Sr. Director - Clinical Development Program Lead; CDPL - Early Oncology

Purpose

The Clinical Development Program Lead (CDPL) is the single point of accountability for the cross-functional global clinical development of a given asset or portfolio of assets. As such, the CDPL ensures asset profiles and strategies are developed and clearly defined and leads effective and efficient development and delivery of asset clinical plans. The CDPL achieves this through strong partnerships and influence with asset team leadership (e.g. team leader, COO, medical director, lead CRP) and cross-functional team members from across the CDDA.

The CDPL is accountable for developing and maintaining expertise in their therapeutic area including current and evolving clinical paradigms and knowledge of the competitive landscape. The CDPL is also accountable for high quality, efficient execution of the clinical plan, including proactive operational risk management, tracking progress-to-plan, and identifying acceleration opportunities. Finally, the CDPL is accountable for managing cross-functional support of key clinical deliverables in support of submissions, inspections, and publications.

The Clinical Development Program Lead reports to the Associate Vice President within their assigned therapeutic area.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

• Single clinical development point of accountability for assigned asset(s) from strategy and profile development through to submission, approval and post‑launch support.
• Collaborates with and influences asset teams to create competitive profiles and partners across the CDDA to ensure the creation of viable clinical scenarios. Drives communication of options with the asset team and clinical plan decision making.
• Identifies and supports novel development approaches that have the potential to accelerate the development of assets.
• Champions the asset strategy and drives translation of the strategy to the Clinical Development Trial Lead staff. Ensures that all clinical functions understand the strategy, timelines and risks.
• Demonstrates strong business acumen, problem‑solving skills, and agility to help team plan for contingencies, and adjust to changes.
• Demonstrates a strong understanding of clinical paradigms and the external competitive landscape and how competitor trials are designed, etc.

• Partners across the CDDA to ensure delivery of the complete trial package (scope, timeline, budget and risk management) that enables the rapid transition into trial execution.
• Ensures the risk plans are developed and maintained during clinical plan implementation in response to new data and changes in the environment.
• Promotes cross‑functional and cross‑phase collaboration to drive efficient implementation.
• Represents clinical functions at asset team core meetings. Ensures streamlined and efficient project and meeting management.
• Accountable for budget planning, monitoring and control of the overall clinical plan and budget.
• Documents and communicates key decisions, actions, and modifications in clinical scope, resources, timeline and risks.

• Communicates and aligns cross‑functional resources based on portfolio prioritization inclusive of being flexible across therapeutic areas.
• Maintains compliance culture and a state of inspection readiness for clinical research activities.
• Models judgement‑based decision making to navigate compliance and quality requirements.
• Responsible for identification of continuous improvement opportunities in the spirit of streamlining the efficiency and effectiveness of conducting clinical trials and non‑trial work.
• Supports and encourages a culture of innovation and the learning that comes from new/novel approaches to clinical development.
• Creates and models an inclusive culture to…