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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical development, regulatory processes, and stakeholder management, with a strong focus on scientific guidance and cross-functional collaboration. Proficient in clinical data analysis, medical writing, and project management within the pharmaceutical and biotechnology sectors.
Highest-signal resume keywords
MD, PhD Or PharmD In Life Science/HealthcareExtensive Clinical Development ExperienceClinical Data Analysis And InterpretationProgram Leadership In A Matrix EnvironmentEffective Communication And Presentation Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Development PlansClinical Study ReportsRegulatory Interaction PackagesMedical Monitoring Plan StrategiesStudy Data Review/EvaluationAnalytical ThinkingScientific/Medical WritingRisk MitigationProject Management TerminologyProblem-Solving
Soft Skills
Stakeholder ManagementCross-Functional CollaborationCritical ThinkingCommunication SkillsPresentation Skills
Certifications & Qualifications
MD Board Certification Or Non-USA Equivalent
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryGCP/ICH RegulationsDue DiligenceTarget Product ProfilesKOL FeedbackClinical ProgramsSafety Monitoring CommitteesPublication StrategyTherapeutic-Area Leadership
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Serve as clinical representative on due diligence teams evaluating external assets
- Create clinical development plans, slide decks, clinical input, expert KOL feedback, and management presentations
- Develop high-level target product profiles for internal pre-clinical assets with commercial teams
- Lead Clinical Development Teams and provide scientific guidance across functions
- Develop and maintain Clinical Development Plans aligned with program and therapeutic-area leadership
- 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 and GCP/ICH regulations
- Drive and document team decisions, issue resolution, escalation, and contingency planning
- Oversee clinical content and quality of assigned clinical programs
- Represent clinical development on cross-functional teams including SET, SMT, BRAT, BET, and EAST
- Develop and execute Medical Monitoring Plan strategies and serve as or oversee medical monitors
- Present results to Safety Monitoring Committees and other internal and external meetings
- Participate in or lead due diligence projects supporting external innovation
- Review study data to assess safety, efficacy, and implications for R&D strategy
- Author or contribute to clinical development documents, protocols, informed consent forms, monitoring plans, committee charters, and clinical study reports
- Lead clinical sections of regulatory interaction packages, including INDs, NDAs, BLAs, ODDs, RFIs, and routine reporting
- Contribute to publication strategy and author abstracts, presentations, and manuscripts
Requirements
What you’ll need- MD, PhD or PharmD in life science/healthcare required
- MD board certification (or non-USA equivalent) in a relevant field preferred
- Extensive clinical development pharmaceutical/biotechnology industry experience
- Working knowledge of pharmaceutical and regulatory development processes
- 3+ years of relevant clinical development experience, including study data review/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
- Proven analytical thinking and scientific/medical writing skills
- Proficiency in clinical data analysis and interpretation
- Proven problem-solving and critical-thinking skills
- Effective communication and presentation skills
- Ability to build bridges and improve cross-functional collaboration
- Relocation assistance and visa sponsorship are not provided
Benefits
Comp & perks- Relocation assistance and visa sponsorship are not provided
- Incentive compensation may be included
- Equity may be included
- CSL benefits and well-being programs
- Inclusion and belonging programs
- Reasonable accommodation for applicants with disabilities