Medical Director, Global Clinical Program Leader - Immunology

CSL • Waltham, MA

1d • $300,000 - $376,000 • Hybrid

About The Position

CSL Behring is seeking a Medical Director, Global Clinical Program Leader in Immunology to provide clinical and scientific leadership for clinical programs and support internal pre-clinical assets and external innovation. The role is hybrid, based onsite at one of the posted locations at least three days per week. Relocation assistance and visa sponsorship are not provided.

The role leads cross-functional Clinical Development Teams (CDTs), serving as the lead scientific expert and coordinating program strategy, clinical development plans, stakeholder alignment, decision-making, issue resolution, escalation, and contingency planning. It ensures programs follow CSL Behring processes and applicable GCP and ICH regulations.

The position oversees clinical and scientific quality across program deliverables, contributes to cross-functional study and safety teams, and develops and executes medical monitoring strategy. It reviews study data and contributes to clinical development strategy, regulatory interaction materials, study documents, and scientific publications. The role may also support due diligence for external assets and CSL’s external innovation efforts.

The expected base salary range for the Waltham, Massachusetts work location is $300,000–$376,000 per year. Individual salary depends on qualifications, skills, experience, competencies, and other relevant factors. Total compensation may also include incentive compensation and equity. CSL describes itself as a global biotherapeutics leader focused on developing therapies across several therapeutic areas, including immunology. Its parent company employs 32,000 people and delivers therapies in more than 100 countries.

Requirements

• MD, PhD, or PharmD in life science or healthcare required.
• Extensive clinical development experience in the pharmaceutical or biotechnology industry, with working knowledge of pharmaceutical and regulatory development processes.
• At least 3 years of relevant clinical development experience, including study data review or evaluation in a pharmaceutical or clinical study environment.
• Demonstrated program leadership capabilities in a matrix environment.
• Demonstrated stakeholder management skills, including risk mitigation.
• Proficiency in project management terminology and processes to drive clinical development program risk mitigation strategies.
• Proven analytical thinking and scientific or medical writing skills.
• Proficiency in clinical data analysis and interpretation.
• Proven problem-solving skills and ability to think critically and make informed decisions.
• Effective communication and presentation skills.
• Ability to build bridges and proactively improve cross-functional collaboration.

Nice To Haves

• MD board certification, or non-U.S. equivalent, in a relevant field.

Responsibilities

• Serve as clinical representative on due diligence teams evaluating external assets, preparing clinical development plans, slide decks, clinical input, expert KOL feedback, and management presentations.
• Work with Commercial to develop high-level target product profiles for internal pre-clinical assets, develop clinical development plans, and present at developmental Stage Gate meetings.
• Lead and guide cross-functional Clinical Development Team members as the lead scientific expert, ensuring appropriate functional representation.
• Develop and maintain the Clinical Development Plan in alignment with the Program Strategy Team and Therapeutic Area Leadership Team.
• Integrate internal and external expert contributions into the strategy and design of assigned clinical programs.
• Maintain stakeholder alignment before key decision-making forums, including the Strategic Development Committee and Scientific and Technical Review Committee.
• Ensure programs are conducted in alignment with CSL Behring processes and GCP and ICH regulations.
• Drive and document CDT decision-making; facilitate issue resolution and escalation, and develop contingency plans.
• Oversee clinical content for CDT deliverables and ensure safe, efficient, timely, high-quality program execution and scientific standards.
• Represent clinical development on cross-functional teams, including the Study Execution Team, Safety Management Team, Benefit-Risk Assessment Team, Biomarker Expert Team, and Evidence and Access Strategy Team.
• Develop and execute Medical Monitoring Plan strategy; typically serve as medical monitor during trials or oversee assigned medical monitors.
• Present results to Safety Monitoring Committee and other internal and external meetings.
• Review study data to understand safety and efficacy results and their implications for ongoing R&D strategies and development strategy.
• Lead or contribute to key study documents, including target product profiles, product strategy documents, clinical development plans, study concept scenarios, study outlines, investigator brochures, clinical study protocols, master informed consent forms, medical monitoring plans, safety review committee and independent data monitoring committee charters, and clinical study reports.
• Lead preparation of clinical sections of regulatory interaction packages, including briefing books, INDs, NDAs, BLAs, ODDs, requests for information, and routine reporting.
• Contribute to publication strategy and author or contribute to abstracts, presentations, and manuscripts as appropriate.
• May participate in or lead due diligence projects supporting CSL’s external innovation efforts.

Benefits

• The role may include incentive compensation and equity in addition to base salary.
• CSL provides employee benefits; details are available on the company’s benefits website.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree