Sr. Director, Clinical Research

Alnylam Pharmaceuticals; Cambridge (MA); Hybrid; USD 306,000 - 414,000; Full time

Benefits offered by this job

Medical benefits

401(k) matching

Paid time off

Wellness days

Job summary

Alnylam Pharmaceuticals in Cambridge, MA is seeking an imaginative physician drug developer to lead early clinical research in CVM with a kidney focus, combining scientific leadership with practical execution of first-in-human and proof-of-concept studies. The Sr.

Medical Director will collaborate across Regulatory, Biostatistics, Clinical Operations and Medical Affairs, oversee trial conduct, and represent Alnylam at external meetings, reporting to the Sr.

Qualifications

• MD or MD PhD with Board Certification or nephrology specialization preferred.
• 5+ years industry experience leading early phase CVM/renal programs, including trial design and regulatory interactions.
• Ability to develop strategic clinical development plans and navigate governance for approvals.

Responsibilities

• Be the strategic clinical leader for programs in CVM and kidney disease.
• Lead design and execution of first-in-human and proof-of-concept trials.
• Oversee trial conduct and safety; collaborate across Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial & QA.
• Serve as early clinical research lead on CDST/ECs and drive Clinical Development Plans.

Skills

Leadership

Clinical development

Regulatory interactions

Medical monitoring

Scientific judgment

Education

MD/MD PhD

Board Certification / Nephrology specialization

Job description

Alnylam Pharmaceuticals is seeking an imaginative physician drug developer in Clinical Research - Cardiovascular & Metabolism (CVM) therapeutic area, also with the flexibility and confidence to work in therapeutic areas that may be beyond their expertise or experience. This is an opportunity to provide clinical leadership in developing RNAi therapeutics in Alnylam's rapidly expanding CVM portfolio, which spans a number of disease areas including kidney disease.

The successful candidate's primary role will be the early clinical research lead for multiple early-stage first-in-class kidney programs in CVM therapeutic area. The Sr. Medical Director, Clinical Research is expected to play a leading and influencing role in the overall clinical development strategies for the programs and to drive progress and operational excellence for the associated clinical trials.

In addition, this role will include significant interaction with Alnylam's research group, helping to advise the team on the clinical development feasibility of novel kidney targets and the design of proof-of-concept studies. This work will also involve extensive consultation and collaboration with external experts.

The Sr. Medical Director, Clinical Research will work in a matrix organization across Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial & QA teams to ensure fully harmonized and integrated development strategies. This role will be a key Alnylam Development spokesperson at external meetings, including regulatory interactions and scientific meetings. The role will report to the Sr. Vice President, CVM Clinical Research Therapeutic Area head.

This position is hybrid and will be primarily located at our Cambridge, MA headquarters

Key Responsibilities

• Be the strategic leader providing a strong, clear voice for clinical programs.
• Develop creative but realistic approaches to drug development and lead clinical efforts to secure first-in-human and proof-of-concept milestones.
• Oversight of trial conduct and safety.
• Serve as early clinical research lead on ePT (Early Project Team) or chair of CDST (Clinical Development Sub-Team) depending on the stages of programs, with accountability for the Clinical Development Plan.
• Provide strategic consultation and guidance to Research on all decisions that have significant clinical components and implications.
• Collaborate closely with Preclinical, Translational Research, Regulatory Affairs and Medical Affairs to ensure tight strategic integration of product development plans.
• Be accountable via Clinical Research and Clinical Operations for all relevant timelines and deliverables.
• Contribute to and/or closely supervise (as relevant) all major written deliverables (protocols, IBs, informed consent forms, briefing documents, regulatory submissions, original articles, abstracts) and presentation materials.
• Influence internal and external audiences in a high impact, highly visible fashion.

Qualifications

• MD or MD PhD, Board Certification (or equivalent) or specialist training in Nephrology is preferred
• 5+ years industry experience with early phase clinical program leadership experience in CVM or renal drug development, including leading trial design and execution and successful regulatory interactions
• Ability to develop state-of-the-art CDPs and to navigate through internal governance boards in securing strategic approval of CDPs as well as resource planning and assignment
• Strong medical monitoring skills
• Sound scientific and clinical judgment

U.S. Pay Range

$305,700.00 - $413,700.00

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.

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.