Senior Director, Global Program Team Leader
About The Position
The Senior Director, Global Program Team Leader (SD, GPTL) is responsible for providing strategic direction and leading the global drug development for one late-stage asset with potential for multiple indications or two early-stage assets in different indications. As the accountable program owner, the GPTL leads and chairs the Global Project Team (GPT), which determines the overall strategy for the asset(s) across indications. The GPT is responsible for creating an integrated development plan for each indication and overseeing the program. The GPTL serves as the single point of communication for the GPT to senior leadership, including the R&D Leadership, Development Steering Committee, and Executive Steering Committee. This role requires leadership, proactivity, and a collaborative approach with all GPT members, project sub-teams, functional heads, and consultants within and outside of R&D. The GPTL should foster creative and productive discussions, motivate team members, instill a sense of ownership and urgency when needed, facilitate robust risk identification and mitigation discussions, and ensure clarity of purpose and responsibilities within the GPT. The GPTL must possess the negotiation and persuasion skills necessary for program success and will set goals for the Global Development Team (GDT) and program-specific goals for Core Team members.
Requirements
- Total leadership experience including line/project management and multidisciplinary program management experience, with leadership in more than one IND/IMPD, BLA/NDA/MAA, Advisory Committee, or other PMDA/EMA/FDA meetings.
- Minimum of five years of experience in drug development in pharmaceuticals, biopharmaceuticals, or biotechnology.
- Demonstrated experience leading the development of at least one development candidate with adherence to quality, excellence, and efficiency.
- Demonstrated experience leading drug development projects and activities in a matrixed, global organization.
- A broad understanding of how to communicate and work well with team members and relevant people, as well as scientists and external decision-makers worldwide.
- A thorough understanding of how to influence local and global regulatory, scientific, and commercial environments.
- Ability to assimilate data, recognize key variables, and analyze complex situations to substantiate strategic recommendations.
- Has a realistic expectation of the business, oneself, and others.
- A style which builds alliances within the organization, locally/globally, and/or corporate collaborators.
- Does not confuse effort for results.
- Tenacity to weather short-term setbacks for long-term advantages.
- Broad understanding of the multidisciplinary functions contributing to effective and efficient drug development.
- Solid understanding of CMC, pharmacology, toxicology, PK, and clinical requirements to support major regulatory filings – IND/IMPD, BLA/NDA/MAA.
- Excellent understanding of the interdependencies of the various disciplines (e.g., CMC, Pharm/Tox, PK, Clinical, Regulatory, Marketing, Finance) – what needs to be evaluated simultaneously vs. sequentially etc. from a strategic planning/risk management time/event/cost point locally and globally.
- Has a firm understanding of how to educate/advise/operate with respect to Regulatory Guidances/Internal SOPs/Project best-practice behaviors.
Nice To Haves
- An advanced life-science degree (MD, PhD or PharmD) is preferable, with a specialty in Endocrinology, Metabolism, Rheumatology, Internal Medicine or Clinical Pharmacology or equivalent experience with global development required.
- Hands-on experience in developing biological assets in clinical stage.
- Regulatory exposure to major agencies.
- Excellent written/oral communication skills in English.
- Attention to detail and ability to think strategically.
- Willingness to take on new responsibilities.
- Interest and ability to learn about new therapeutic areas.
- Interest in career progression and ability to take on more senior roles in 1-3 years.
Responsibilities
- Program ownership with final accountability for precise definitions of program goals, plans, decisions, and deliverables to meet those goals.
- Responsible for developing the overall asset strategy, including indication sequencing and the overall regulatory and CMC strategy to support all indications under development.
- Provide strategic direction and leadership to the GPTs to ensure precise goal setting and robust development plans for effective and efficient development of the asset overall.
- Ensures that the GPT, functional subteams, and GPT members implement plans and adhere to key development milestones for assigned projects.
- Contributes to objective setting and appraisal of core team members for program-related activities.
- Keeps senior management informed.
- Ensures high-performance team effectiveness.
Benefits
- Eligibility for various incentives
- Opportunity to receive short-term incentive bonuses
- Equity-based awards for salaried roles
- Commissions for sales roles
- Qualified retirement programs
- Paid time off (i.e., vacation, holiday, and leaves)
- Health coverage
- Dental coverage
- Vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Senior
