Medical Director/Associate Medical Director, Neuroscience Therapeutic Area Unit

Takeda Pharmaceutical Company Ltd Cambridge , MA 02138

Posted 2 months ago

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that I agree with Takeda's Privacy Notice, Privacy Policy and Terms of Use.

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/Associate Medical Director in our NS Therapeutic Area Unit 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 Associate 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 and influences TGRD and TPC senior leadership decision-making by setting strategic direction. Success or failure directly translates to the ability of TGRD 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.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, Clinical Protocols and other documents needed for study execution.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.

  • 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 Takeda's 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.

  • Mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning.


  • MD or internationally recognized equivalent plus 3 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 matrix teams preferred.


  • 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


  • Neurology therapeutic area knowledge desired

  • Regional/global Regulatory requirements


  • Emerging research in epilepsy


  • Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.

  • Requires approximately -10 - 20% 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

Empowering Our People to Shine

Discover more at

No Phone Calls or Recruiters Please.


Cambridge, MA

Worker Type


Worker Sub-Type


Time Type

Full time

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Medical Director / Senior Medical Director

Jounce Therapeutics

Posted 5 days ago

VIEW JOBS 11/26/2020 12:00:00 AM 2021-02-24T00:00 Role / Responsibilities The Medical Director will execute parts of the clinical development strategy for one of Jounce's Immuno Oncology programs, JTX-8064, an anti-Leukocyte Immunoglobulin Like Receptor B2 (LILRB2) antibody and is the first tumor-associated macrophage candidate to emerge from Jounce's Translational Science Platform. He or she will be responsible for the several clinical activities related to the program. Responsibilities: * Design innovative and feasible clinical trials in collaboration with biology, translational research, and clinical team members. * Author clinical trial documents including but not limited to protocols, charters, safety monitoring plans, IND reports, process documents, meeting presentations, publications, and clinical sections of regulatory documents such as INDs, briefing books, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals. * Partner with Data Management for case report form (CRF) design, instructions for unique CRFs, and Data Quality Plan. * Interact frequently with investigators to share new scientific and clinical data and maintain enthusiasm and engagement to optimize clinical trial enrollment * Participate actively as the clinical development expert in study implementation, study oversight and study medical monitoring. * Conduct regular review, analysis, and interpretation of study results. * Participate in tracking/analysis of any potential safety events across trials for JTX-8064. * Serve as primary point of contact for clinical study inquiries from site staff, CROs and site monitors regarding the study protocol, modifications to informed consent, and scientific or medically related questions. * Present at internal and external meetings (e.g., portfolio reviews, clinical advisory boards, investigator meetings, pre-study site selection visits and site initiation visits, Study Coordinator and CRA training, and internal and external medical/scientific meetings). * Maintain awareness and keep program team informed of internal and external developments that may impact the investigational agent Clinical Development Plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review. * Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy. * Participate in development of the long-range strategic plans for the assigned program(s). * Participate as the clinical representative in clinical sub-team meetings Qualifications * The candidate should have a Medical Degree. Board certified in internal medicine (or pediatrics) and medical oncology or hematology (or pediatric oncology) would be preferable. * Candidate should have at least 2 or more years of industry/related experience in cancer related research, drug development and clinical development, preferably in immuno-oncology. * Good knowledge of clinical research and experience across Phase I - III drug development projects. * Experience working effectively on cross-functional teams (matrix organization). * Familiarity with clinical trial design and experience authoring clinical trial protocols (Phase I or II) * Experience in the analysis and interpretation of clinical data and assessment of clinical relevance * Comprehensive understanding of safety profiles and risks * Well-versed in medical aspects of GCP, ICH, FDA, EMEA, and other relevant guidelines * Ability to work independently and to organize priorities and deliverables * Good knowledge and experience with Good Clinical Practice * Strong verbal and written skills Preferred Skills: * Experience designing, conducting, serving as medical monitor, and analyzing data in Phase 1-2 clinical trials in oncology. * Strong Scientific/ Translational experience and expertise with biomarker strategies. * Experience interacting with Contract Research Organizations. * Prior experience writing and submitting INDs to FDA; experience with pre-IND and EOP1 meetings preferred. * Ability to work in a high paced team environment, meet deadlines, & prioritize work on multiple projects * History of strong relationships with academic investigators * Demonstrated functioning well in a diverse organization and cross functional such as with PK, stats, clin ops, medical affairs and other teams involved in clinical development oversight Statement Jounce Therapeutics is an equal opportunity employer and does not discriminate in its employment decisions on the basis of race, color, national origin, age, physical or mental disability, marital status, religion, creed, sex, or political beliefs. We offer a competitive salary and benefits package. All applicants should be legally entitled to work for any employer in the U.S. To apply, please visit Company Summary Jounce Therapeutics, Inc. is a clinical-stage immunotherapy company dedicated to transforming the treatment of cancer by developing therapies that enable the immune system to attack tumors and provide long lasting benefits to patients through a biomarker-driven approach. Through the use of its Translational Science Platform, Jounce first focuses on specific cell types within the human tumor microenvironment to prioritize targets, and then identifies related biomarkers designed to match the right immunotherapy to the right patient. Jounce currently has four development-stage programs, two of which are clinical-stage: vopratelimab, a monoclonal antibody that binds to and activates ICOS, and JTX-4014, a PD-1 inhibitor intended for combination use with Jounce's broader pipeline. Vopratelimab is currently being assessed in a Phase 2 clinical trial, EMERGE, and Jounce plans to initiate an additional Phase 2 biomarker trial using TISvopra for patient selection, SELECT, to assess vopratelimab in combination with JTX-4014. Jounce's IND-enabling preclinical programs include JTX-8064, a LILRB2 receptor antagonist and JTX-1811, a monoclonal antibody designed to selectively deplete T regulatory cells in the tumor microenvironment. For more information, please visit Jounce Therapeutics Cambridge MA

Medical Director/Associate Medical Director, Neuroscience Therapeutic Area Unit

Takeda Pharmaceutical Company Ltd