Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Medical Director / Global Program Lead - GI Motility 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 Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission. As a Medical Director, GI Motility team member, you will be empowered to contribute to Takeda s mission.
The Medical Director leads and drives strategy for the overall regional (US/EU) clinical development taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda pipeline compound(s). Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a clinical development plan that will result in the regulatory approval of the compound in multiple regions. Applies clinical/medical decision making to clinical development issues. This individual interacts with the different line functions and works closely with Global Program Leads and Global Program Managers to set the asset strategic direction for the asset. Success or failure directly translates to the ability of the GPT and the TAU to meet its corporate goals and for Takeda to have future commercial products.
- Clinical Development team participation and leadership
- Represents Clinical Science on US/EU Development Teams and will serve as leader of this team in the GPT. Supports the Global Development Team (US, EU, Japan) to ensure that the US/EU Development Team activities are aligned with the global strategy. May act as Global Development Team (US, EU, Japan) Leader managing both the US/EU Development Team and the Japan Development Team for an early or a smaller scope product.
- Responsible for development team strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, and influence the budget of all aspects of a program. Ongoing work output will involve continual critical evaluation of the development 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. Recommends high impact global decisions. Responsible for 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/or commercial viability of a product.
- Synopsis / Protocol Development, Study Execution, & Study Interpretation
- Oversees all 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 be accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determines 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 Global Patient Safety lead. 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 interactions with key opinion leaders relevant to assigned compounds and therapeutic area. Provides leadership in meetings and negotiations with 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. Leads incorporation of advice / recommendations received into the design of clinical studies and programs as appropriate.
- Due Diligence, Business Development and Alliance Projects
- Responsible for evaluation of potential business development opportunities and conduct of due diligence evaluations assessing scientific, medical and development feasibility, evaluating complete or ongoing clinical trials, and regulatory interactions and future development plans.
- Contributes to the development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities, interacts with upper management of potential partner/acquisition companies during due diligence visits and alliance negotiations and represents Clinical Science on internal assessment teams. For ongoing alliance projects, will 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 with the Drug Discovery Unit (DDU) based on pertinent clinical and development expertise and with Commercial and Global Insights to provide knowledge / understanding of market environment in line with status as subject matter expert for assigned compounds. Represents Clinical Science and leads internal teams as well as 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.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- MD or internationally recognized equivalent plus at least 3 years of clinical research experience within the pharmaceutical industry and CRO health-related consulting company (or a combination of afore mentioned).
- Preferred, but not required, Board certified/ or international equivalent in Gastroenterology or Previous Drug Development experience in Gastroenterology
- Superior communication, writing, 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 (Gastroenterology/ GI motility)
- Familiar with Regional/global Regulatory requirements,
- Familiar with GCP/ICH
- Basic knowledge of Biostatics to facilitate design and interpretation of clinical trials
- Ability to travel, including overnight trips. Some international travel may be required.
- Requires approximately 10 - 20% travel.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.