Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, neuroscience and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
Our US Offices are in Cambridge, MA. Research & Development employees in our Cambridge location focus on oncology, gastroenterology, immunomodulation, biologics, translational research, and external innovation. In March 2016, we opened our newest space at 300 Massachusetts Avenue, featuring 230,000 square feet of state-of-the-art office and lab space.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients lives. If you are driven to create better health and a brighter future, join us!
The Senior Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda pipeline compounds. Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the ultimate responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned compound in multiple regions as well as inform the value dossiers required for reimbursement. Applies clinical/medical decision making to clinical development issues. This individual interacts with and influences Oncology Therapeutic Area Unit and Takeda R&D senior leadership decision-making for the projects by setting strategic direction. Success or failure directly translates to the ability of Takeda R&D to meet its corporate goals and for Takeda to have future commercial products.
- Clinical Development team participation and leadership
- Focus on one asset (TAK-164), with the intent of supporting others, preferably in the area of gastrointestinal malignancies.
- Leads Global (US/EU/Japan) Clinical SubTeam and oversees Japan & Asia Clinical SubTeam to ensure that activities are aligned with the global strategy.
- As a member of the Global Program Team (GPT), establishes and drives Clinical SubTeam strategy and deliverables in the context of the GPT s Asset Strategy; leads the generation of the Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, and influence the budget of all aspects of a program. Provides continual critical evaluation of the Asset Strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
- Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development such as go/no go decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. A significant error in judgment may result in loss of approvability and commercial viability of a product.
- Synopsis / Protocol Development, Study Execution, & Study Interpretation
- Drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to other clinical scientists 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 subject safety, in partnership with CRO responsible for trial delivery. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to assessment of these issues.
- Makes final decisions regarding study conduct related to scientific integrity.
- External Interactions
- Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas. These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or 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.
- Due Diligence, Business Development and Alliance Projects
- Responsible for identification and evaluation of potential business development opportunities, conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities. Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams.
- Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda s strategic goals while striving to maintain good working relationship between Takeda and partner.
- Leadership, Task Force Participation, Upper Management Accountability
- Interacts directly with Oncology DDU and Oncology Business Unit based on pertinent clinical and development expertise to provide knowledge / understanding of market environment in line with status as OTAU scientific content matter expert for assigned compounds. May represent clinical science on multidisciplinary task forces across divisions. Lead Takeda R&D internal teams and may lead global cross-functional teams, as appropriate.
- Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning.
- Coordinate, lead and deliver periodic departmental trainings.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- MD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
- Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.
- NDA/MAA/Submission experience preferred.
- Management experience
- Superior communication, strategic, interpersonal and negotiating skills
- Ability to proactively predict issues and solve problems
- Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
- Diplomacy and positive influencing abilities
- Therapeutic area knowledge relevant to mechanism of action
- Regional/global Regulatory requirements
- Emerging research in designated therapeutic area
- Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 15 - 25% travel.