Executive Director, Asset Development Team Leader

Merck•North Wales, PA

20h•Hybrid

About The Position

The Executive Director has the primary responsibility for strategy, oversight, and delivery of end-to-end activities involving new or marketed drug(s) for oncology indications. The Executive Director leads the team responsible for the cross-functional delivery of critical milestones in an oncology asset’s lifecycle, spanning discovery through reimbursement, integrating the scientific, commercial, and manufacturing aspects critical to delivering clinically beneficial medicines to the right patients. The key to success is bearing the primary responsibility for developing, aligning, executing, and communicating the overall asset strategy. Specifically, the Executive Director may be responsible for: 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 which have potential to become medicines 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 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 Prioritizing clinical trials (design, operational plans, settings) based on these clinical development strategies for what is optimal for the asset in the context of internal and external factors Support asset specific biomarker strategy and diagnostic readiness Support asset specific safety management such as safety governance meetings, dose adjustments, supportive care optimization Leading development and communication of the messaging around the asset and the asset strategy Lead interactions with governance to secure alignment and support for asset development Participation in internal and joint internal/ external research project teams relevant to the development of new compounds, and the further study of marketed compounds and support of business development assessments of external opportunities. The Executive Director may manage other Directors and/or Senior Directors on the asset development team Mentoring and career development for direct reports (when applicable) will be a key function of the role. To accomplish these goals, the Executive Director may: Work across teams and functions internally and/or externally (i.e. via collaborations) Manage a complex matrix of internal stakeholders within clinical development (i.e. across existing PDTs and TAs) and across functions Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.

Requirements

M.D., or MD/PhD with experience in oncology
Board certified or board eligible in hematology, medical oncology, radiation oncology, surgical oncology or related disciplines preferred; candidates with an equivalent combination of medical training and experience will be considered.
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, as well as the ability to function in a team environment are essential
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.)
Clinical Development
Clinical Investigations
Clinical Judgment
Clinical Research
Clinical Trial Planning
Cross-Cultural Awareness
Drug Development
Leadership
Professional Networking
Regulatory Requirements
Results-Oriented
Strategic Leadership

Responsibilities

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 which have potential to become medicines
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
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
Prioritizing clinical trials (design, operational plans, settings) based on these clinical development strategies for what is optimal for the asset in the context of internal and external factors
Support asset specific biomarker strategy and diagnostic readiness
Support asset specific safety management such as safety governance meetings, dose adjustments, supportive care optimization
Leading development and communication of the messaging around the asset and the asset strategy
Lead interactions with governance to secure alignment and support for asset development
Participation in internal and joint internal/ external research project teams relevant to the development of new compounds, and the further study of marketed compounds and support of business development assessments of external opportunities.
Manage other Directors and/or Senior Directors on the asset development team
Mentoring and career development for direct reports (when applicable)