Global Medical Lead, Dermatology
Takeda · Massachusetts
📍 USA - MA - Cambridge - Kendall Square - 500via workday
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Job Description
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Global Medical Lead, Dermatology in our Cambridge office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
Role Summary
The Global Medical Lead, Dermatology, is responsible for driving the medical strategy and execution of dermatology late-phase clinical studies in global medical affairs, ensuring alignment with GPT, brand team, market access, and regulatory strategies. This role leads cross-functional teams, engages with key opinion leaders, and leverages digital innovation to advance dermatology research and patient care.
Primary Duties
• Leads and drives strategy and execution for the Dermatology company sponsored studies with focus on Ph3b/4 studies taking into consideration the medical, scientific, access, regulatory and commercial strategy for assigned compounds/indications.
• Leads a multi-disciplinary, multi-regional, matrix team and CRO through highly complex decisions. This individual interacts with and influences Medical Strategy Team (MST), Global Project Team (GPT), senior leadership in Global Medical, and Global Portfolio Division (GPD) for the projects by setting strategic direction.
• Collaborate with Global Medical Unit Head-Dermatology to develop a multi-year vision including Ph3b/4 plans for the product, providing scientific support aligned with the Global Project Team (GPT) and global brand strategy. This includes incorporating cross-functional strategies from Clinical, Commercial, PV, HEOR, Market Access, DD&T, Regions and countries/LOCs as appropriate.
• Develop the medical strategy, LCM and Ph3/b plans for assigned asset/indications in collaboration with the Medical Strategy Team (MST) and Evidence Team leveraging digital and technology-forward initiatives.
• Act as a Global Medical expert, steward, and custodian of scientific knowledge in collaboration with scientific communication partners.
• Establish strategic partnerships with Sites, Investigators, centers of excellence and key opinion leaders (KOLs) in areas of scientific interest.
• Leverage AI, machine learning algorithms and technologies in identifying solutions that can assist HCPs/dermatologists in making accurate diagnoses and treatment plans.
Responsibilities
Synopsis / Protocol Development, Study Execution, & Study Interpretation
• Support the strategy, design and execution of clinical studies (phase 3b/4, and contribute to disease registries, epidemiological studies, outcomes surveys, etc.) in collaboration with clinical science, biostatistics, Global Medical Evidence, GEO, and GPT as required.
• Drives global medical affairs activities relating to the preparation / approval of synopses, protocols and the conduct of Ph3b/4 clinical studies. Serves as an advisor to other team members involved in these activities and is accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determine how individual study results impact the overall compound strategy.
• Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
Trial Medical Monitoring
• Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual safety. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance. Oversees team with respect to assessment of these issues.
• Makes final decisions regarding study conduct related to scientific integrity.
• Leadership roles in developing documents required to outline the Company positions on studies, materials used for meeting presentations, responses to the regulatory organizations, opinion leaders. Lead roles will also be taken on the incorporation of advice / recommendations received into the design of clinical studies / programs as appropriate, accountable to senior leadership for the successful completion of related objectives.
• Co-lead the development of publication plan and data disseminations for the assigned studies, including posters, abstracts, manuscripts and symposia.
• Implement digital communication strategies and tools to effectively communicate scientific information and engage with healthcare professionals and patients such as digital newsletters and remote monitoring
• Interacts directly with research division, early clinical and clinical scientist, based on pertinent clinical and development expertise to provide knowledge / understanding of market environment for assigned compounds.
• Help develop and implement the Global Medical Affairs (GMA) strategy for defined products, aligned with product strategy and regional/local strategies.
• Develop and integrate digital therapeutic solutions that provide evidence-based interventions for managing chronic skin conditions. These can include interactive programs, behavioral therapy mod
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