Senior Director, Global Program Team Leader

Alexion • Boston, MA

5d • Onsite

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 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 R&D Leadership, the Development Steering Committee, and the Executive Steering Committee. This role requires leadership, proactivity, and partnership with all GPT members, 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, and ensure robust identification and mitigation of risks. Clarity of purpose and responsibilities within the GPT is essential. The GPTL must possess the negotiation and persuasion skills necessary for program success and sets goals for the Global Development Team (GDT) and specific program-related goals for Core Team members.

Requirements

• Total leadership experience including line/project management.
• Multidisciplinary program management experience, including leadership in more than one IND/IMPS, BLA/NDA/MAA, Advisory Committee, or other PMDA/EMA/FDA meetings.
• Minimum of eight (8) 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.
• 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.

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.
• Hands-on experience in developing biological assets in clinical stage.
• Regulatory exposure to major agencies.

Responsibilities

• Program ownership with final accountability for precise definitions of program goals, plans, decisions, and deliverables to meet those goals.
• Developing the overall asset strategy, including indication sequencing and the overall regulatory and CMC strategy to support all indications under development.
• Providing 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.
• Ensuring that the GPT, functional subteams, and GPT members implement plans and adhere to key development milestones for assigned projects.
• Contributing to objective setting and appraisal of core team members for program-related activities.
• Keeping senior management informed.
• Ensuring high-performance team effectiveness.

Benefits

• Eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
• Qualified retirement programs.
• Paid time off (i.e., vacation, holiday, and leaves).
• Health, dental, and vision coverage in accordance with the terms of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Director