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Senior Medical Director, Global Clinical Program Lead – Immunoglobulins
CSL. Design and execute clinical strategy supporting medicine development in alignment with the Project Strategy Document and Target Product Profile .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical strategy design and execution, ensuring alignment with regulatory standards and stakeholder expectations. Proven ability to lead cross-functional teams and manage clinical development processes effectively.
Highest-signal resume keywords
Clinical Development LeadershipStakeholder ManagementClinical Data AnalysisRegulatory Compliance (GCP, ICH)Medical Monitoring
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Development StrategyClinical Development PlanStudy Data ReviewAnalytical ThinkingScientific WritingProject ManagementProblem-SolvingCross-Functional CollaborationRisk MitigationDecision-Making
Soft Skills
Effective CommunicationPresentation Skills
Certifications & Qualifications
MDPhDPharmDMD Board Certified
Industry Keywords
Pharmaceutical IndustryClinical TrialsRegulatory Development ProcessesTherapeutic Area LeadershipMedical Monitoring Plan
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Design and execute clinical strategy supporting medicine development in alignment with the Project Strategy Document and Target Product Profile
- Provide strategic leadership of the Clinical Development Team in a matrixed environment
- Lead and guide cross-functional Clinical Development Team members as the lead scientific expert
- Develop and maintain the Clinical Development Plan aligned with the Program Strategy Team and Therapeutic Area Leadership Team
- Integrate internal and external expert contributions into clinical program strategy and design
- Maintain stakeholder alignment before key decision-making forums
- Ensure programs follow CSL Behring processes, GCP, and ICH regulations
- Drive and document Clinical Development Team decision-making, issue resolution, escalation, and contingency planning
- Oversee clinical content and ensure safe, efficient, timely, and high-quality execution of clinical programs
- Serve on cross-functional teams including SET, SMT, BRAT, BET, and EAST
- Develop and execute Medical Monitoring Plan strategy
- Serve as medical monitor or oversee assigned medical monitors
- Present results to Safety Monitoring Committee and other internal and external meetings
- Participate in or lead due diligence projects supporting external innovation
- Review study data to assess safety, efficacy, and impact on R&D strategies
- Author or contribute to key study documents, regulatory interaction packages, publications, abstracts, presentations, and manuscripts
Requirements
What you’ll need- MD, PhD or PharmD in life science/healthcare discipline expected
- MD Board Certified (or non-USA equivalent) in relevant field preferred
- 5+ years of relevant clinical development experience in the pharmaceutical industry expected
- Experience with study data review/evaluation
- Clinical development industry experience with working knowledge of pharmaceutical and regulatory development processes
- Demonstrated program leadership capabilities in a matrixed environment
- Demonstrated stakeholder management skills including risk mitigation
- Proficient in project management terminology and processes
- Excellent analytical thinking and scientific/medical writing skills
- Proficient in clinical data analysis and interpretation
- Proven effective problem-solving skills and ability to think critically and make informed decisions
- Demonstrated effective communication and presentation skills
- Ability to build bridges and proactively improve cross-functional collaboration
- Must work onsite at a posted location at least 3 days weekly
- Relocation assistance and visa sponsorship are not provided
Benefits
Comp & perks- Incentive compensation may be included in total compensation
- Equity may be included in total compensation
- Relocation assistance and visa sponsorship are not provided