashire. The salary would be in the region of £60-70K + company car + 20% bonus + equity.

    To find out about this position or other similar positions within the commercial market call Marcus Carter on 0203 823 4158.

  • Clinical research

    Competitive salary
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    One of the top 10 Global Pharma companies is looking for a Clinical Trial Manager to join their team.

    You would be responsible for coordinating their studies in Northern Europe. They require an experienced Project Manager or Study Manager who has strong international experience with Cardiology experience being preferred.

    This role is office based 4 days a week with one day working as home-based. It is a permanent, full-time position.

    Competitive salary and package are provided.

    Skills Alliance are the preferred supplier for this role. Please contact Maria Matei for more details on +44 203 948 5999.

  • CRA

    £40000 - £50000 per annum, benefits
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    I am partnered with a small global Oncology CRO who are looking for an experienced CRA to move away from a full-time monitoring position and into a training role. This is a rare opportunity for someone who has a keen interest in developing and coordinating clinical research associates and who is keen to drastically cut down on travel (30%).

    You will be responsible for within the business, improving monitoring strategies and co-monitoring. You will also work closely with the leadership team.

    Responsibilities:

    • Train and develop existing and new CRAs within the business (co-monitoring, report reviews etc)
    • Improve and help develop new monitoring strategies
    • Work in-conjunction with management team.

    Experienced Required:

    • Minimum of 3 years CRA experience which includes training and mentoring of CRAs.
    • Oncology experience strongly preferred
    • CRO or Pharma background

    Please contact Troy Neenan from Skills Alliance on 02072206237 to find out more or click apply.

  • Clinical research

    £40000 - £53000 per annum, bonus
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    A reputable mid-sized Bio-Pharma are seeking an experienced CRA/Lead CRA to join their team to work solely within Inflammation.

    This is a rare opportunity for an experienced clinical research associate to move into a junior study management role with the view to leading global studies within a 12 to 18-month timeframe. You will be responsible for coordinating projects across Europe whilst also overseeing the CRO and other vendors.

    Responsibitliies:

    • Manage small scale studies whilst supporting on global trials.
    • Vendor management
    • Good knowledge of ethics submissions within the UK and across Europe

    Experience required:

    • Minimum of 3 years independent monitoring experience
    • Degree in life sciences or related field
    • CRO or Pharma background

    Please contact Troy Neenan from Skills Alliance on 02072206237 to find out more or click apply.

  • Clinical research

    £50000 - £60000 per annum, bonus
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    A leading cell therapy Biotech are seeking an ambitious Clinical Study Manager to join their team to work in a fast-paced and rewarding environment.

    This is a great opportunity for a scientifically driven individual to move into a hands-on study management role and work closely with senior management. You will be responsible for managing phase II studies whilst also responsible for overseeing external vendors.

    Responsibilities:

    • Manage global studies within a variety of different phases.
    • Manage external vendors for example, data management, CROs etc.
    • Track and manage study budget and timelines.

    Experience required:

    • Minimum 4 years clinical research experience
    • Experience working at study management or junior study management level
    • CRO or Pharma background with strong scientific background preferred.

    Please contact Troy Neenan from Skills Alliance on 02072206237 to find out more or click apply.

  • CRA

    £35000 - £45000 per annum, bonus
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    A reputable diagnostics company are seeking an experienced CRA to join their growing team to work closely with senior management.

    This is a great opportunity to move away from a corporate CRO environment and join a hands on company where you will take on a wide range of responsibilities. There is also the opportunity for quick career progression. You will be responsible for the full life cycle of studies which includes ethics submissions, contract negotiations and interim monitoring.

    Responsibilities:
    • Conduct all types of sites visits.
    • Responsible for ethics submissions and contract negotiations
    • Conduct monitoring reports within an assigned timeframe

    Experience Required:
    • Ideally 1 year plus of medical device experience preferable within in vitro diagnostics
    • Degree in life science or related field
    • CRO or Pharma background

    Please contact Troy Neenan from Skills Alliance on 02072206237 to find out more or click apply.