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Senior Director, Clinical Development – MD
Gilead Sciences. Provide clinical oversight and medical monitoring for one or more clinical trials .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial oversight and drug development, with a strong focus on neurological diseases and regulatory compliance. Proven ability to lead cross-functional teams, develop strategic plans, and communicate effectively with stakeholders.
Highest-signal resume keywords
MD/DO6+ Years Clinical Research ExperienceDrug Development in Neurological DiseasesPhase 1–3 Trial ManagementRegulatory Compliance Expertise
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 Trial DesignProtocol WritingClinical Study Report WritingInvestigator Meeting ConductingRegulatory Filing ExpertiseStrategic PlanningContingency PlanningClinical EvaluationProof-of-Concept StudiesFirst-in-Human Studies
Soft Skills
Strategic LeadershipExcellent InitiativeJudgmentCritical ThinkingProblem-Solving
Certifications & Qualifications
Board Certification in Neurology
Industry Keywords
Clinical OversightMedical MonitoringPharmaceutical IndustryCross-Functional CollaborationThought Leader InteractionPatient Advocacy GroupsScientific PublicationDynamic Environment Adaptability
About the role
Key responsibilities & impact- Provide clinical oversight and medical monitoring for one or more clinical trials
- Lead project teams in designing and implementing clinical studies
- Write protocols, investigator brochures, and clinical study reports; review clinical trial documents
- Conduct investigator meetings and lead site initiation visits
- Implement drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
- Translate research and nonclinical findings into clinical development opportunities
- Interact with clinical investigators and thought leaders
- Ensure compliance with regulatory and ethical guidelines relevant to the pharmaceutical industry
- Collaborate cross-functionally with pre-clinical scientists, translational scientists, business, commercial, clinical operations, biomarker, CRO, and regulatory affairs teams
- Provide clinical expertise for regulatory filings, including BLA and MAA, and respond to regulatory authority questions related to IND submissions, clinical trial applications, and filing procedures
- Guide interactions with medical experts, advisory boards, patient advocacy groups, and internal stakeholders
- Present scientific information at conferences and investigator meetings; lead scientific publication authorship where applicable
- Assist in clinical evaluation of business development opportunities
- Create inclusion, develop talent, and empower teams as a people leader
Requirements
What you’ll need- MD/DO
- 6+ years of clinical research or drug development experience
- Board certification/specialization in neurology preferred
- Experience managing Phase 1–3 trials preferred
- 4+ years of relevant drug development experience, within industry or as a clinical investigator/physician scientist in academia, or equivalent experience
- Drug development experience in neurological diseases, including neuro autoimmune diseases, highly desired
- Experience designing, implementing, and conducting clinical trials, emphasizing proof-of-concept and first-in-human studies
- Strategic leadership and tactical skills, excellent initiative and judgment
- Ability to develop and maintain working relationships with internal colleagues, external contacts, thought leaders, and investigators
- Ability to work cross-functionally in teams
- Ability to communicate and work independently with scientific/technical personnel
- Critical thinking, troubleshooting, and problem-solving skills
- Willingness to accept responsibilities outside the initial job description
- Comfort working in a dynamic small-company environment with minimal direction
- Ability to adjust workload based on changing priorities
- May travel up to 25%
Benefits
Comp & perks- Discretionary annual bonus
- Discretionary stock-based long-term incentives
- Paid time off
- Company-sponsored medical insurance
- Company-sponsored dental insurance
- Company-sponsored vision insurance
- Company-sponsored life insurance