Senior Director, Clinical Development - Hepatology

Position Overview: The Senior Director of Clinical Development in Medical Affairs spearheads the strategic direction and oversight of the hepatology drug program execution for an established Pharmaceutical company with over 150 years industry, a very exciting program and great time to join the growing business.

The Snr Director will ensure alignment with brand team objectives, integrate pertinent internal and external insights, and craft an R&D roadmap aimed at meeting unmet patient needs, fostering competitive distinction, and facilitating preparations for new indication/label approvals.

Key responsibilities:

• Collaborates with R&D Leadership and Brand Team to develop, agree upon, and align hepatology program strategy.
• Takes charge of risk mitigation and contingency planning, escalating risks when necessary.
• Offers scientific, technological, and medical expertise for clinical research aspects of registration activities, integrating regulatory affairs knowledge into project strategy and clinical development plan development.
• Interaction with regulatory authorities.
• Assumes a pivotal role in identifying key opinion leader(s)/principal investigators.
• Provides medical and scientific interpretation of efficacy and safety data, seeking advice from other experts when needed.
• Holds accountability for clinical study reports, including expert reports, integrated summaries, and other regulatory documents.

Qualifications:

• Advanced degree (PhD, PharmD, MD) with specialty in hepatology/nephrology /critical care required.
• 10+ years' pharmaceutical experience in Program Management, Clinical Development and/or Medical Affairs.
• Experience in clinical study/protocol/program design and execution.
• Ability to work effectively in a multidisciplinary team.
• Experience working with global regulatory agencies.

Location: This position is based on the East Coast and offers the flexibility of a home-based work arrangement, with occasional travel to our client's site.

If you have the above qualifications, and interested in a further conversation about the benefits of this opportunity, and are curious to know if this is your next career step, please apply with your CV and I will aim to contact you within 48 hours.