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Clinical Program Leader
Location
United States
Posted
4 days ago
Salary
Not specified
No structured requirement data.
Job Description
Role Description
The Clinical Program Leader (CPL) is a core member of the cross-functional R&D Global Core Team, playing a pivotal role in shaping the global clinical strategy and development for their assigned program. They ensure scientific and medical integrity in the development and execution of clinical studies, leading clinical input into regulatory submissions and interactions. This role requires strong scientific acumen, matrix team leadership, and strategic vision to drive the successful development and commercialization of innovative therapies in alignment with patient needs and global regulatory standards.
- Leads the strategic planning and high-quality execution of clinical development programs, ensuring scientific rigor and alignment with regulatory and business objectives.
- Provides clinical leadership within the Core Team, ensuring the clinical perspective informs key strategic decisions.
- Leads the Clinical Team in designing and executing a comprehensive global clinical development strategy from Phase 1 through Phase 4, optimizing study design and execution.
- Provides clinical oversight of the design, implementation and operational delivery of clinical studies from early to late-stage drug development.
- Provides medical and scientific leadership to cross-functional teams, driving internal disease awareness and enhancing knowledge of the product landscape.
- Represents the company and clinical program in regulatory authority interactions, governance meetings and external partnerships.
- Engages with external experts and key stakeholders to drive data-driven decision-making by interpreting clinical trial results and integrating findings into program strategy.
- Engages with regulatory authorities, external experts, and key stakeholders to shape development plans and ensure compliance with global regulatory requirements.
- Fosters innovation and continuous improvement in clinical trial design and execution to enhance patient outcomes and program efficiency.
Qualifications
- Medical Doctor Degree from a renowned institution.
- Significant experience in designing and executing a comprehensive clinical research & development plan.
- At least 5 years in an R&D role in the pharmaceutical/biotech industry, or 7-10 years in academia with clinical investigator track record.
- Outstanding communication skills with ability to interact with and influence internal stakeholders and external academic and regulatory experts.
- Strong understanding of GCP, regulatory requirements, and clinical trial methodologies.
- Ability to interpret and effectively communicate complex clinical and scientific data, and literature.
- Ability to successfully manage multiple tasks and resources concurrently while maintaining high attention to detail and responding to rapidly changing priorities.
Requirements
- Experience in development of protocols, reports and preparation of global clinical development plans, as well as authoring clinical sections of regulatory documentation.
Benefits
- Comprehensive healthcare programs.
- Work-life balance initiatives.
- Robust relocation support.
- Competitive salary package, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market.
- Flexible working arrangements and remote work options.
- Tax assistance services for foreign colleagues.
Job Requirements
- Medical Doctor Degree from a renowned institution.
- Significant experience in designing and executing a comprehensive clinical research & development plan.
- At least 5 years in an R&D role in the pharmaceutical/biotech industry, or 7-10 years in academia with clinical investigator track record.
- Outstanding communication skills with ability to interact with and influence internal stakeholders and external academic and regulatory experts.
- Strong understanding of GCP, regulatory requirements, and clinical trial methodologies.
- Ability to interpret and effectively communicate complex clinical and scientific data, and literature.
- Ability to successfully manage multiple tasks and resources concurrently while maintaining high attention to detail and responding to rapidly changing priorities.
- Experience in development of protocols, reports and preparation of global clinical development plans, as well as authoring clinical sections of regulatory documentation.
Benefits
- Comprehensive healthcare programs.
- Work-life balance initiatives.
- Robust relocation support.
- Competitive salary package, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market.
- Flexible working arrangements and remote work options.
- Tax assistance services for foreign colleagues.
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