Senior Clinical Scientist

Talent Acquisition Partner:
Jeannine Ripley Hiring Manager:
Monika Miranda

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 scientic integrity and quality of their assigned clinical trials.

Working within a matrixed environment, the Senior 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.

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 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 in early-stage development, while also contributing to product(s) in later stages of development, including NDA lings
• 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 brieng book, IND, NDA, as well as responses to health authority questions
• Develop a working knowledge of the operational characteristics of the clinical endpoint s relevant to the assigned clinical trial indication, the study population represented by various inclus ion/e 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 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/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…