The Senior Director of Clinical Development Medical Affairs (CDMA) is responsible for driving the strategic direction and execution of hepatology drug programs. This entails ensuring alignment with brand team objectives, integrating internal and external insights, and crafting an R&D plan that addresses unmet patient needs while fostering competitive differentiation and readiness for new indication/label approvals.
Responsibilities
Develop and align hepatology program strategy with R&D Leadership and Brand Team.
Lead risk mitigation and contingency planning, escalating risks as necessary.
Provide scientific, technological, and medical expertise for clinical research aspects of registration activities, contributing to the project strategy and clinical development plan (CDP).
Identify key opinion leaders/principal investigators to endorse the program's scientific basis and assumptions related to medical needs and clinical utility.
Interpret efficacy and safety data, seeking advice from experts as needed.
Oversee clinical study reports, expert reports, integrated summaries, and other regulatory documents.
Participate in interactions with regulatory authorities, including preparation for meetings and serving as the main scientific/medical representative.
Contribute to project publication plans and liaise with commercial teams on launch activities.
Stay informed about medical/scientific advancements and maintain relationships with external experts aligned with therapy area objectives.
Represent the company with outside groups and contribute to medical aspects of regulatory issues.
Manage budgets for CDMA activities.
Requirements
Advanced degree (PhD, PharmD, MD) with a specialty in hepatology/nephrology/critical care.
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 with global regulatory agencies.
Strong business acumen, balancing scientific standards with business impact.
Excellent communication, interpersonal, and leadership skills.
Ability to quickly learn about new subject areas and effectively communicate information.
Demonstrated ability to establish strong customer relationships.
Commitment to full compliance with company SOPs, laws, and regulations.
Preferred Qualifications:
Experience with medical device/drug device combination products.
Track record of successfully leading clinical development programs from concept to regulatory approval.
Seniority level
Executive
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Staffing and Recruiting
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