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Senior Director, Early Clinical Development – Neuroscience
Bristol Myers Squibb. Own the clinical strategy for one or more neuropsychiatry programs .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in clinical development strategies, particularly in neuropsychiatry, with a strong focus on regulatory submissions, clinical trial design, and execution. Proven leadership in managing complex clinical programs and mentoring clinical professionals while ensuring compliance with GCP standards.
Highest-signal resume keywords
Clinical Development ExpertiseClinical Trial DesignRegulatory SubmissionsLeadership in Matrix EnvironmentGCP Compliance
ATS Keywords
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Hard Skills
Clinical Trial DesignClinical Development StrategyData AnalysisRegulatory SubmissionsClinical Study ReportsRisk Management PlansPatient SelectionSafety Data ReviewMentorshipExecutional Priorities
Soft Skills
Leadership AbilitiesCollaborationRelationship BuildingCommunication
Certifications & Qualifications
MDMD/PhD
Industry Keywords
NeuropsychiatryTranslational ResearchPharmaceutical DevelopmentBiotechClinical ResearchGCPClinical ConductTherapeutic Area ExpertiseKOL EngagementMatrix Leadership
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Own the clinical strategy for one or more neuropsychiatry programs
- Serve as the clinical point of accountability for the Clinical Development Team
- Develop and implement clinical development strategies
- Analyze, interpret, and leverage clinical trial data
- Author regulatory submissions, Clinical Study Reports, and scientific publications
- Develop trial designs, development strategies, and regulatory strategies based on emerging data
- Design and develop clinical studies and research plans
- Manage multiple complex programs across clinical lifecycles
- Lead indication strategy and contribute to integrated disease area strategies
- Review and interpret safety data with Worldwide Patient Safety physicians
- Partner with KOLs and establish relationships with key investigators
- Develop asset-level risk management plans and resolve quality and clinical issues
- Set executional priorities and support study delivery
- Oversee top-line data with Clinical Scientists and Statisticians
- Define dose and schedule, indications, and patient selection with scientific and development teams
- Present clinical strategy to senior leadership
- Represent the department in regulatory interactions, business development due diligence, and partner alliance management
- Potentially manage, mentor, and develop Clinical Trial Physicians and Clinical Scientists
- Ensure adherence to GCP and compliance obligations
Requirements
What you’ll need- MD or MD/PhD
- Deep clinical development expertise in psychiatry
- Fellowship/specialty training in relevant therapeutic area preferred
- 7+ years of relevant experience in translational and/or clinical research in an industry or biotech setting
- Extensive experience in clinical trial design and execution, and development strategy in pharmaceutical industry or biotech
- Deep understanding of pharmaceutical discovery, development and commercialization
- Track record of mentorship and/or management and/or matrix leadership
- Demonstrated leadership abilities in a matrix environment
- Extensive experience in clinical development in neuropsychiatric indications
- Ability to travel domestically and internationally as required
- Commitment to GCP and compliance obligations for clinical conduct
Benefits
Comp & perks- Opportunities for growth
- Supportive environment
- Inclusion-focused culture
- Wellbeing support
- Flexibility
- Comprehensive benefits
- Reasonable workplace accommodations/adjustments
- Ongoing support for people with disabilities