Global Clinical Head, Rheumatology

Role Summary

The Global Clinical Head is the most senior medical scientific expert on an asset/product/indication team and is a core member of the Franchise Team and/or the Global Product Team. Location: Boston, MA.

Responsibilities

• 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, Target Product Claim, Clinical Development Plan, 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
• 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

Qualifications

• Required: An MD, MBBS, or other equivalent medical degree from an accredited university
• Required: Minimum 7 years’ relevant experience within the immunology, rheumatology, allergy, or autoimmune space, including late-phase drug development experience.
• Required: Developed/delivered multiple complex and large studies (e.g., multinational outcome studies).
• Required: Demonstrated success in influencing functions outside of clinical and across geographies.
• Required: Experience of benefit/risk assessment and creating patient risk management plans.
• Required: Experience with global regulatory submissions and interacting with major regulatory agencies.
• Required: Demonstrated ability to successfully lead, coach, and mentor other physicians/scientists.
• Required: Excellent communication skills across stakeholder groups.
• Required: Fit for purpose business acumen, and insight into payer and reimbursement hurdles globally
• Preferred: Global external awareness within the therapeutic area.
• Preferred: Global regulatory awareness.
• Preferred: Ability to travel nationally and internationally.
• Preferred: Experience in several organizations and geographic locations
• Preferred: Experience of working with Market Companies to deliver studies/projects.
• Preferred: Experience of clinical/commercial interface.