Executive Director, Asset Development Team Leader

Merck Merck · Pharma · PA

Executive Director leading a cross-functional team to manage the strategy, oversight, and delivery of end-to-end activities for new or marketed oncology drugs, from discovery through reimbursement.

What you'd actually do

  1. Creation, alignment, execution, and adaptation of the asset strategy cross-functionally
  2. Lead the asset development team to maximize the asset’s potential
  3. Identifying registrational opportunities for pre-clinical and early clinical candidates which have potential to become medicines
  4. Evaluating pre-clinical and translational work for the purpose of strategizing early clinical development plan and Investigational New Drug applications in context of potential registration
  5. Working with relevant clinical teams to develop clinical development strategies for investigational or marketed assets that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations

Skills

Required

  • 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
  • Has designed, executed, and reported out phase 3 or registrational studies
  • has supported or led submission activities for labels
  • supported in post approval launch readiness such as publication planning, guideline submission, HTA negotiations
  • Experience 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
  • Experience and understanding of asset and org needs for commercialization and reimbursement of approved medicines
  • 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
  • ability to function in a team environment
  • High level of verbal and written communication
  • presentation skills
  • Strong learning agility
  • growth mindset
  • Experience with multiple modalities of therapies (biologics, small molecules, etc.)

Nice to have

  • Board certified or board eligible in hematology, medical oncology, radiation oncology, surgical oncology or related disciplines

What the JD emphasized

  • oncology indications
  • asset strategy
  • clinical development strategies
  • regulatory requirements
  • commercial considerations
  • phase 3 or registrational studies
  • submission activities for labels
  • post approval launch readiness
  • publication planning
  • guideline submission
  • HTA negotiations
  • regulatory agencies
  • dose justification
  • phase 3 design
  • BLA/sBLA
  • global submissions
  • diagnostic use
  • commercialization and reimbursement
  • drug manufacturing parameters
  • Key Opinion Leaders