Head of Medical Affairs

Pliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic diseases. As the leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, Pliant is developing small molecule drug candidates specifically designed to impact the fibrotic process.

The Company’s lead product candidate, bexotegrast (PLN-74809), is an oral small molecule, selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant is currently conducting BEACON-IPF, a Phase 2b/3 trial of bexotegrast for the treatment of IPF and INTEGRIS-PSC, a Phase 2a trial of bexotegrast for the treatment of PSC.

Pliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. The Company also has discovery and development programs in oncology and muscular dystrophies.

Description

Reporting to the Chief Medical Officer, the Head 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 candidate 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.
• Identify relevant medical meetings and congresses; develop and execute on Medical Affairs strategies and determine appropriate participation to ensure strong medical and scientific presence.
• 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.
• 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 pulmonary fibrosis (IPF and/or ILD) and/or highly adjacent rare pulmonary discipline (e.g, PAH)
• Experience with building Medical Affairs function in preparation for launch
• US launch experience is required; global launch experience 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
• Ability to travel domestically and internationally ~25%
  
  

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.

To understand how Pliant complies with and manages your personal information with respect to the California Consumer Privacy Act, please visit https://pliantrx.com/ccpa-applicant-and-staff-privacy-notice/.