Clinical Scientist

Alnylam Pharmaceuticals is seeking an imaginative clinical scientist drug developer for the role of Clinical Scientist. This is an opportunity to assume a foundational and strategic role in building Alnylam's rapidly expanding portfolio of transformative, 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 scientic integrity and quality of their assigned clinical trials.

Working within a matrixed environment, the Clinical Scientist will be a cross- functional inuencer 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 scientic meetings, as well as being an emerging inuencer of the evolving science supporting the clinical research in the assigned program indications.

Key Responsibilities

The 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 fulllment 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, while also contributing to NDA lings

* Contribute to the key documents describing products in development, such as the Investigators' Brochure, DSUR, PSUR and safety updates

* Contribute to correspondence with the health authorities approached by the assigned programs, such as the brieng 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 in order to facilitate their qualication and justication 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 qualication needs, if any

* Monitor regulatory policies and guidance to ensure scientic quality/innovationof 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 to ensure integrity of study data and appropriate safety follow-up

* Develop effective working relationships with investigators in assigned programs Plan and participate in investigators meetings and protocol training meetings

* Prepare and run dose escalation meetings with investigators (phase 1)

* Lead or contribute to trial-related advisory boards

* 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

* Set up and manage investigator initiated clinical and/or pre-clinical trials

* Assist Clinical Operations in developing clinical outsourcing specications to facilitate bid templates and selection of CROs and other 3rd parties, as needed

Qualications

* Master's Degree, PhD, PharmD, or M.D. preferably with a clinical research background, or clinical trial/drug development experiences at various phases of development (Phase 1-3)

* Industry experience (2+ years) in R&D preferably focused on rare diseases

* Working knowledge of the concepts of global clinical development, clinical research, and clinical trial design, including biostatistics, dose selection, clinical endpoint validation, product proles and target labels, and global regulatory agency processes

* Professional history of solving problems and navigating uncertainty while exhibiting superior judgement and a balanced, realistic understanding of competing issues and priorities

* Professional history that includes a track record of collaboration skill in working within a matrix environment

* Professional history that includes a successful track record of preparing and conveying complex medical/clinical concepts in both written and oral communication

* Professional history that demonstates scientic and analytic ability, ability to think strategically and tactically, ability to work effectively in multifunctional and multinational teams, as well as the ability to multitask and prioritize

* Professional history that demonstrates the ability to initiate and cultivate productive relationships with investigators, scientists, and patient advocates

U.S. Pay Range

$146,200.00 - $197,800.00

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 the Careers website: https://www.alnylam.com/careers

AboutAlnylam

We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.