Medical Director, Clinical Research

Alnylam Pharmaceuticals; Cambridge (MA); Hybrid; USD 255,000 - 345,000; Full time

Job summary

Alnylam Pharmaceuticals seeks an imaginative physician drug developer to lead the clinical program for RNAi therapeutics. You will guide trial design, safety oversight, and regulatory strategy across an expanding portfolio, reporting to the program medical lead in a matrix organization.

The role emphasizes strategic leadership, collaboration with Regulatory, Preclinical, Medical Affairs, and external experts, and interaction with external meetings and regulatory bodies.

Qualifications

• 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) in cardiology or specialist training
• Expertise in heart failure and/or amyloidosis is desirable
• 3+ years industry experience or equivalent clinical academic experience
• Strong clinical and scientific judgment in design of clinical research and regulatory processes
• Ability to present ideas clearly in writing and orally
• Experience in biotech/pharma collaborations and matrix environments

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 decisions with clinical impact
• Collaborate with Preclinical, Regulatory Affairs and Medical Affairs for integrated development plans
• Be accountable for timelines and deliverables in Clinical Research and Operations
• Supervise major written deliverables and presentation materials
• Final review of protocols, investigator brochures, and informed consent forms
• Influence internal and external audiences in a high visibility role

Skills

Clinical leadership

Regulatory strategy

Trial design

Biostatistics

Cross-functional collaboration

Education

MD/MD-PhD with clinical/research

Board Certification in Cardiology

Tools

Regulatory affairs

Clinical operations

Job description

Overview

Alnylam Pharmaceuticals is seeking an imaginative physician drug developer, with the flexibility and confidence to work in therapeutic areas that may be beyond their particular expertise or experience. This is an opportunity to provide clinical leadership in developing RNAi therapeutics in Alnylam's rapidly expanding portfolio, which spans from rare genetic to common diseases.

The successful candidate's primary role will be as one of the clinical leads in a clinical development program in ATTR amyloidosis. He/she will report directly into the program medical lead who provides the clinical research oversight of the program. He/she is expected to play a leading and influencing role in the overall clinical development strategies for the molecules and drive progress and operational excellence for associated clinical trials. In addition, this role will include interaction with Alnylam's research group, helping to advise the team on the clinical development feasibility of novel targets and the design of proof-of-concept studies. This work will also involve extensive consultation and collaboration with external experts. It is anticipated that additional opportunities will arise to lead bench-to-bedside early phase clinical development programs. 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.

*This a hybrid position with 2 days a week onsite presence in our Cambridge, MA or Philadelphia, PA office required.

Key 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. Specific qualifications include:
• 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 judgmentFamiliarity 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.

About Alnylam

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.

Before applying, please review Alnylam's CandidatePrivacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.

The pay range below 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

U.S. Pay Range $255,000—$345,000 USD