Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Medical Director/Medical Director in our Cambridge, MA 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 Futureto people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
- The Associate Medical Director/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. Applies clinical/medical decision making to clinical development issues.
- This individual interacts with and influences Takeda Global Research and Development Center (TGRD) and Takeda Pharmaceuticals Company senior leadership decision-making for the projects by setting strategic direction as part of the GI Therapeutic Area Unit (GI TAU). Success or failure directly translates to the ability of GI TAU to meet its strategic and operational research and development goals and for Takeda to have future commercial products that are innovative and differentiated to improve the health of patients.
- Clinical Development team participation and leadership
- Focus on gastrointestinal disorders and conditions in need of novel treatments from a medical and scientific perspective in early and/or late-stage development.
- Leads Global (US/EU) Clinical Sub-Team and oversees Japan & Asia Clinical Sub-Team to ensure that activities are aligned with global strategy.
- As a member of the Global Program Team (GPT), establishes and drives Clinical Sub-Team strategy and deliverables in the context of the GPT’s Asset Strategy. Leads the generation of Clinical Development Plan and Clinical Protocols.
- Provides therapeutic area scientific expertise in the assessment of internal and external opportunities for clinical research to address the unmet medical needs of patients with gastrointestinal conditions.
- 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. 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 GI DDU and GI Business Unit based on pertinent clinical and development expertise to provide knowledge / understanding of market environment in line with status as GI TAU scientific content expert for assigned compounds and clinical evaluations. May represent clinical science on multidisciplinary task forces across divisions. Lead TGRD 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.
- Coordinates, leads and delivers period department trainings including scientific literature reviews.
- EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- MD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, and/or biomedical/clinical experience within academia).
- Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions, and/or management experience
- NDA/MAA/Submission experience preferred.
- 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