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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.
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 modules, and educational content.
Interaction with internal and external stakeholders in alignment with customer needs and medical strategy:
Represent the company with external scientific leaders, study investigators, policymakers, patient advocacy groups, and regulatory authorities.
Develop and prioritize a global KOL engagement strategy for the respective diseases.
Establish and enhance partnerships with key Dermatology academic institutions and thought leaders.
Represent Medical Affairs at internal and external meetings, plan, design, and manage medical advisory boards.
Present data on products and therapeutic areas.
Maintenance of knowledge base:
Serve as a key medical resource on dermatology and specific programs, ensuring the dissemination of up-to-date scientific knowledge across the organization.
Maintain a high level of expertise in dermatology, psoriasis, and related therapeutic areas, staying abreast of the latest research, clinical guidelines, and treatment advancements.
Continuously update knowledge of GCP. ICH guidelines, global pharmaceutical regulations, guidelines, codes of practice, and company policies related to medical activities.
Develop and conduct comprehensive therapeutic training programs for internal departments, ensuring that all team members are well-informed about the studies, latest developments in psoriasis and dermatology.
Foster a culture of continuous learning and professional development within the medical team, encouraging participation in relevant conferences, workshops, and training sessions.
Collaborate with external experts and key opinion leaders to stay informed about emerging trends and innovations in dermatology.
Utilize digital tools and platforms to facilitate the efficient sharing and updating of medical knowledge within the organization such as digital visualization tools.
Maintain a curious and open-minded mindset towards new technologies and innovations. Be willing to explore and experiment with new ideas to help stay ahead of the rapidly evolving field of technology, AI, and digital.
Education and Experience Requirements:
A Medical degree MD, DO, MBBS is required. Additional degrees in life science (PhD, MPH) will be a plus.
5-8 years of experience in biopharmaceutical medicine, leading clinical studies in late development in pharmaceutical companies, academia or CRO.
Experience in late clinical development, medical monitoring of clinical studies, and managing CRO, is required.
Experience in immunology, dermatology, and/or psoriasis through clinical experience, biopharmaceutical experience, or education is preferred.
Certification in digital health, AI or experience in leveraging AI and machine learning.
Knowledge of GCP, ICH and global pharmaceutical regulations and guidelines.
Experience working in cross-functional teams at the brand or disease area levels in country, regional, or global organizations is preferred.
Key Skills, Abilities, and Competencies:
Demonstrated strategic and operational skills in leading large late-stage developmental programs including ph3b/4 studies.
Ability to think strategically and tactically from a medical perspective to support the overall evidence plan to launch a brand.
Expertise in study designs, writing protocols, analysis and reporting data, writing study reports and publications.
Expertise in utilizing data analytics and AI to drive evidence-based decision-making, optimize clinical trial design, and improve patient outcomes.
Strong understanding of digital communication strategies and tools to effectively communicate scientific information and engage with healthcare professionals and patients.
Experience in leveraging digital health technologies, including telemedicine, mobile health applications, and wearable devices, to enhance patient care and engagement.
Ability to work in a global environment across diverse cultures and collaborate cross-functionally.
Excellent written and verbal communication skills.
Ability to manage the matrix teams and drive initiatives without direct line management authority.
Good analytical skills as applied to medical, scientific, and technical information.
Unquestioned ethics are a must.
Complexity and Problem Solving:
Innovative Thinking: Ability to develop and implement creative solutions to complex medical and strategic challenges, particularly in the context of digital health and dermatology.
Data-Driven Decision Making: Proficiency in utilizing data analytics and AI to inform strategic decisions, optimize clinical trial designs, and improve patient outcomes.
Cross-Functional Collaboration: Strong ability to work collaboratively with diverse teams across different functions, including clinical, commercial, regulatory, and digital health.
Adaptability: Capacity to adapt to rapidly changing environments and emerging technologies in the field of dermatology and digital health.
Strategic Planning: Expertise in developing and executing long-term strategic plans that align with the overall goals of the organization and the specific needs of the dermatology portfolio.
Risk Management: Ability to identify, assess, and mitigate risks associated with clinical trials, regulatory compliance, and market access.
Stakeholder Engagement: Proficiency in managing relationships with internal and external stakeholders, including key opinion leaders, regulatory authorities, and patient advocacy groups.
Problem-Solving Skills: Strong analytical and critical thinking skills to address complex medical and operational issues effectively.
Project Management: Expertise in managing multiple projects simultaneously, ensuring timely and successful completion of objectives.
Technological Proficiency: Familiarity with digital health technologies, including telemedicine, mobile health applications, wearable devices, and digital therapeutics.
Internal and External Contacts:
Accountable to GMUH-Dermatology.
Internal: Medical Strategy Team (MST), Evidence Generation Team (EGT), Publication commercial, market access, PV, DD&T, and other sub-teams.
External: academic, professional, regulatory, policy, patient advocacy leaders, strategic vendor partner
Other Job Requirements:
Availability to travel approximately 30% of time.
Some activities may call for early or late meetings at different time zones and attendances at scientific meetings on holidays and weekends.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MAU.S. Base Salary Range:
$228,200.00 - $358,600.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.