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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 processes, regulatory interactions, and cross-functional collaboration within clinical and translational studies. Possesses strong analytical and strategic thinking skills to drive innovation and ensure patient safety in clinical trials.
Highest-signal resume keywords
Medical DegreeClinical Trial ConductGCP and ICH GuidelinesRegulatory InteractionsCross-Functional Matrix Leadership
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 PlansMedical MonitoringClinical Data InterpretationClinical Trial DesignTranslational Studies ExecutionIND/NDA SubmissionsSafety ReviewPharmaceutical DevelopmentBiotechnology Clinical DevelopmentHuman Translational Data Analysis
Soft Skills
Scientific CommunicationInfluencing StakeholdersTeam LeadershipChange ManagementMentorship
Certifications & Qualifications
Postgraduate Clinical TrainingBoard CertificationAdvanced Specialty Training
Industry Keywords
Clinical ResearchRegulatory FrameworksAging ResearchPublic Health NeedsClinical Practice TrendsDrug DevelopmentMatrix EnvironmentKey External Experts EngagementClinical Efficacy EndpointsReal-World Data
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide clinical and scientific leadership to clinical and translational studies or programs for asset-level projects
- Contribute to assessment of potential mechanisms and targets, target validation programs, life-cycle expansion, and innovative clinical development opportunities
- Develop and execute clinical development plans and contribute to foundational and real-world data, translational, and biomarker capabilities
- Align translational and clinical plans and study designs with project strategies
- Develop sections of core regulatory documents
- Generate data and evidence to determine target efficacy, safety profile, differentiation, and route to becoming a medicine
- Define and deliver clinical pillars of the translational table
- Deliver clinical development and study timelines and endpoints, including pharmacology, mechanism, and clinical efficacy endpoints
- Establish and maintain relationships across Biology, Translational Sciences, Commercial, Regulatory, Clinical Operations, Market Access, Medical Affairs, and Statistics
- Provide oversight of R&D evidence generation strategy and study delivery
- Design clinical development plans, study protocols, and associated documents across all development phases
- Support regulatory interactions and prepare briefing documents, presentations, questions, and responses
- Provide medical monitoring and safety oversight of study participants
- Ensure scientific integrity and overall safety through medical governance
- Lead the Clinical Matrix Team for a program and serve as a clinical point of contact
- Lead end-to-end clinical development strategy for early programs
- Engage with regulatory agencies, key opinion leaders, clinical investigators, and internal review boards
- Assist with clinical evaluation of business development opportunities
- Monitor advances in research, trial methodologies, competition, and regulatory developments
- Identify transformational opportunities that may significantly benefit patients
- Integrate cross-disciplinary inputs into Medicine Profile clinical components
- Resolve study and clinical development challenges
- Drive innovation and develop new scientific and technical solutions
- Influence stakeholders, inspire teams, and manage conflicts
- Apply enterprise mindset, strategic thinking, data analysis, and adaptability in ambiguous environments
Requirements
What you’ll need- Medical Degree
- Completion of a formal postgraduate clinical training, clinical residency or specialty training in Internal Medicine, Pathology, etc.
- Demonstrated experience in clinical trial conduct, including medical monitoring, safety review, and clinical data interpretation
- Strong working knowledge of clinical development processes, including GCP, ICH guidelines, and global regulatory frameworks
- Ability to apply clinical judgement to support study design, patient safety, and real-time medical decision-making within a structured clinical development framework
- Experience operating effectively within cross-functional matrix teams in a pharmaceutical, biotechnology, or academic clinical trial environment
- Strong scientific communication skills, with the ability to translate clinical data into clear insights for internal and external audiences
- Experience with research and development across different areas of human disease-relevant biology and clinical specialties beyond a single organ
- Completion of advanced specialty training, fellowship or country-equivalent higher-level qualification leading to recognition as a medical specialist through formal certification, board certification, or country specific professional designation
- Experience in pharmaceutical or biotechnology clinical development across early phase studies
- Clinical experience in relevant specialty and/or relevant therapeutic areas, with direct exposure to clinical research or drug development in industry or postgraduate work
- Robust knowledge of aging research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution
- Knowledge of and experience in the execution of clinical and/or translational studies including generation and analysis of human translational data and conduct of preclinical biological experiments in relevant model systems
- Experience working with global regulatory agencies and managing global clinical trials in relevant disease area
- Prior experience contributing to regulatory interactions, including IND submissions, scientific advice, NDA/MAA filings
- Demonstrated experience engaging with Key External Experts, investigators, and scientific collaborators in aging disease areas
- Demonstrated ability to work collaboratively in cross-functional teams and a matrix environment to design and execute trials to regulatory standards
- Experience in contributing to IND/CTA, NDA, BLA, or MAA submissions
- Strong skills in analytical thinking, business acumen, change management, clinical research, clinical trial designs, decision making, influencing, leadership, matrix leadership, mentorship, people management, risk management, and strategic thinking
Benefits
Comp & perks- Annual bonus
- Eligibility to participate in a share based long term incentive program
- Health care and other insurance benefits for employee and family
- Retirement benefits
- Paid holidays
- Vacation
- Paid caregiver/parental and medical leave