Senior Clinical Scientist

Talent Acquisition Partner: Jeannine Ripley

Hiring Manager: Monika Miranda

Overview  

Alnylam Pharmaceuticals is seeking an imaginative clinical scientist drug developer for the role of Senior Clinical Scientist. This is an opproutnity to assume a foundational and strategic role in the building Alnylam's rapidly expanding portfolio of transformtative, RNAi-based medicines. 

The successful candidate will work closely with one or more clinical development teams of physicians and clinical scientists, whose primary role will be to serve as a clinical research expert in one or more of its global early- through late-phase clinical development programs. In addition, he/she/they will be expected to support the scientific integrity and quality of their assigned clinical trials.

Working within a matrixed environment, the Senior Clinical Scientist will be a cross- functional influencer in the maturation of the global product development plan, including the clinical development plan, clinical trial design, study protocol, and clinical study execution. He/she/they will also be a contributor to correspondence with health authorities/regulatory agencies (IND, NDA, label negotiations, etc) and participate in the navigation of strategic partnerships, patient advocacy alliances, advisory boards, and a network of external consultants and experts. He/she/they may also work with Alnylam’s research and discovery group to evaluate the development feasibility of novel targets in early phase clinical development programs. In addition, he/she/they will be expected to be an Alnylam R&D spokesperson at external meetings, including health authorities and at scientific meetings, as well as being an emerging influencer of the evolving science supporting the clinical research in the assigned program indications.

Summary of Key Responsibilities

The Senior Clinical Scientist will be fully conversant with the fundamental stages and principles of drug development, the principles of pharmacologic action, the design and execution of well-controlled clinical trials, and the fulfillment of regulatory requirements while observing Good Clinical Practice (GCP); and will apply this expertise within a matrixed clinical research and development setting, to include the following:

 Work with the Therapeutic Area Head as well as Medical Director(s), to create key strategic documents, including the clinical development plan, protocol concept and full protocol for one or more products in early-stage development, while also contributing to product(s) in later stages of development, including NDA filings

  Contribute to the key documents describing products in development, such as the Investigators’ Brochure and safety updates

  Contribute to correspondence with the health authorities approached by the assigned programs, such as the briefing book, IND, NDA, as well as responses to health authority questions

• Develop a working knowledge of the operational characteristics of the clinical endpoints relevant to the assigned clinical trial indication, the study population represented by various inclusion/exclusion criteria or diagnoses, and their use in previous clinical trials, to enable informed and innovative clinical trial design

 Develop a working knowledge of the clinical scales and patient reported outcome tools associated with the assigned clinical trial indication to facilitate their qualification and justification for regulatory correspondence and study start up activities

  Develop a working knowledge of the biomarkers and other measured endpoints associated with the assigned clinical programs, their assay characteristics, sample handling requirements, and qualification needs, if any

  Monitor regulatory policies and guidance to ensure scientific quality/innovation

of clinical study design, execution, reporting and publication

 Ensure that all studies observe the highest standards of ethical and safe conduct, and ensure compliance with GCP; monitor study progress and perform medical data review for endpoint and safety management to ensure integrity of study data

  Develop effective working relationships with investigators in assigned programs

 Plan, participate in key external facing meetings such as investigators meetings, protocol training meetings, safety review meetings, developing study presentations, handouts, and coordination of Investigator Meetings, Advisory Boards, Study Monitoring Committees throughout the life cycle of a program

  Analyze and interpret study data from an individual study; translate study level clinical data across the program of studies for a particular drug

 Facilitate the awareness of the real-time availability of clinical trial data (including safety, efficacy, pharmacokinetic and biomarker data), to provide consolidated information for dose escalation meetings, data safety monitoring boards, and interim analyses

 Assist Clinical Operations in developing clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties

Qualifications

• Minimum of a college degree in life sciences or nursing degree, advanced degree preferred (i.e. MD, PhD, PharmD or MS)

• Minimum of 5 years of experience in clinical research or equivalent
• Clinical trial/drug development Phase 1-3 expertise highly desirable
• The skills required for success in the job include scientific and analytic ability, ability to think strategically and tactically, an interest in applied clinical research, ability to work effectively in multifunctional and multinational teams, as well as the ability to multitask and prioritize.

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U.S. Pay Range

$155,300.00 - $210,100.00

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of Nebula.