Gastroenterology Therapeutic Area Lead, US Medical Affairs – Immunology

Role Summary

The Gastroenterology Therapeutic Area Lead, US Medical Affairs - Immunology is responsible for supervising a matrixed team advancing the scientific strategy and business plan for the Gastroenterology Therapeutic Area (TA). The role will also manage a team of direct reports. The strategic arms are to strive for Medical Affairs leadership in this therapeutic area by identifying and addressing key stakeholders’ needs through data generation, data dissemination, and special initiatives supporting our Gastroenterology products. Based in Horsham, PA.

Responsibilities

• Lead the Gastroenterology Medical Affairs team including the GI Integrated Evidence Team Leader, in developing a scientifically, strategically, and commercially sound strategy of evidence generation to support all approved and late development Gastroenterology assets.
• Identify, prioritize, and oversee the implementation of innovative and compliant data dissemination approaches and data generation strategies, with cognizance of the continually changing healthcare environment and clinical practice patterns.
• Drive the execution of the Gastroenterology Therapeutic Area strategy through collaboration with functional areas (including R&D and Commercial) and ensure the strategy is aligned and successfully executed across global medical affairs, GI MSL, publications, marketing, and market access teams
• Lead both Gastroenterology Therapeutic Area employees and matrixed team partners in developing sophisticated and innovative scientific strategies, data generation activities and subsequent tactics. Create opportunities for key talent to assume future leadership roles.
• Supervise the planning and execution of Phase 3b and 4 clinical trials, studies to address post marketing commitments, and the development of other evidence generation activities (such as those using RWE approaches), as well as the assessment, coordination and prioritization of collaborative and IIS studies.
• Actively lead as a subject matter expert (SME) on internal and competitor data in relevant GI diseases and manage expertise on the GI MA team to provide advice and input to and support the Global Medical Affairs, R&D, Marketing, Sales, Market Access, New Business Development, Real World Value & Evidence, MSL, Medical Information, and Communications teams, shaping and influencing the collective strategy based on sound scientific principles, available data, and strategic insights.
• Lead the Gastroenterology Therapeutic Area in annual business planning and be responsible for budget decisions within boundaries allocated by the Medical Affairs Leadership Team. Serve as a core member of Medical Affairs Leadership Team, US Immunology Business Operations Leadership Team, and GI Integrated Strategy Team, and also serve as a co-lead of the GI Integrated Evidence Team.
• Represent US Medical Affairs in various interactions with the global functions including clinical R&D, translational medicine, regulatory affairs/labelling, and global medical safety. This includes providing data, responses, and subject matter expertise for regulatory requests and documents, directly and through the team.
• Serve as a key SME and driver of strategy and execution of publications from both the global and US perspectives. Provide strategic and scientific input on business development opportunities, pipeline assets (and related supportive clinical studies) to ensure necessary scientific rigor in study design and endpoints, as well as alignment with US strategic requirements.

Qualifications

• MD/DO degree required
• A minimum of 10 years of combined Immunology and/or Gastroenterology/hepatology clinical and/or industry experience, with at least 5 years in industry is required
• Gastroenterology or Immunology industry experience, including in clinical research/clinical trials is highly preferred; Medical Affairs experience highly preferred
• Experience in Immunology or a related field is required; Gastroenterology experience is highly preferred
• Previous direct people management experience is highly preferred
• The successful candidate must have strong leadership skills with highly collaborative instincts
• Experience in a multi-functional matrix organization is preferred
• Ability to communicate clearly and effectively with basic and clinical scientists, as well as with regulatory and commercial colleagues is required
• Excellent oral and written communication and presentation skills are required
• Up to 25% travel (primarily domestic & limited international) is required
• This position is located in Horsham, PA and follows a hybrid schedule of three days in the office and two days remotely per week