Executive Director, Global Program Team Leader Cell Therapy
Alexion

Job Info

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This is what you will do:

Reporting to the TA Head, the ED, GPTL is responsible for providing strategic direction and leading the global drug development with one or more assets that have multiple indications in development.

As the accountable program(s) owner, the GPTL, leads and chairs the Global Project Team (GPT), which determines the overall strategy for the asset across indications.

The GPT is responsible for creating an integrated development plan for each indication and overseeing the program. The GPTL is the "one voice" for the GPT up the line (R&D Leadership, Development Steering Committee and Executive Steering Committee). The GPT role is one of leadership, being proactive and interactive, and emphasising partnership with all GPT members and Project Subteams, functional heads and consultants both within and outside R&D. The GPTL should stimulate creative and productive discussion, motivate, ownership and urgency (when necessary) as well as robust discussions of risk identification and mitigation opportunities, and ensure clarity of purpose and responsibilities with the GPT. The GPTL has the negotiation and persuasion skills necessary to ensure the program's success and sets goals for the GDT and specific program-related goals for the Core Team members.

You will be responsible for:

The GPTL is accountable for:

• 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 the 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

You will need to have

• 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.
• Minimum of ten (10) 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 alliance 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 understand of CMC, pharmacology, toxicology, PK, clinical requirements to support major regulatory filings - IND/IMPD, BLA/NDA/MAA
• 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 behaviors.

We would prefer for you to have:

• Advanced life-science degree (MD, PhD or PharmD) is preferable, with a speciality in Advanced Therapies or equivalent experience with global development required.
• Hands-on experience in developing Gene or cell therapy assets in clinical stage.

Date Posted
07-May-2024

Closing Date
23-Jun-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

This job has expired.