Senior Director,Global Clinical Program Leader Job False Pass Alaska USA,Research/Development

Position: Senior Director, Global Clinical Program Leader,
Location: False Pass

Senior Director, Global Clinical Program Lead, Cardiovascular

Location:

King of Prussia, PA;
Waltham, MA;
Maidenhead, UK;
Zurich, Switzerland. Hybrid position, onsite three days a week.

Responsibilities

Design and execute the clinical strategy to support the development of a medicine aligned with the Project Strategy Document (PSD) and the Target Product Profile (TPP).

Strategic leadership of the Clinical Development Team (CDT) in a matrix environment, accountable for the timely development and execution of the Clinical Development Plan (CDP).

Manage day‑to‑day operations of the CDT, including coordination, documentation, decision‑making, and stakeholder management.

Ensure program alignment with CSL Behring processes, GCP, and ICH regulations.

Provide high‑quality clinical and scientific oversight of assigned program(s).

Serve as medical monitor or supervise medical monitor for assigned clinical trials.

Act as Clinical Development representative on Delivery Teams (DT) such as Safety Management Team, Benefit‑Risk Assessment Team, Biomarker Expert Team, Evidence and Access Strategy Team.

Author key study documents: CDP, PSD, Investigator Brochures, Clinical Study Protocols, Informed Consent Forms, Medical Monitoring Plans, Clinical Study Reports.

Provide clinical sections of regulatory packages (e.g., IND, NDA, annual reports) and support regulatory RFIs.

Develop and execute Medical Monitoring Plan strategy and present results to Safety Monitoring Committee and other meetings.

Review study data, provide insights into safety and efficacy, contribute to development strategy and publication strategy (abstracts, presentations, manuscripts).

Qualifications and Experience

Advanced degree (MD or PhD) in life science/healthcare; MD with board certification preferred.
Clinical development industry experience with knowledge of pharmaceutical and regulatory processes.
Minimum 5 years of relevant clinical development experience, including study data review in a pharmaceutical or clinical environment.

Benefits

Employees working at least 30 hours per week are eligible for benefits effective day one. Benefits cover health care, financial protection, mental health resources, family planning, emergency backup care, summer camp, and charitable matching contributions. See benefits at

EEO Statement

CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status, or any classification protected by applicable law. CSL complies with all applicable employment laws, including TitleVII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act.

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