Senior Global Clinical Operations Program Director

AstraZeneca • Gaithersburg, MD

162d

About The Position

Do you have expertise in Clinical Operations, and a passion to support strategy development and delivery of Clinical Development Programs? If yes, then we are recruiting a Senior Global Clinical Operations Program Director within the Vaccines and Immune (V&I) Therapies Clinical Operations group. Biopharmaceuticals Clinical Operations is a diverse, international team focused on the end-to-end design, planning and delivery of patient-centric clinical trial programs and studies, enabling submissions for the AstraZeneca portfolio. We work throughout the clinical lifecycle and leverage our expertise to design and deliver sustainable trials with short clinical cycle times and an excellent patient experience. The Vaccine and Immune Therapies unit is committed to protect and treat the most vulnerable populations, through development of vaccines and/or monoclonal antibodies. We are focused on developing medicines that provide an effective and long-lasting immunity.

Requirements

• Bachelor's degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research; advanced degree is preferred.
• Extensive experience within pharmaceutical industry or similar biotech global industry.
• Extensive global experience of clinical development/drug development process across early/late phase.
• Experienced in use of project management techniques and systems for complex projects.
• Clinical operations expert level knowledge in study and program leadership roles.
• Extensive global drug development leadership experience.
• Proven teamwork and ability to work collaboratively across a wide range of disciplines.
• Strong strategic communication skills and an ability to influence broadly within and outside the organization.

Nice To Haves

• Demonstrated ability to drive process improvement and/or functional work.
• Experience in vaccine development/clinical trials or working in infectious disease area.
• Regulatory submission experience.
• Experience of implementing changes in ways of working that focus on increasing efficiency.
• Experience in development and implementation of digital health and patient centric strategies into clinical studies.
• Proven experience in leading teams through change.

Responsibilities

• Accountable for input into the design and delivery of the clinical development plan.
• Provide strategic and operational leadership within Clinical Operations V&I.
• Integrate strategy, feasibility and operational planning to produce business-focused clinical drug development programs.
• Interact with senior leaders within AZ.
• Lead the delivery of a program of studies and manage project management of clinical support for regulatory marketing applications.
• Support design, set-up and delivery of clinical development plans as leader of the Clinical Program Team (CPT).
• Ensure provision of timelines and budget relating to clinical development plan.
• Provide clinical operations expertise into the program and for the use of new innovative design and delivery models.
• Responsible for efficient and effective program management covering all clinical development deliverables.
• Represent wider Biopharmaceutical Clinical Operations functions at CPT/GPT and required Governance interactions.
• Provide leadership, clear direction and aligned goals to clinical delivery teams.
• Manage program-level AZ operational interface with externally managed/outsourced partners.
• Contribute to functional and cross functional initiatives as Subject Matter Expert.
• Coach and mentor the Global Clinical Operations Program Director (GPD).

Benefits

• Flexible working environment with a minimum of three days per week in the office.
• Opportunities for career development and skill expansion.
• Commitment to protecting patients, people, and the planet.
• Culture rooted in integrity, inclusiveness, and dedication to supporting communities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree