Global Clinical Head, Respiratory

AstraZeneca • Boston, MA

1d • Hybrid

About The Position

The Global Clinical Head (GCH) is the most senior medical scientific expert on an asset/product/indication team and is a core member of the Franchise Team (if applicable) and/or the Global Product Team (GPT). This role will report to the Vice President Clinical Respiratory. This person will be accountable for all clinical scientific aspects of the product/asset, including the benefit/risk of a product and/or asset as well as the scientific strategies for clinical components of the Target Product Profile (TPP), Target Product Claim (TPC), Clinical Development Plan (CDP), Clinical components of regulatory documents and core labelling texts. Provide clinical and medical expertise input into overall project strategy. Will have accountability for the clinical deliverables i.e. clinical studies, clinical components of regulatory submissions etc to time. Serve as the single point of contact for TA-Heads and R&D leaders for clinical and scientific components of the product and/or indications.

Requirements

• An MD, or other equivalent medical degree from an accredited university with specialty training in Respiratory or related area.
• 7 years’ relevant experience within the respiratory space, including late-phase drug development experience.
• Demonstrated deep clinical and research expertise in appropriate disease area.
• Significant hands-on late phase clinical drug development experience.
• Developed/delivered multiple complex and large studies (e.g., including but not limited to multinational outcome studies).
• Scientific credibility internally and externally.
• Demonstrated success in influencing functions outside of clinical and across geographies.
• Experience of benefit/risk assessment and creating patient risk management plans.
• Experience of global regulatory submissions and interacting with major regulatory agencies.
• Demonstrated ability to successfully lead, coach, and mentor other physicians/scientists.
• Proven teamwork and collaboration skills in a global setting.
• Credible in scientific and commercial environments.
• Fit for purpose business acumen, and insight into payer and reimbursement hurdles globally.
• Line management experience.

Nice To Haves

• Global external awareness within the therapeutic area.
• Global regulatory awareness.
• Ability to travel nationally and internationally.
• Experience in several organizations and geographic locations.
• Experience of working with Market Companies to deliver studies/projects.
• Experience of clinical/commercial interface.

Responsibilities

• Accountable for all clinical scientific aspects of the product/asset, including the benefit/risk of a product and/or asset.
• Responsible for scientific strategies for clinical components of the Target Product Profile (TPP), Target Product Claim (TPC), Clinical Development Plan (CDP), Clinical components of regulatory documents and core labelling texts.
• Provide clinical and medical expertise input into overall project strategy.
• Accountable for clinical deliverables such as clinical studies and clinical components of regulatory submissions to meet timelines.
• Serve as the single point of contact for TA-Heads and R&D leaders for clinical and scientific components of the product and/or indications.
• Successfully lead, coach, and mentor other physicians/scientists.
• Influence functions outside of clinical and across geographies.
• Create patient risk management plans.
• Interact with major regulatory agencies.
• Work with Market Companies to deliver studies/projects.
• Manage the clinical/commercial interface.

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
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees