Senior Director, Program Team Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Take charge of the integrated program strategy for one or more TIL cell therapy assets, spanning from early to late-stage clinical development.

• Integrate clinical, CMC, regulatory, and commercial workstreams into a cohesive plan.

• Lead cross-functional program teams and oversee workstream timelines.

• Convert strategy into actionable execution and collaborate with senior leadership.

• Propel programs through initial clinical studies, pivotal trials, global regulatory submissions, and commercial planning.

• Maintain ownership of program strategy and vision throughout registration and commercialization.

• Formulate strategic options and conduct trade-off analyses for senior leadership and governance bodies.

• Monitor the competitive landscape in solid tumor oncology and cell therapy, translating insights into concrete actions.

• Align subject-matter expert deliverables with development strategy, foresee potential risks, and foster accountability.

• Collaborate with the Program Manager to ensure alignment of domain strategies and execution plans across Clinical, Regulatory, Commercial, and CMC functions.

• Manage program dashboards and report on status, timelines, roadmap progress, inflection points, and risks.

• Act as the primary strategic representative in governance forums and executive reviews.

• Identify issues and propose resolution recommendations to senior leadership.

• Assist with due diligence, business development, and investor-related activities.

• Uphold Iovance Biotherapeutics' values, policies, procedures, and business ethics.

• Carry out miscellaneous duties as assigned.

⛳️ Requirements

• An advanced degree (PhD, PharmD, MD, MBA, or equivalent).

• Over 11 years of experience in clinical drug development.

• Extensive CMC experience in oncology, especially in cell and gene therapy, including CAR-T, viral, and TIL products.

• Familiarity with the global clinical and commercial landscape of oncology and cell therapy.

• Strong strategic and analytical capabilities.

• Proven track record of leading cross-functional teams through various development phases, including regulatory submissions and interactions with health authorities.

• Proficient in program and portfolio management tools with expertise in timeline oversight.

• Ability to influence senior stakeholders and inspire teams without direct authority.

• Comfortable working in a dynamic biotech environment with changing priorities.

• Capability to remain stationary for extended durations.

• Ability to navigate within an office or remote workspace and exert up to 10 pounds of force occasionally.

• Visual acuity for data preparation and analysis, computer screen usage, and extensive reading.

• Repetitive wrist, hand, and/or finger motions.

• Effective communication skills.

• Strong analytical, conceptual, and problem-solving abilities.

• Clear conceptual thinking along with judgment, troubleshooting, analysis, discretion, stress management, prioritization, urgency, and deadline management.

🏝️ Benefits

• Reasonable accommodations may be provided to facilitate individuals in performing job functions.

• Equal-opportunity employer.

• Assistance or accommodations available throughout the application process.