Job Title

Requisition

Location

Additional Locations

Job Description

The Senior Director, Clinical Development Medical Affairs (CDMA) drives strategy and accountability for the hepatology drug program execution, ensuring alignment with brand team objectives, incorporation of relevant internal and external insights and the generation of an R&D plan that delivers for unmet patient need, generates competitive differentiation, and prepares for new indication/label approvals. TheSenior Director, CDMA leads a multi-disciplinary program team effectively and efficiently through the Stage Gate process as required.

This leader is responsible for the strategic direction, planning, execution, and oversight of our clinical development programs, ensuring they meet the highest scientific and regulatory standards. They will also play a key leadership role in developing and implementing medical affairs strategies to support product launches and lifecycle innovation.

Continually seeks to increase clinical/scientific awareness and expertise by fostering relationships with outside organizations/experts to support research programs and licensed product maintenance and optimization. This includes leading Advisory Board and Expert Panel meetings, and providing strategic direction on Medical Education Grants, External Collaborative Research and Medical Publications.

• Develops, agrees and aligns on hepatology program strategy with R&D Leadership and Brand Team

• Leads risk mitigation and contingency planning; escalates risks as needed.

• Provides scientific, technological and medical knowledge and expertise for the clinical research aspects of registration activities with a working knowledge of regulatory affairs, in the development of the project strategy and the clinical development plan (CDP).

• Plays a primary role in identifying key opinion leader(s)/principal investigators for the program to ensure adequacy of the program's scientific basis and obtain endorsement on the assumptions related to medical needs and clinical utility represented in the project development strategy.

• Provides medical and scientific interpretation of efficacy and safety data; and to seek advice of other experts as required.

• Accountable for the clinical study reports including expert reports, integrated summaries, and other regulatory documents, etc.

• Plays a key role in the interactions with regulatory authorities (e.g., US Food and Drug Administration [FDA], European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA] meetings). This includes developing key documents, participating in the preparation for meetings with the health authorities, and participating in the meetings and interactions with the health authorities. To serve as the main scientific/medical representative during these interactions, with support from other project team members as needed.

• Provides input for a project publication plan; may author/review/approve content used for publications and promotions.

• Liaises with commercial on launch activities, if applicable

• Keeps abreast of current medical/scientific progress and actively develops and maintains relationships with outside experts aligned with the scientific and business objectives of assigned therapy area.

• Represents the company with outside groups. Works to understand the evolving healthcare environment (provider/expert) and payer landscapes and translates that working knowledge into a plan.

• Contributes to Medical aspects of Regulatory issues related to development compounds or marketed products including labeling discussions/updates, interactions with Regulatory Agencies, and Annual NDA and IND Report submissions.

• Participates in the Promotional Review Committee, Medical Review Committee, Grant Review Committee and Scientific Review Committee.

• Manages the respective budgets for assigned CDMA activities.

Minimum Requirements

• 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.

• Demonstrated business acumen with ability to balance need for maintaining high scientific standards with business relevance and impact.

• Excellent communication, interpersonal and leadership skills.

• Ability to quickly and comprehensively learn about new subject areas and environments and effectively communicate that information.

• Demonstrated ability to establish strong customer relationships.

• Focus on patient and external customers.

• Committed to full compliance with company SOPs, all applicable laws and regulations.

Preferred Qualifications:

• Experience with medical device/drug device combination products.

• Proven track record of successfully leading clinical development programs from concept to regulatory approval.

Organizational Relationship/Scope:

This position reports to VP, CDMA with a dotted line reporting relationship to the CSO. The Senior Director CDMA will interact with internal colleagues in Research and Development (Clinical Development & Medical Affairs, Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs, Pharmacovigilance) Strategy/Portfolio Management, Commercial and Operations functions. External collaboration includes trade associations, professional societies, payers, clinicians, and policy thought leaders, and various government personnel and agencies.

Usual office conditions in a hybrid environment (2 days/in office, 3 days remote); both domestic and international travel, 20-30%.

**Will consider Remote candidates.**