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Sr Medical Director Clinical Science, Rare Genetics and Hematology (RGH) Therapeutic Area Unit (TAU)

Cambridge, Massachusetts


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Sr Medical Director Clinical Science, Rare Genetics and Hematology (RGH) Therapeutic Area Unit (TAU)

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Job ID R0036247 Date posted 05/03/2021 Location Cambridge, Massachusetts

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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 Sr. Medical Director Clinical Science Rare Genetics and Hematology (RGH) Therapeutic Area Unit (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

•    The 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 is-sues 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 with matrix re-porting 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. Success or failure directly translates to the ability of Global R&D to meet its corporate goals and for Takeda to have future commercial products.


•    Clinical Development team participation and leadership 
o    Leads Global (US/EU/Japan) Development Team managing both the US/EU Development Team and the Japan Development Team for a given product. May lead the US/EU Development Teams and represent Clinical Science on the Global (US/EU/Japan) Development Team to ensure that activities are aligned with the global strategy.  
o    Establishes and drives Development Team strategy and deliverables producing the Development Strategy, 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. 
o    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 
o    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.
o    Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients. 
•    Trial Medical Monitoring 
o    Responsible for medical monitoring activities, assessing issues related to protocol conduct and individual subject safety.  Assesses overall safety information for studies and com-pound in conjunction with Pharmacovigilance.  Oversees non-medical clinical scientists with respect to assessment of these issues. 
o    Makes final decisions regarding study conduct related to scientific integrity.
•    External Interactions 
o    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 pro-grams 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 
o    Responsible for 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.  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. 
o    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 
o    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.
o    Hires, manages, mentors, motivates, empowers, develops and retains staff to support as-signed activities. Conducts performance reviews and drives goal setting and development planning. 

•    The Senior Medical Director typically manages clinical studies for several assets, including pro-gram level leadership. The Senior Medical Director works autonomously, is excellent at managing cross-functional performance, is frequently involved in evaluation of Business Development opportunities and works well with external partners. He/she is expected to drive department optimization initiatives.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:  (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job.  Any minimum requirements should be noted.)

•    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).
•    Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions. 
•    NDA/MAA/Submission experience preferred.
•    Management experience. 

•    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

•    Therapeutic area knowledge relevant to mechanism of action
•    Regional/global regulatory requirements
•    GCP/ICH
•    Emerging research in designated therapeutic area

•    Ability to drive to or fly to various meetings or client sites, including overnight trips. Some inter-national travel may be required.
•    Requires approximately 15 - 25% travel.

•    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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USA - MA - Cambridge - Binney St

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Job ID R0036247
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