Project Manager - Drug Development | IntelliPro
Overview
Own the execution of the Diranersen program, a high-stakes Alzheimer's disease asset advancing toward Phase 3. Drive integrated program planning across clinical, regulatory, and commercial functions, enabling the PDC Lead to focus on strategy. Bridge cross-functional teams, manage governance, and embed patient-centric insights into every milestone. This role demands a hands-on leader who thrives in a matrixed environment and delivers results without direct authority.
What You'll Do10
- 1Translate asset strategy into an actionable integrated program plan, aligning clinical, regulatory, medical, access, and commercial functions.
- 2Drive scenario planning and trade-off analyses to support key strategic decisions, integrating external competitive and regulatory insights.
- 3Coordinate across Clinical Development, Regulatory Affairs, Medical, Market Access, and CMC/Supply to ensure clear accountability and milestone delivery.
- 4Lead preparation of the DASP and communications for external milestones, PR, and earnings.
- 5Oversee device integration to keep critical workstreams connected to asset strategy.
- 6Proactively identify and resolve cross-functional gaps or misalignments to maintain program momentum.
- 7Own the integrated development and operating plan, including timelines, critical path, milestones, and budget assumptions.
- 8Track performance and drive on-time, high-quality execution while leading risk management through identification and mitigation.
- 9Lead program governance with the PDC Lead, structuring decision frameworks and maintaining decision logs and action tracking.
- 10Embed patient-centric thinking by integrating insights from advocacy groups, key opinion leaders, and clinical experts.
Requirements8
- 110+ years in drug development and commercialization with exceptional business acumen.
- 2Demonstrated strong analytical and leadership skills, including a creative, problem-solving mindset.
- 3Ability to rapidly identify key priorities, align strategic and tactical plans, and influence cross-functional teams.
- 4Outstanding relationship building and communication skills, including ability to navigate at all levels.
- 5Experience establishing and managing external collaborations, including familiarity with contractual and compliance considerations.
- 6Very strong project leadership (scoping project goals, stakeholder planning) and project management skills.
- 7Prior experience in a Product Development & Commercialization organization, Global Medicines Development, or cross-functional R&D/commercial team preferred.
- 8Neuroscience and launch preparation experience a plus.
Salary Insight
Salary not disclosed in listing
Location
Required Skills
Similar open positions
Explore active roles that match your skills and interests.
Neurocrine Biosciences Inc.
VerifiedPrincipal Scientist Pharmaceutical Development Neurocrine Biosciences
Neurocrine Biosciences seeks a senior technical leader to drive CMC projects from discovery through commercialization. This role provides strategic scientific leadership in process development and manufacturability while collaborating with internal and external partners. The ideal candidate excels in parenteral drug product development and has extensive experience with regulatory compliance and cross-functional teamwork.
Organon
VerifiedDirector Nonclinical Development Organon
Lead nonclinical subject matter expertise for Women’s Health General Medicines and Biosimilars programs. Reports to Executive Director and collaborates with clinical regulatory safety pharmacovigilance chemistry manufacturing and business development. Serves as nonclinical representative on asset development teams and supports regulatory submissions.
6062-Janssen Pharmaceuticals, Inc. Legal Entity
VerifiedGroup Product Director Neuroscience Schizophrenia
The Group Product Director (GPD) leads U.S. HCP marketing strategy and professional education for long-acting injectables and CAPLYTA brand. This hybrid role reports to the Director of Marketing Neuroscience Schizophrenia. The leader drives inclusive culture and cross-functional collaboration.
Gilead Sciences
VerifiedExecutive Director Clinical Data Engineering & Analytics
Strategic leader delivering modernization of programming support through SDTM for clinical pharmacology and biomarker studies. Oversees global teams and drives AI-readiness while ensuring regulatory compliance and data governance excellence.
1010 Gilead Sciences, Inc.
VerifiedExecutive Director Asset Team Leader Inflammation
Lead the cross-functional asset team for immunology programs, shaping strategy from early development through commercialization. Drive asset vision, lifecycle planning, and enterprise-level decisions across multiple indications. Report jointly to Commercial and Development Therapeutic Area Heads, and serve as the primary liaison to senior leadership. This role demands expertise in navigating complexity and delivering high-impact outcomes.
1010 Gilead Sciences, Inc.
VerifiedSenior Scientist Drug Metabolism
Lead advanced PK and PK/PD modeling expertise across discovery and development stages. Drive quantitative DMPK strategy and collaborate with interdisciplinary teams to integrate modeling approaches. Design and validate complex PK/PD and mechanistic models to support dose selection and predict first-in-human exposures. Develop AI-enhanced modeling workflows and partner with CROs to ensure high-quality regulatory submissions. Shape business development and licensing evaluations while participating in cross-functional projects. This role differs by focusing on leadership in culture and driving innovation across scientific domains.