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Executive Director, Asset Development
MSDExecutive Director responsible for strategic oversight and delivery in oncology drug development at Merck. Leading cross-functional teams to maximize asset potential in drug lifecycle management.
About the role
Key responsibilities & impact- Primary responsibility for strategy, oversight, and delivery of end-to-end activities involving new or marketed drug(s) for oncology indications
- Leads the team responsible for cross-functional delivery of critical milestones in an oncology asset’s lifecycle
- Creation, alignment, execution, and adaptation of the asset strategy cross-functionally
- Lead the asset development team to maximize the asset’s potential
- Identifying registrational opportunities for pre-clinical and early clinical candidates
- Evaluating pre-clinical and translational work for purpose of strategizing early clinical development plan
- Developing clinical development strategies for investigational or marketed assets
- Prioritizing clinical trials based on these clinical development strategies
- Support asset specific biomarker strategy and diagnostic readiness
- Support asset specific safety management
- Leading development and communication of the messaging around the asset and asset strategy
- Participation in internal and joint internal/external research project teams relevant to new compounds or marketed compounds
- Manage other Directors and/or Senior Directors on the asset development team
- Mentoring and career development for direct reports
- Work across teams and functions internally and/or externally
- Manage a complex matrix of internal stakeholders
- Travel on company business about twenty (20) percent of the time
Requirements
What you’ll need- M.D., or MD/PhD with experience in oncology
- Minimum of 5 years of industry experience in drug development in a relevant therapeutic area
- Minimum of 5 years of clinical experience
- Designed, executed, and reported out phase 3 or registrational studies
- Supported or led submission activities for labels
- Supported in post approval launch readiness such as publication planning, guideline submission, HTA negotiations
- Navigating a matrixed structure including shepherding studies/concepts through internal governance boards
- Expertise as clinical lead for interactions with regulatory agencies
- Experience preferred for the following: dose justification; phase 3 design; BLA/sBLA, global submissions and diagnostic use
- Understanding the impact of drug manufacturing parameters on drug development execution
- Management of external Key Opinion Leaders in Clinical Development and Medical Affairs activities
- Strong interpersonal skills and ability to function in a team environment
- High level of verbal and written communication, including presentation skills
- Strong learning agility and growth mindset
- Experience with multiple modalities of therapies (biologics, small molecules, etc.)
Benefits
Comp & perks- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
drug developmentclinical experiencephase 3 studiesregistrational studiessubmission activitiespublication planningHTA negotiationsdose justificationBLA/sBLAdiagnostic use
Soft Skills
interpersonal skillsteam collaborationverbal communicationwritten communicationpresentation skillslearning agilitygrowth mindsetmentoringleadershipstakeholder management
Certifications
M.D.MD/PhD