Director, Clinical Science

Overview

The 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 (medical lead, medical monitor, statistician, medical safety director, safety manager and clinical pharmacologist) to support investigations that deliver the development strategies for therapeutic compound(s) under development. The Director, Clinical Science contributes to the trial development strategy assisting with protocol development and study design and clinical study execution. In addition, the 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 a Senior Director, Clinical Science / Clinical Research.

Summary of Key Responsibilities :

The 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.

U.S. Pay Range

$199,800.00 - $270,300.00

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.