Senior Director, Global Program Team Leader

Talantir; Barcelona; On-site; EUR 205,000 - 240,000; Full time

Job summary

Alexion seeks a Global Therapeutic Leadership role to drive strategic direction for late-stage assets, chair the Global Project Team, and own integrated development plans across indications. This role requires leading cross-functional teams, shaping regulatory/CMC strategies, and delivering robust development plans in a global, matrixed environment.

The ideal candidate has extensive leadership experience, a deep drug development background, and the ability to influence regulatory and commercial

Qualifications

• Total leadership experience including line/project management across IND/IMPS, BLA/NDA/MAA meetings.
• Minimum of five (8) years in drug development in pharmaceuticals, biopharmaceuticals, or biotechnology.
• Demonstrated experience leading 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.
• Broad understanding of how to communicate and work with team members and external decision-makers worldwide.

Responsibilities

• Own program ownership with final accountability for goals, plans, decisions and deliverables to meet those goals.
• Develop the asset strategy including indication sequencing and overall regulatory and CMC strategy.
• Provide strategic direction and leadership to GPTs to ensure goal setting and robust development plans.
• Ensure GPT and subteams implement plans and adhere to milestones for assigned projects.
• Keep senior management informed and ensure high-performance team effectiveness.

Skills

Leadership experience

Drug development

Regulatory strategy

Cross-functional collaboration

Strategic planning

Education

Advanced life-science degree

MD/PhD/PharmD preferred

Job description

Reporting to the TA Head, the SD, GPTL is responsible for providing strategic direction and leading the global drug development with one late stage asset that can have multiple indications in development, (or two early assets in different indications).

As the accountable program(s) 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 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 emphasizing partnership with all GPT members and Project Sub teams, 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 oneIND/IMPS, BLA/NDA/MAA, Advisory Committee or other PMDA/EMA/FDA meetings. Minimum of five (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 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 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

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 The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem-solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.

We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Alexion is proud to be an Equal Employment Opportunity andAffirmative 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 is proud to be an Equal Employment Opportunity andAffirmative 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 [e-mail]. Alexion participates in E-Verify.