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 Medical Director, Clinical Science, GI2 TAU 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.
ACCOUNTABILITIES:
- Represents Clinical Science on Project or Clinical Teams and may serve as the Clinical Science leader on these teams
- Supports the Global Project Team to ensure that the clinical team activities are aligned with the global strategy
- Contributes to the overall Asset Strategy by supporting the development of the Clinical Development Plan, leads the development of Clinical Protocols and other documents needed for CDP and study execution and regulatory submissions. Recommends scope, complexity and size, and influences the budget of all aspects of a study
- 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.
- 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/or commercial viability of a product.
- Synopsis / Protocol Development, Study Execution, & Study Interpretation
- Drives Clinical Science department 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 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 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 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.
- Directs activities involved in interactions with regulatory authorities/agencies and clinical development and key opinion leaders relevant to assigned compounds. Provides leadership and serves as an advisor to the other clinical scientists engaged in these activities and, in the context of these responsibilities, will be 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, conducts 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 interfaces with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner. Provides guidance to clinical scientists who are involved in some of these activities.
- Leadership, Task Force Participation, Upper Management Accountability
- Interacts directly with research division based on pertinent clinical and development expertise.
- May represent clinical science on multidisciplinary task forces across the organization or external to the company.
- May lead global cross-functional teams as appropriate.
- Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities.
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). Subspecialty in Hepatology or Immunology highly preferred. Experience and knowledge of alpha-1 antitrypsin deficiency a plus.
- Phase 3 Clinical Trial experience preferred
- Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.
- NDA/MAA/Submission and launch experience preferred
- Management experience preferred
_Skills_
- 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
_Knowledge_
- Therapeutic area knowledge relevant to mechanisms of action of compounds in remit
- Regional/global Regulatory requirements
- GCP/ICH
- Emerging research in designated therapeutic area
_Travel requirements_
- 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
This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
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