Global Clinical Head

AstraZeneca • Gaithersburg, MD

40d • Hybrid

About The Position

Are you a clinical research expert ready for new opportunities? Would you like to play a pivotal role in the development of potential medicines? If you are passionate about being a medical leader for a cross-functional team in a group that drives action towards the improvement of global public health– join us! As Global Clinical Head you will have a unique opportunity to further elevate the Vaccines and Immune Therapies franchise in one of the world’s most respected biopharmaceutical companies. The role holds a significant development opportunity for the successful candidate whilst contributing to the positive journey that AstraZeneca is on.
Accountabilities:
The Global Clinical Head (GCH) will have overall clinical leadership of one or more global teams and will deliver a portion of the Vaccines and Immune Therapies pipeline. The GCH is also responsible for medical/scientific strategies for the clinical components of the Target Product Profile (TPP), Clinical Development Plan (CDP), and regulatory documents (e.g., briefing documents, CTD/BLA, core labelling texts). Within the Clinical Project Team, the GCH has accountability for the clinical, scientific, and value content and delivery of the medical components for the program to time and quality. The GCH will be the team’s voice and representative on the Global Project Team that oversees the overall strategy of Infection products.

Requirements

• Graduate of a recognized school of medicine with an M.D. degree or equivalent.
• Demonstrated clinical research expertise in Infectious Diseases and vaccines
• Experience in early and late stage program development and trial conduct
• Demonstrated ability to lead the development of a program strategy and be accountable for project plans, timelines, progress, and outcomes.
• Global regulatory submissions, interacting with major Health Authorities, and experience with regulatory document writing and filings (e.g., NDA/BLA submissions, benefit/risk assessment)
• Demonstrated ability leading and motivating teams in a matrix environment.
• Demonstrated ability to lead, coach, and mentor physicians.
• Significant hands-on clinical drug development experience and scientific credibility.
• Developed/delivered in parallel, composed of multiple complex and large studies (e.g., including but not limited to multinational, pivotal Phase 3 efficacy studies).
• Demonstrated ability to cultivate excellent cross-functional collaborations.
• Demonstrated ability to effectively communicate at multiple levels of the organization.
• Must demonstrate high integrity.
• Organize and deliver Advisory Boards with international Key Opinion Leaders (KOLs).

Nice To Haves

• Named Investigator on a number of clinical trials.
• Years of pharmaceutical industry knowledge and experience.
• Progressed compounds into first time in human Phase 1 studies and Phase 2 delivery of proof of principle studies.
• Significant and consistent peer-reviewed publication track record.

Responsibilities

• overall clinical leadership of one or more global teams
• deliver a portion of the Vaccines and Immune Therapies pipeline
• responsible for medical/scientific strategies for the clinical components of the Target Product Profile (TPP), Clinical Development Plan (CDP), and regulatory documents (e.g., briefing documents, CTD/BLA, core labelling texts)
• accountability for the clinical, scientific, and value content and delivery of the medical components for the program to time and quality
• team’s voice and representative on the Global Project Team that oversees the overall strategy of Infection products

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees