Associate Director/Director, Clinical Program Management

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

📋 Description

• Create and execute development plans that span across functions at both strategic and tactical levels.

• Grasp the functional interfaces and promote alignment among different functions to reach corporate goals.

• Effectively escalate risks to senior management and devise and implement strategies for mitigation.

• Plan with a future-oriented approach to evaluate the commercial viability throughout the product's life cycle.

• Organize regular meetings for teams and cross-functional collaboration.

• Design dashboards and provide status reports to senior management.

• Support budgeting efforts and monitor study and operational budgets to ensure optimal resource allocation across projects.

• Keep track of changing regulatory requirements and quality trends across different modalities.

• Ensure preparedness and proactive compliance planning.

• Co-manage the planning, execution, and completion of clinical trials for the L606 and Yutrepia programs.

• Work together with internal and external stakeholders across Operations, Product Development, Clinical Operations, Regulatory, Medical Affairs, Commercial, and vendors.

• Oversee vendor relationships, development schedules, and budget timelines.

⛳️ Requirements

• Bachelor’s degree and at least 8 years of pertinent experience with an emphasis on matrix management.

• An advanced degree (MS, PhD, MBA) in a relevant biopharmaceutical field is preferred.

• Experience in program management from IND to NDA/BLA and global launch, including knowledge of global registration processes.

• Preferred experience with Phase 4 studies.

• Background in the biotech/pharmaceutical sector.

• Proven understanding of cross-functional dependencies across R&D, commercial, technical development, and regulatory aspects.

• Experience in managing integrated timelines, critical paths, resource limitations, and dependencies across concurrent development programs.

• Capability to lead, inspire, and influence others without direct authority.

• Ability to harness and cultivate diverse perspectives and ideas from matrix teams.

• Exceptional communication, negotiation, problem-solving, and decision-making skills.

• Proficiency in developing forecasts, assessing resource variances, and communicating risks.

• Skill in establishing decision logs, ownership, escalation processes, and ensuring follow-through across matrix teams.

• Competence in identifying critical program risks and creating mitigation plans.

• Strong preference for experience supporting combination device programs, inhaled technologies, and/or small molecules.

• Demonstrated experience managing complexity in global programs across various modalities.

• Proficiency with project management and reporting tools, such as Smartsheet.

• PMP or equivalent project/program management training is preferred.

🏝️ Benefits

• Competitive compensation package.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Short-term disability (STD).

• Long-term disability (LTD).

• 401(k) Savings Retirement Plan.

• Employee Stock Purchase Plan (ESPP).

• Equal opportunity employment.

• Reasonable accommodations for qualified individuals with disabilities.