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Senior Director, Clinical Development – MD
Gilead Sciences. Provide clinical oversight and medical monitoring to one or more clinical trials .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive clinical research and drug development expertise, particularly in neurology and neuro autoimmune diseases, with a strong focus on leading clinical trials and regulatory compliance. Proven ability to collaborate cross-functionally and provide strategic leadership while maintaining excellent relationships with stakeholders.
Highest-signal resume keywords
MD/DOClinical Research ExperienceDrug Development ExperiencePhase 1-3 Trials ManagementNeurology Specialization
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 WritingRegulatory ComplianceClinical Study Report WritingInvestigator Meeting ConductingBLA and MAA Regulatory FilingsProof-of-Concept StudiesFirst-in-Human StudiesContingency PlanningTechnical and Strategic Advice
Soft Skills
Strategic LeadershipExcellent InitiativeJudgmentCross-Functional CollaborationCritical Thinking
Certifications & Qualifications
Board Certification in Neurology
Industry Keywords
Clinical TrialsDrug DevelopmentNeuro Autoimmune DiseasesClinical OversightInvestigator BrochuresScientific PublicationBusiness Development OpportunitiesPatient Advocacy GroupsClinical OperationsBiomarker Specialists
About the role
Key responsibilities & impact- Provide clinical oversight and medical monitoring to one or more clinical trials
- Lead project teams to design and implement clinical studies
- Write protocols, investigator brochures, clinical study reports and review clinical trial documents
- Conduct investigator meetings and lead site initiation visits
- Implement drug development strategic plans and 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
- Work with regulatory affairs and ensure compliance with external ethical guidelines
- Collaborate cross-functionally with pre-clinical scientists, translational scientists, business and commercial organizations
- Work with clinical operations, biomarker specialists, CROs and regulatory affairs
- Provide clinical expertise for BLA and MAA regulatory filings and responses to regulatory authorities
- 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 evaluating business development opportunities
- Create inclusion, develop talent and empower teams as a people leader
Requirements
What you’ll need- MD/DO and 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, either 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, with emphasis on proof-of-concept and first-in-human studies
- Strategic leadership and tactical skills, excellent initiative and judgment
- Ability to develop and maintain excellent working relationships with internal colleagues and external contacts
- Ability to work well in cross-functional teams
- Ability to communicate and work in a self-guided manner with scientific/technical personnel
- Critical thinking, troubleshooting and problem-solving skills
- Self-motivated and willing to accept responsibilities outside of the initial job description
- Comfortable in a dynamic small company environment with minimal direction
- Ability to adjust workload based upon changing priorities
- May travel up to 25%
Benefits
Comp & perks- Discretionary annual bonus eligibility
- Discretionary stock-based long-term incentives eligibility may vary based on role
- Paid time off
- Company-sponsored medical insurance
- Company-sponsored dental insurance
- Company-sponsored vision insurance
- Company-sponsored life insurance