Director, Clinical Science

Director, Clinical Science

The Senior Director, Clinical Science will be a member of the clinical development team, working closely with other members of the medical research group in clinical development to support investigations that deliver the development strategies for therapeutic compounds under development. The Senior Director, Clinical Science contributes to the trial development strategy assisting with protocol development and study design and clinical study execution. In addition, the Senior Director, Clinical Science will contribute to clinical filing activities that are part of new drug applications, which can include activities such as preparing / editing regulatory documents and participating in responses to questions from Regulatory Agencies. The position will report to an Executive Director, Clinical Science / Clinical Research.

Summary of Key Responsibilities :

The Senior Director, Clinical Science will be familiar with drug development, drug mechanism of action, and regulatory requirements and will deploy this expertise in the execution of a number of key responsibilities :

Protocol Development and Trial Planning and Operational Preparation :

• Working with the Medical Director(s), to create key strategic documents including clinical development plans, protocol concepts and full protocols across the 3 phases of clinical development.
• Contribute to the development of clinical sections of regulatory documents such as Investigators' Brochures, briefing books, safety updates, IND / NDA submission documents, responses to Health Authorities questions, and Clinical Development Plans (CDPs).
• Provide ongoing medical expertise and oversight of clinical trials across Phases 1-3 for trial conduct and safety. Provide strategic consultation and guidance to research on all decisions that have significant clinical components and implications.
• Supervise closely all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials.
• Provide essential evaluation of the development strategy to maintain a development plan that is consistent with the latest regulatory requirements, identification of challenges, and development of contingency plans to meet them.
• Provide input into the design and conduct of clinical trials, review and / or generate key study documents (such as medical monitoring and safety management plans, treatment manuals, etc).
• Set up study steering committee to establish relationships with essential opinion leaders relevant to assigned compounds and therapeutic areas, clinical development programs and key clinical studies.
• Assist in the recruitment of investigators for clinical studies and provide medical support to investigator meetings.
• Provide protocol training, disease specific training and presentations at investigator meetings and protocol training meetings.

Trial Execution and Study Management / Study Conduct :

Ongoing Review of Clinical Trial Data and Safety Reviews :

Data Reporting and Preparation of Study Documents :

Medical and Scientific Expertise / Support :

Requirements :

5,000 patients) global, multinational cardiovascular outcomes trials.

About Alnylam :

Alnylam Pharmaceuticals (Nasdaq : ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture :

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