Program Lead, Development - Rare Disease
About The Position
The Senior/Executive Director, Development Program Lead provides strategic and operational leadership for two early-stage rare disease programs in the hepatobiliary space. The role is accountable for building integrated development strategies and leading execution through critical early clinical milestones. The Program Lead guides cross-functional teams in setting priorities, anticipating program needs, and making investment decisions informed by emerging clinical and scientific evidence. The position requires an experienced drug development leader who can work effectively in ambiguity, clarify important milestones, and sustain engagement across programs. The successful candidate brings rare disease and early development experience and can integrate diverse perspectives and influence stakeholders across functions and organizational levels. The Program Lead collaborates with Research, Early Development, Clinical Research, Clinical Operations, Regulatory Affairs, Biostatistics, Drug Safety, Medical Affairs, Manufacturing, Quality, Program Management, Clinical Supply, Commercial, and Finance. The role is hybrid based at Alnylam’s Cambridge, Massachusetts office, with consideration for U.S.-remote candidates who have exceptional applicable experience.
Requirements
- Advanced degree in medicine, science, pharmacy, or a related discipline; MD, PhD, PharmD, or equivalent advanced scientific or clinical training is preferred.
- 10+ years of progressively responsible experience in biotechnology or pharmaceutical drug development, including significant experience leading cross-functional development teams or complex development programs.
- Broad understanding of drug development and interdependencies among clinical development, regulatory strategy, clinical operations, safety, biometrics, nonclinical development, CMC, and program management.
- Experience developing integrated program strategies, evaluating development scenarios, and translating scientific and clinical evidence into program decisions.
- Ability to rapidly build sufficient knowledge to lead programs in complex or evolving disease areas.
- Demonstrated ability to lead through influence, align stakeholders with differing perspectives, and drive decisions without relying on formal authority.
- Ability to navigate ambiguity, identify important decisions and milestones, and create clarity for cross-functional teams.
- Strong strategic judgment and willingness to work at a detailed, hands-on level when required.
- Ability to anticipate development needs and plan for program success while balancing evidence, risk, resources, and organizational priorities.
- Strong executive presence and ability to communicate complex program considerations clearly and persuasively to senior leaders and governance forums.
- Collaborative, decisive, and adaptable leadership style with a commitment to data-driven decision-making.
- Demonstrated commitment to patients, scientific rigor, integrity, accountability, and high performance.
- Clear alignment with Alnylam’s Core Values: Fiercely Innovative, Open Culture, Passion for Excellence, Purposeful Urgency, and Commitment to People.
Nice To Haves
- Demonstrated experience in rare disease drug development.
- Meaningful early-stage development experience, including first-in-human studies, Phase 1 development, proof-of-concept planning, and/or progression into Phase 2.
- MD, PhD, PharmD, or equivalent advanced scientific or clinical training.
- Exceptional applicable experience for consideration as a U.S.-remote candidate.
Responsibilities
- Lead the development and execution of integrated, cross-functional strategies for early-stage rare disease programs.
- Establish program vision, strategy, and prioritized milestones aligned with scientific, clinical, regulatory, operational, and business considerations.
- Develop fit-for-purpose program plans based on each asset’s stage, evidence base, investment level, and future potential, while remaining ready to accelerate development if emerging data support it.
- Lead cross-functional teams in defining proof-of-concept strategies, decision criteria, critical assumptions, and data requirements to evaluate therapeutic potential and inform investment decisions.
- Integrate scientific evidence, clinical data, regulatory considerations, patient needs, and the external landscape into program strategy and decisions.
- Translate complex or incomplete information into clear recommendations, priorities, and executable plans.
- Anticipate program risks, barriers, and interdependencies; establish mitigation and contingency plans and escalate issues as appropriate.
- Partner with functional leaders to align resources, capabilities, and subject-matter expertise with program milestones and deliverables.
- Foster an inclusive, high-performing team environment that encourages rigorous debate, transparent communication, shared accountability, and timely decisions.
- Prepare and present program strategy, status, risks, scenarios, and recommendations to governance bodies and senior leadership.
- Ensure key decisions, assumptions, dependencies, and program risks are documented and communicated across the organization.
- Champion the programs and articulate their scientific rationale, patient impact, strategic value, and development path.
Benefits
- Annual short-term incentive award, such as a bonus or sales incentive.
- Annual long-term incentive award, such as equity.
- Medical coverage.
- Dental coverage.
- Vision coverage.
- Life insurance.
- Disability insurance.
- Lifestyle reimbursement program.
- Flexible spending and health savings accounts.
- 401(k) with a generous company match.
- Paid time off.
- Wellness days.
- Holidays.
- Two company-wide recharge breaks.
- Family resources and leave.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
