- Lead the Gastroenterology team, and the GI Integrated Evidence Team Leader, in developing a scientifically, strategically, and commercially sound strategy of evidence generation to support all 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 a matrixed team capable of determining ongoing scientific strategies and tactics. Create opportunities for key talent to assume 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 contribute as a disease-specific subject matter expert and 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 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 and subject matter expertise for regulatory requests.
- Serve as a key 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.
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Senior Director, Strategic Lead US Medical Affairs Gastroenterology - Horsham, United States - Johnson & Johnson
Description
Johnson and Johnson is recruiting for a Senior Director, Strategic Lead US Medical Affairs Gastroenterology located in Horsham, PA.At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at .As Immunology Leaders, we know immunology is vital to human health.
Driven by a relentless focus on patient unmet needs, we will redefine treatments for immune diseases by delivering transformational and accessible therapies and regimens to patients with immune-mediated disease.
For more than two decades we have been a world leader in the development of transformational medicines, establishing one of the strongest, first-in-class portfolios and pipelines in the industry, including the first tumor necrosis factor (TNF) inhibitor, and first interleukin (IL)-12 and IL-23 inhibitors.
We tirelessly push the boundaries of science and creativity, applying our deep disease insights, novel pathway science, new technologies, and treatment modalities to restore immune homeostasis.
The Senior Director, Strategic Lead US Medical Affairs Gastroenterology is responsible for supervising a matrixed team advancing the scientific strategy and business plan for the Gastroenterology Therapeutic Area (TA).
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.