Associate Medical Director/Medical Director, Clinical Science - GI:
Takeda Pharmaceutical

1548406400
Takeda Pharmaceutical
Brockton Massachusetts
Pharmaceutical
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Description
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Job Description
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 Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

POSITION OBJECTIVES:
  • The Associate Medical Director/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.Responsible 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.
  • Interacts with and influences Takeda GI senior leadership decision-making by setting strategic direction. Success or failure directly translates to the ability of Takeda GI to meet its corporate goals and for Takeda to have future commercial products.
POSITION ACCOUNTABILITIES:
  • Clinical Development team participation and leadership
  • Represents Clinical Science on US/EU Development Teams and will serve as leader of this team. 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 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.
  • 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 DD visits and alliance negotiations and represents clinical science on internal assessment teams in conjunction with TPNA/TPEU/TPC. For ongoing alliance projects, will interface with partner to achieve Takedas strategic goals while striving to maintain good working relationship between Takeda and partner.
  • Leadership, Task Force Participation, Upper Management Accountability
  • Interacts with research division based on pertinent clinical and development expertise and with TPNA/TPEU to provide knowledge / understanding of market environment in line with status as TGRD scientific content matter expert for assigned compounds. Represents clinical science and leads internal task forces and TGRD 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, BEHAVIORAL COMPETENCIES AND SKILLS:
  • MD or internationally recognized equivalent 3 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
  • 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 mechanism of action
  • Regional/global Regulatory requirements
  • GCP/ICH
  • Emerging research in designated therapeutic area
Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.
  • This job posting excludes CO applicants.
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
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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..... click apply for full job details