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 a Medical Director/Senior 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 Medical Director/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; applies clinical/medical decision making to clinical development issues. 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. Reports directly to the Head of Clinical Sciences, Rare Genetics and Hematology or designee with matrix reporting to the Global Program Leads for assigned programs. This individual interacts with and influences Takeda Global R&D and Takeda Pharmaceutical Company senior leadership decision-making by setting strategic direction for assigned projects.
POSITION ACCOUNTABILITIES:
Clinical Development team participation and leadership Leads the Global (US/EU) cross-functional Clinical Sub-team working closely with TDC-Asia and TDC-Japan to build and execute on a global program for a given product. Seeks Clinical Science functional alignment and represents Clinical Science on the Global (US/EU) Project Team to ensure that activities are aligned with the global strategy and key stakeholders Establishes and drives Clinical Development strategy and deliverables contributing to the Asset Strategy, the Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, and influences the budget for all aspects of a program. Provides 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. May oversee medical monitors and clinical scientists in the execution of the clinical development plan and clinical trials, providing mentoring, development opportunities, insights and support Monitors and interprets 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.
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 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, clinical data quality, and 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 Works cross-functionally and collaboratively with team members on 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 May be asked for participation in the identification and evaluation of potential business development opportunities, conducting due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and in-licensing opportunities. Responsibilities may include assessment of 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. May be asked to serve 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 research division based on pertinent clinical and development expertise and with commercial to provide knowledge / understanding of market environment in line with status as scientific content matter expert for assigned compounds. May represent clinical science on multidisciplinary task forces across divisions Lead 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 drives goal setting and development planning.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
MD or internationally recognized equivalent plus 5-10 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 desired. Management experience.
Skills
Superior communication, strategic, interpersonal and negotiating skills Ability to proactively predict issues and solve problems Ability to drive decision-making within multi-disciplinary, multi-regional, matrix teams Diplomacy and positive influencing abilities
Knowledge
Therapeutic area knowledge (neurology, rare diseases, pediatrics) relevant to mechanism of action is desired Passion for research is essential Clinical trialist experience/knowledge is essential Lifelong learner Understanding of regional/global regulatory requirements is desirable 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:
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