Talent.com
Executive Medical Director, Oncology Clinical Sciences
Executive Medical Director, Oncology Clinical SciencesTakeda Pharmaceutical • BOSTON, MA, United States
Executive Medical Director, Oncology Clinical Sciences

Executive Medical Director, Oncology Clinical Sciences

Takeda Pharmaceutical • BOSTON, MA, United States
22 days ago
Job type
  • Full-time
Job description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

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 Executive Medical Director, Oncology Clinical Sciences in our Cambridge 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.

OBJECTIVES :

Responsible for ensuring ongoing review and agreement of the Therapy Area Strategy and associated documents formulated by the OTAU leader prior to their review and approval by appropriate governance committees.  Oversees the development and execution of the Integrated Disease Area Strategy (IDAS) and overall Integrated Global Development Plan (IGDP).  Responsible for review of synopses, other relevant clinical study documents and Critical Study Results.  Provide leadership and oversight of respective clinical development activity. Responsible for providing guidance to TA leaders on regional specificities within Therapeutic Area.

ACCOUNTABILITIES :

  • Accountable to Oncology Clinical Science Head to provide strategic clinical input on assigned clinical studies.

Leads the Global Development Team (US, EU, and others) managing both the US / EU Development Team and the Japan / China Development team for assigned compounds. In some cases may lead the US / EU Development Team but more likely will oversee the study physician and / or clinical scientist leads responsible for leading the team. Emphasis will be on insuring that the development teams are proactively identifying contingencies, potential risks and strategies to address future obstacles.

  • Directs Development Team strategy and deliverables overseeing the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, which influence the budget of 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.
  • Responsible for high impact global decisions : 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. Plans clinical development strategies in context of medical / clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medical need.
  • Accountable for ensuring regional strategies and trade-offs in regional requirements are well articulated in the global strategy documentation and that stakeholders are appropriately briefed.
  • Providing strategic input into global development strategies and plans for all compounds in OTAU.
  • Providing clinical and strategic support to evaluation of external compounds (alliances and in-licensing opportunities)
  • Primary interface with Medical Affairs team for strategy and to support of product commercial efforts
  • Contributing to the creation and maintenance of regional KOL network
  • Providing recommendations for GDT leader nominations and reviewers of external compounds as part of business development efforts
  • Liaison with Clinical Operations and Project Management for co-ordination of logistics study planning and implementation
  • Consistent with membership of the Clinical Review Board Committee, responsible for critical review of Synopses, protocols, IBs and relevant clinical documents relating to studies in assigned compounds.
  • Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds.
  • Oversees and leads all clinical science activities involved in interactions with FDA, other regulatory agencies and key opinion leaders relevant to assigned compounds.
  • Responsible for evaluation of external interactions in the context of overall development strategies using complex problem solving in the region but in context of a global environment.
  • Proactive identification of challenges and development of contingency plans as appropriate.
  • Responsible for evaluation of potential business development opportunities in the region but with the context of a global environment.
  • Conducts due diligence evaluations, of clinical development plans for potential alliances and or in-licensing opportunities.
  • 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.
  • Assigns and manages clinical science staff who are involved in many of these activities.
  • Interacts directly with research division based on pertinent clinical and development expertise and in all aspects relating to assigned compound in regional area.  Leads TGRD internal teams and global cross-functional teams. Works with functional leadership to prioritize projects within the therapeutic area.
  • Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning.
  • EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS :

    Experience

  • MD or combined MD / PhD  or internationally recognized equivalent with minimum 10 years pharmaceutical research experience, including minimum 7 years phases I-IV clinical development experience.
  • Training and Experience in Hematology and / or Medical Oncology especially hematologic malignancies is highly preferred
  • Previous experience in successfully leading a clinical development team / matrix team with responsibility for studies in multiple regions. Development experience beyond US / EU a plus.
  • NDA / MAA / Submission experience strongly preferred
  • Experience with and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals 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 across multinational business cultures
  • TRAVEL REQUIREMENTS :

  • Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
  • Requires approximately 25 % travel.
  • 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, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law

    This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

    #LI-JT1

    Takeda Compensation and Benefits Summary

    We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

    For Location : Boston, MA

    U.S. Base Salary Range :

    The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained , certifications or other professional licenses held, and the location in which the applicant lives and / or from which they will be performing the job.   The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

    U.S. based e mployee s may be eligible for s hort - t erm and / or l ong- t erm incentive s . U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

    EEO Statement

    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, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

    Locations

    Boston, MA

    Worker Type

    Employee

    Worker Sub-Type

    Regular

    Time Type

    Full time

    Job Exempt

    Yes

    It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

    Create a job alert for this search

    Medical Director • BOSTON, MA, United States

    Related jobs
    Associate Medical Director / Medical Director, Clinical Development(Neuroscience / Psychiatry)

    Associate Medical Director / Medical Director, Clinical Development(Neuroscience / Psychiatry)

    AbbVie • Cambridge, MA, US
    Full-time
    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkab...Show more
    Last updated: 30+ days ago • Promoted
    Medical Director

    Medical Director

    AVEO Oncology • Boston, MA, US
    Full-time
    Senior Vice President, Head of Clinical Development.AVEO Oncology is seeking a highly skilled and experienced Medical Director to join our dynamic team. The successful candidate will have a strong b...Show more
    Last updated: 30+ days ago • Promoted
    Senior Medical Director

    Senior Medical Director

    C4 Therapeutics Inc • Watertown, MA, US
    Full-time
    C4 Therapeutics (C4T) (Nasdaq : CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medic...Show more
    Last updated: 29 days ago • Promoted
    Medical Director

    Medical Director

    Theoria Medical • Middleboro, MA, US
    Full-time
    Leading the charge in healthcare innovation, Theoria Medical offers a unique blend of medical excellence and technological advancement, primarily serving the post-acute and primary care sectors.Our...Show more
    Last updated: 30+ days ago • Promoted
    Sr. Director, Clinical Science

    Sr. Director, Clinical Science

    Apellis • Waltham, MA, US
    Full-time
    Director, Clinical Science, is a key member of our clinical development team, contributing to and providing leadership on the development and execution of the clinical strategy for current and futu...Show more
    Last updated: 1 day ago • Promoted
    Director, DMPK

    Director, DMPK

    Deciphera Pharmaceuticals • Waltham, MA, US
    Full-time
    We are seeking an accomplished and strategic.Head of Clinical Pharmacology, DMPK, and Bioanalysis (CP / DMPK / BA).DMPK scientists and serve as a key subject matter expert. The Director will partner cro...Show more
    Last updated: 12 days ago • Promoted
    Medical Director

    Medical Director

    Brooksby Village by Erickson Senior Living • Peabody, MA, US
    Full-time
    Brooksby Village by Erickson Senior Living.We are hiring a Medical Director to join our growing physician-lead geriatrics practice. Erickson Senior Living,® a national leader in senior living an...Show more
    Last updated: 22 days ago • Promoted
    Senior Medical Director

    Senior Medical Director

    VirtualVocations • Dorchester, Massachusetts, United States
    Full-time
    A company is looking for a Senior Medical Director, Clinical Development.Key Responsibilities : Supports the development of clinical trial protocols and oversees the conduct of clinical trials Pr...Show more
    Last updated: 30+ days ago • Promoted
    Senior Medical Director

    Senior Medical Director

    Ardelyx • Waltham, MA, United States
    Full-time
    Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medic...Show more
    Last updated: 16 days ago • Promoted
    Executive Medical Director, Immunology

    Executive Medical Director, Immunology

    VirtualVocations • Lowell, Massachusetts, United States
    Full-time
    A company is looking for an Executive Medical Director, Clinical Development.Key Responsibilities : Provide strategic leadership and medical expertise for clinical development of antibody portfoli...Show more
    Last updated: 3 days ago • Promoted
    Sr. Medical Director / VP, Clinical Development

    Sr. Medical Director / VP, Clinical Development

    Kelonia Therapeutics • Boston, MA, US
    Full-time
    Here at Kelonia Therapeutics, we aren’t just a clinical company; we’re trailblazers in viral engineering, pushing the boundaries of in vivo lentiviral gene and cell therapy.We're no...Show more
    Last updated: 15 days ago • Promoted
    Senior Medical Director, Clinical Development

    Senior Medical Director, Clinical Development

    DynamiCure Biotechnology • Waltham, MA, US
    Full-time
    Senior Medical Director, Clinical Development.DynamiCure is seeking a talented, independent, and motivated clinician to help build our clinical development group. You will join a small but growing c...Show more
    Last updated: 30+ days ago • Promoted
    Medical Director

    Medical Director

    VirtualVocations • Lowell, Massachusetts, United States
    Full-time
    A company is looking for a Medical Director to oversee clinical documentation and coding compliance for inpatient charts. Key Responsibilities Provide clinical leadership and maintain collaborativ...Show more
    Last updated: 30+ days ago • Promoted
    Executive Director / Vice President, Medical Lead

    Executive Director / Vice President, Medical Lead

    Crescent Biopharma, Inc. • Boston, MA, US
    Full-time
    Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s pipeline includes its lead program, a PD-1...Show more
    Last updated: 1 day ago • Promoted
    Senior Medical Director, Oncology Clinical Development (Office Based - Cambridge, MA)

    Senior Medical Director, Oncology Clinical Development (Office Based - Cambridge, MA)

    Zai Lab (US) LLC • Cambridge, MA, US
    Full-time
    Zai Lab is a patient-focused, innovative, commercial-stage, global biopharmaceutical company based in China and the United States. We are dedicated to discovering, developing, and commercializing be...Show more
    Last updated: 30+ days ago • Promoted
    Senior Medical Director, Clinical Development

    Senior Medical Director, Clinical Development

    Deciphera Pharmaceuticals • Waltham, MA, US
    Full-time
    We are seeking a dynamic and strategic.Senior Medical Director, Clinical Development.This critical leadership role will provide clinical direction across one or more programs in early and / or late-s...Show more
    Last updated: 30+ days ago • Promoted
    Medical Director, Clinical Research (Early-stage)

    Medical Director, Clinical Research (Early-stage)

    Scholar Rock • Cambridge, MA, US
    Full-time
    Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biolo...Show more
    Last updated: 15 days ago • Promoted
    Medical Director, Clinical Development

    Medical Director, Clinical Development

    Deciphera Pharmaceuticals • Waltham, MA, US
    Full-time
    We are seeking a driven and strategic.Medical Director, Clinical Development.This pivotal role offers the opportunity to shape clinical strategy, serve as medical monitor, and collaborate cross-fun...Show more
    Last updated: 8 days ago • Promoted