Skyhawk Therapeutics is committed to pay transparency and equitable compensation practices. The base salary range for the Clinical Project Manager is $170,000-250,000 annually. This range reflects the minimum and maximum target for such position. Skyhawk Therapeutics will assess the appropriate level for a qualified candidate based on job-related skills, professional experience, and relevant education or training.
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Associate Director/Director, Commercial Project Management
Waltham, MA
Associate Director/Director, Commercial Project Management
Skyhawk Therapeutics is seeking a highly motivated and experienced Associate Director, Commercial Project Management to lead cross-functional planning and execution for the launch of SKY-0515 — a potential first-in-class, disease-modifying therapy for Huntington's disease. This is a rare opportunity to play a central, high-visibility role in shaping and delivering one of the most anticipated launches in rare neurological disease.
Reporting to senior commercial leadership, the Associate Director will serve as the central coordinator and integrator across clinical, regulatory, medical affairs, market access, and commercial teams — driving launch readiness with rigor, urgency, and strategic clarity.
Responsibilities (including, but not limited to):
Launch Planning & Execution
- Develop, own, and manage the integrated launch plan including timelines, milestones, workstream interdependencies, and critical path to regulatory approval and commercialization
- Define and continuously refine the critical path to NDA/regulatory submission and commercial launch across all functional workstreams.
- Lead launch readiness reviews and go/no-go decision frameworks, ensuring senior leadership has timely, accurate, and actionable information.
- Develop and maintain executive- and board-level launch dashboards and status reporting that distill complexity into clear progress narratives.
- Proactively identify risks to launch timelines and readiness; develop contingency plans and adapt as new data, regulatory feedback, or business priorities emerge.
Cross-Functional Coordination
- Ensure strategic and operational alignment across regulatory, clinical, CMC, medical affairs, market access, commercial, and finance workstreams.
- Lead and facilitate launch team working groups; maintain accountability for key decisions, next steps, and action items.
- Partner with Medical Affairs on publication planning, congress strategy, and scientific communication platform execution.
- Coordinate HCP field force readiness activities, including training timelines, materials development, and deployment planning.
- Support payer and market access workstream planning, including reimbursement strategy milestones and patient services infrastructure.
- Manage external vendors, consultants, and agency partners engaged in commercial launch readiness.
Project Management Infrastructure
- Build, maintain, and continuously improve core project management tools and systems (e.g., Smartsheet, Monday.com, Asana).
- Oversee launch budget tracking and resource planning in close coordination with Finance.
- Establish best-in-class PM processes appropriate for a fast-moving, resource-efficient small company environment.
Education / Skills / Experience Required:
Required
- Bachelor's degree required; advanced degree (MBA, MS, or equivalent) strongly preferred.
- 8–10+ years of experience in the biotech or pharmaceutical industry, with demonstrated progression in responsibility.
- Meaningful experience in late-stage development and/or commercial launch, including parallel NDA/BLA submission and launch preparation.
- Proven track record leading complex, cross-functional projects in matrixed environments with multiple senior stakeholders.
- Exceptional project management and organizational skills — able to manage multiple workstreams simultaneously without losing detail or momentum.
- Strong executive communication and presentation skills — ability to synthesize complexity and present clearly to senior leadership and board audiences
- Comfort and effectiveness operating in fast-paced, evolving, small-company settings where ambiguity is the norm and ownership is expected.
Preferred
- Experience in Huntington's disease, neurology, CNS, or rare/specialty disease strongly preferred.
- Familiarity with FDA rare disease regulatory pathways including Breakthrough Therapy Designation, Orphan Drug Designation, and accelerated approval mechanisms.
- Experience with international regulatory submissions and ex-US launch coordination (e.g., EMA, TGA).
- Proficiency across project management platforms (Smartsheet, Monday.com, Asana, Veeva, or equivalent).
- Prior experience at a company navigating first commercial launch.
About Skyhawk
Skyhawk is committed to discovering, developing and commercializing small molecule therapeutics that modify RNA expression. We use our novel SkySTAR® platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the world’s most intractable diseases including neurological conditions, cancer, and traditionally “undruggable” targets.
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