Vice President of Clinical Science, Marketed Products

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Vice President of Clinical Science, Marketed Products in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Vice President of Clinical Science, Marketed Products working on the Marketed Products team, you will be empowered strategic oversight for marketed products in all therapeutic areas not led by TAUs and a typical day will include:

Responsible for Global Clinical and Medical strategic oversight for marketed products in all therapeutic areas not led by TAUs. Due to the nature of Marketed Products, this position will be responsible for both medical oversight (e.g., CMO functions) and Clinical Development (e.g., Clinical Science Head functions) for a large number of products spread globally with the majority in areas of the Emerging Markets. Leads the Marketed Products physician teams in providing Medical oversight and providing cross functional input to Global Development Teams (GPTs) and Established Products Team (EPT), working with Project Management, Pharmacovigilance, Regulatory Affairs, and Clinical Operations. Oversees benefit risk assessments, clinical regulatory submissions and clinical development plans, ensuring continued accessibility of Takeda’s on-market medicines to patients where they are approved. Plans reflect regional input and execution but are designed globally. This position plays an influential stakeholder role with the GPTs led by the Global Product Leaders and the EPT.

ACCOUNTABILITIES:

• Responsible for Global Clinical and Medical strategic oversight for marketed products in all therapeutic areas not led by TAUs.
• Leads the Marketed Products physician teams in providing Medical oversight and providing cross functional input to GPTs and EPT, working with Project Management, Pharmacovigilance, Regulatory Affairs, Clinical Operations and commercial stakeholders.
• Oversees benefit risk assessments, clinical regulatory submissions and clinical development plans, ensuring continued accessibility of Takeda’s on-market medicines to patients where they are approved. Plans reflect regional input and execution but are designed globally.
• Leads the Clinical Science function role in the Global EPT
• Has an influential stakeholder role with the GPTs led by the Global Product Leaders and the EPT.
• Working closely with the Pharmacovigilance and Quality functions to ensure safety and quality matters are appropriately addressed and resolved in a timely manner through appropriate benefit/risk assessments.

• Collaborate and provide influence to Medical Affairs activities for LCM, country level strategies and provides input to Medical Affairs Phase IIIb / IV studies and local protocols.
• Accountable to Head of Marketed Products for delivery of geographic expansion clinical development strategy which include key aspects of Target Product Profiles (TPPs) required for successful development, continued commercialization and pricing and reimbursement.
• Ensures that the Marketed Products Clinical Science physicians work closely with the GPTs and Established Products Sub Teams (EPST) in all activities including medical oversight, risk/benefit assessments, regulatory submissions, clinical development, safety and quality issues, etc.
• Lead Clinical Science evaluations for post-marketing licensing candidates through nomination and oversight of staff for technical DD and coordination for development input and recommendations.
• Ensures ongoing collaboration with all regions, and that the Marketed Products clinical team members are proactively seeking input from the regions.

• Lead and harmonize the Clinical Science organization in terms of process management, resource allocation, efficiency and standards, ensuring equitable regional utilization of resources

• Hiring, retaining and developing talented physicians who will be accountable for medical oversight or participation in the designs of clinical drug development plans and for the execution of such plans for their therapeutic area and global prioritization and tradeoffs.
• Ensure rapid and effective resolution of strategic or scientific issues for marketed products to meet company milestones.
• Working with clinical operations and global product teams, ensure excellent execution of integrated drug development programs across multiple therapeutic areas, including ensuring appropriate budget and schedule planning are obtained to meet project needs.
• Develop and maintain sufficient working familiarity with the scientific and medical aspects for oversight of all therapeutic areas in order to provide scientific and strategic guidance, mentoring and leadership across these areas.

• Ensure in liaison with Quantitative Science groups as well as clinical modeling teams as to the strategy and the integrity and correctness of analysis, interpretation and appropriate integration of safety and efficacy data from development programs and clinical studies longitudinally and cross-sectionally in support of regulatory submissions across all therapeutic areas, ensuring data quality and adherence to national and international regulations and requirements and ICH.

• Provide ad hoc input and collaboration with (internal and external) and cross-functional strategic teams and task forces.
• Represent Clinical Science at the global team level, providing overall clinical development /local regulatory submission experience and leadership where required.
• Develop and maintain strong relationships with key opinion leaders in certain therapy areas and promote the company’s reputation.

• Represent the Marketed Products in Sr. Level Scientific governance meetings (i.e. Safety Review Board, Global Labeling Oversight Committee (GLOC).

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

• MD or internationally recognized equivalent with substantial clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
• 12+ years clinical research/clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
• Track record and demonstrated ability to lead and manage both science and business aspects of drug development. NDA/MAA/Submission experience required
• Experience with and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals
• Experience in working across more than one region strongly preferred

  
  Skills

• Superior communication, strategic, interpersonal and negotiating skills
• Ability to proactively predict issues and solve problems
• Ability to facilitate win-win solutions and ensure diverse opinions are heard whilst still ensuring decision-making within a multi-disciplinary, multi-regional, matrix teams
• Diplomacy and positive influencing abilities across multinational business cultures

  
  Knowledge

• Emerging research in Clinical Science and Translational Medicine
• Nonclinical and clinical drug discovery and development
• Regional/global Regulatory requirements
• GCP/ICH

TRAVEL REQUIREMENTS:

• Ability to drive to or fly to various meetings or client sites, including overnight trips. International travel will be required.
• Requires approximately 20 – 30% travel.

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

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

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Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0014290