Executive Director, Asset Development Team Leader

Merck • North Wales, PA

2d • 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.

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.)
• Asset Development
• Business Mindset
• Clinical Development
• Clinical Research
• Clinical Trials
• Consultative Approach
• Drug Development
• Hematology
• Innovation
• Leadership
• Medical Research
• Oncology
• Results-Oriented
• Safety Management
• Scientific Consulting
• Strategic Leadership

Nice To Haves

• Current Employees apply HERE
• Current Contingent Workers apply HERE
• US and Puerto Rico Residents Only:
• San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
• Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
• Search Firm Representatives Please Read Carefully
• Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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 a complex matrix of internal stakeholders within clinical development (i.e. across existing PDTs and TAs) and across functions
• Mentoring and career development for direct reports (when applicable) will be a key function of the role.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays, vacation, and compassionate and sick days.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree