Senior Director, Global Program Team Lead Cell Therapy

AstraZeneca • Boston, MA

18h

About The Position

As the Senior Director, Global Program Team Lead Cell Therapy, you will be at the forefront of providing strategic direction and leading one or more programs. You will drive the creation of an integrated development plan while maintaining strategic focus and ensuring commitments are met. Partnering with team members and collaborators, both within and outside R&D, you will stimulate creative discussion, motivate ownership, encourage urgency, and facilitate robust risk identification and mitigation. Representing the program to leadership and review committees, you will act as the liaison to other groups, ensuring clarity of purpose and responsibilities within the team.

Requirements

• Graduate degree in a life science field (nice to have MSc, PhD, MD/PhD, or PharmD).
• Experience in preclinical drug discovery and development in the pharmaceutical or biotechnology industries
• Experience leading clinical drug development programs in a matrixed, global organization.
• Excellent critical thinking, problem-solving, and decision-making skills.
• Excellent communication and interpersonal skills, with the ability to influence others without direct authority, including team members, senior leaders, collaborators, and external decision-makers.
• Regulatory experience that includes a Pre-IND meeting, Scientific Advice meeting, or IND/CTA filing.
• A thorough understanding of the global scientific, regulatory, and commercial environments relevant to drug development.
• Minimum of ten (8) years of experience in drug development in pharmaceuticals, biopharmaceuticals, biotechnology or equivalent cross-functional leadership experience.
• Total leadership experience including line/project management, multidisciplinary program management experience, which includes leadership in more than one IND/IMPS, BLA/NDA/MAA, Advisory Committee or other PMDA/EMA/FDA meetings is desirable
• 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
• Has experience leading preparation of PMDA/EMA/FDA milestone meetings, such as Pre-IND, EoP-1, EoP-2, Pre-BLA/NDA, Advisory Committees, focusing on the key strategic issues
• 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 behaviours.

Nice To Haves

• MSc, PhD, MD/PhD, or PharmD

Responsibilities

• Strategic direction and leadership of cross-functional early global program team(s) from candidate selection (CSID) through development investment decision (CDID) to IND acceptance in accordance with organizational goals.
• Program ownership with final accountability for strategy, goals, and deliverables.
• In partnership with the program manager and core team, develop and implement an efficient integrated plan and timeline for achieving program goals and achievements.
• Lead the program team in developing preclinical, clinical, regulatory, translational, biomarker, diagnostics, CMC, and clinical development plans through to approval to meet the target product profile.
• Identify potential risks to program objectives and timelines. Develop and implement mitigation strategies and ensure contingencies are in place.
• Build competitive intelligence to develop preclinical and clinical differentiation strategies supporting the reason for investment.
• Act as point of contact and project representative to governance, decision-making bodies, and senior leadership including information dissemination and the resolution of critical project issues.
• Ensure efficient writing and timely submission of the IND/CTA (and IDE if needed); coordinate and author sections of key regulatory documents as needed.
• Responsible for overall excellence, quality, and rigor, holding team members accountable for meeting high standards.
• Negotiate with and influence key internal and external collaborators to achieve program goals.
• In partnership with the program manager, develop the budget and maintain adherence to forecasts.
• Resolve resourcing issues, applying expertise to stay on schedule and on budget.
• Contribute to objective setting and appraisal of core team members for program-related activities.
• Create a motivated, committed, and engaged project team; ensure effective team behavior with clear roles and responsibilities.

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees