Director, Clinical Research

About the role

The Director, Clinical Research, will work in a matrix organization across Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial & Quality Assurance teams to ensure fully harmonized and integrated development strategies. He/she will be a key Alnylam Development spokesperson at external meetings, including regulatory interactions and scientific meetings.

Responsibilities

• Be the strategic leader providing a strong, clear voice for the clinical program.
• Develop creative but realistic approaches to drug development and lead clinical efforts to secure global regulatory approvals.
• Oversight of trial conduct and safety.
• Provide strategic consultation and guidance to Research on all decisions that have significant clinical components and implications.
• Collaborate closely with Preclinical, Regulatory Affairs and Medical Affairs to ensure tight strategic integration of product development plans.
• Be accountable via Clinical Research and Operations for all relevant timelines and deliverables.
• Supervise closely all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials.
• Be responsible for final review and sign off with respect to all controlled documents including protocols, investigator brochures, and informed consent forms.
• Influence internal and external audiences in a high impact, highly visible fashion.

Qualifications

• A highly driven, dynamic, engaged and accomplished physician-scientist with experience and insight will thrive in this role.
• MD with strong research background or MD PhD with best of class clinical and/or research training as shown through research support and peer-reviewed publications.
• Board Certification (or equivalent) or specialist training in cardiology.
• Expertise in heart failure and/or amyloidosis is desirable.
• 3+ years industry experience or equivalent clinical academic experience.
• Sound scientific and clinical judgment.
• Familiarity with concepts of clinical research and clinical trial design, including biostatistics, and regulatory agency organization, guidelines, and practices.
• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication.
• History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues.
• Outstanding leadership and collaboration skills working within a matrix environment.
• Experience and knowledge of working with biotech/pharma partner(s).
• Thrives in highly entrepreneurial biotech environment and embraces Alnylam’s culture of science, passion and urgency.

Pay

$255,000.00 - $345,000.00

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.