Reporting to the Chief Medical Officer, the Vice President of Medical Affairs will be responsible for designing Medical Affairs strategy and building out the Medical Affairs organization, supporting the transition of the company from Research and Development organization to a commercial organization. This person will oversee Medical Affairs including development of strategies and supporting execution for sub-functions (Strategy and Operations, Field Medical Affairs, Medical Communications and Publications, Patient Advocacy, health pharmacoeconomic and outcomes research (HEOR)). The VP has broad experience across multiple functions within Medical Affairs, the ability to interact with senior leadership and cross-functionally, and a proven track record of successful launches in the US and globally.

This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco).

Responsibilities

• Build Medical Affairs leadership including developing strategic plans, evaluating specific unmet medical needs, and creating results-oriented plans to fill medical product data gaps in rare diseases.
• Responsible for building and overseeing the Medical Affairs team, including MSLs, Medical Communication and Publications, Medical Information, Patient Advocacy, and HEOR.
• Provides medical/clinical expertise to internal (Commercial, Manufacturing, Market Access, Regulatory, R&D, and Legal) and external (healthcare professionals, patients, advocacy groups, etc.) stakeholders.
• Collaborate with cross-functional teams to drive development plan and brand strategy, ensuring alignment and compliance in messaging and communication strategy.
• Partner with Clinical Development and Clinical Operations to provide support for clinical studies (recruitment, engagement, study design, and endpoint selection) and ensure Medical Affairs contribution to development activities, including medical input on patient reported outcome measures to pivotal study design.
• Partner with R&D and program teams to provide medical input into early pipeline prioritization.
• Develop and manage clinical advisors and KOL relationships, assist in the selection of outside experts and maintain key relationships around clinical trials, guidelines, and advisory boards; oversee engagement activities nationally and globally.
• Develops and delivers scientific and medical presentations, organizes and leads medical affairs advisory boards, participates in investigator meetings, provides medical support to commercial advisory boards.
• Identify relevant medical meetings and congresses; develop Medical Affairs strategies and determine appropriate participation to ensure strong medical and scientific presence.
• Collaborate with future commercial teams (eg, Sales and Marketing teams) with therapeutic area and drug-related materials, training, and educational updates.
• Collaborate with stakeholders to develop early access strategy and plan, accountable for effective execution of early access plan.
• Develop an integrated evidence generation plan for life-cycle strategy; partner with Clinical Development, Regulatory and Pharmacovigilance on execution of Phase IV studies and registries.
• Create and facilitate submission/review processes for Investigator Initiated Studies (IIS), materials approval, grants, and publications.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities and prior experience required.

• MD, PhD, PharmD, or equivalent degree, with 15+ years of experience in the pharmaceutical/biotech industry in Medical Affairs and at least 8+ years in leadership roles.
• Experience with building Medical Affairs function in preparation for launch.
• US launch experience is required; launch experience in ex-US region is a plus.
• Capable of managing shifting priorities in a rapidly changing and highly competitive environment.
• Demonstrated ability to present complex scientific and medical information to a range of audiences; ability to represent the needs of a broad range of stakeholders in development of real-world evidence strategy and approach.
• A proven track record of strong writing and reviewing skills that are compliant with legal, requirements, local policies and procedures, including Good Publication Practices.
• Experience with building and development effective relationships with key opinion leaders and external partnerships.
• Excellent interpersonal skills with a demonstrated track record of achieving results and optimizing team performance.
• Demonstrated reputation as a well-respected, dynamic team leader with strong leadership and people management skills.
• Experience with pulmonary fibrosis and/or rare disease preferred.
• Ability to travel domestically and internationally ~25%.

Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

The annual base salary for this role is $370K – $390K. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.