Program Leader, Diranersen PDC
Listed on 2026-06-23
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Management
Regulatory Compliance Specialist, Program / Project Manager, Operations Management, Change Management
Description
Hybrid 2-3 days onsite in Cambridge, MA
Our client seeks a hands‑on program leader to drive cross‑functional execution for the Diranersen program as it advances toward Phase 3 protocol development. The role partners with the PDC Lead to convert asset strategy into an integrated plan, align clinical, regulatory, medical, access, commercial, and CMC/Supply functions, and manage governance, risk, timelines, and budgets. The leader will embed patient‑centric insights, integrate competitive and regulatory landscapes, and operate as a connector across a global matrix to maintain momentum and enable high‑quality delivery.
We can facilitate w2 and corp‑to‑corp consultants. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.
Rate: $103.85 to $124.62/hr. w2
JN -
Responsibilities- Partner with the PDC Lead to translate asset strategy into an actionable, integrated program plan that aligns clinical, regulatory, medical, access, and commercial functions.
- Drive scenario planning and trade‑off analyses for key strategic decisions and integrate external landscape insights, including competition, regulatory evolution, and advocacy.
- Lead coordination across Clinical Development, Regulatory Affairs, Medical and Patient Engagement, Market Access and Commercial, and CMC/Supply to ensure accountability and milestone delivery.
- Prepare the DASP and lead communications planning for external milestones, PR and earnings preparation, and internal communications.
- Provide oversight of device integration to ensure alignment with overall asset strategy and execution.
- Identify and resolve cross‑functional gaps or misalignments and maintain program momentum.
- Own the integrated development and operating plan with timelines, critical path, milestones, deliverables, and resource and budget assumptions.
- Track performance, drive on‑time, high‑quality execution, and lead risk identification, mitigation, and escalation.
- Lead program governance with the PDC Lead, including preparing PDC and sub‑team forums, structuring decision frameworks, and maintaining decision and action logs.
- Operate as a central connector across a global matrix and influence senior stakeholders across R&D and Commercial without direct authority.
- Foster a high‑performing, accountable, and collaborative team environment with clear roles, decision rights, and ways of working.
- Embed patient‑centric thinking by integrating insights from advocacy groups, key opinion leaders, and clinical experts with focus on Alzheimer’s Disease.
- 5+ years of drug development and commercialization experience with strong business acumen and general management perspective.
- Demonstrated analytical and leadership skills with a problem‑solving mindset.
- Ability to identify priorities, align strategic and tactical plans, and influence and motivate cross‑functional teams.
- Strong relationship building and communication skills with the ability to navigate all organizational levels.
- Experience establishing and managing external collaborations, including contractual, financial, and compliance considerations.
- Strong project leadership and project management skills.
- Preferred experience within Product Development & Commercialization, Global Medicines Development, or cross‑functional R&D/commercial teams; neuroscience and launch preparation experience are a plus.
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