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Takeda Pharmaceuticals Head, Global Medical Safety, Oncology Therapeutic Area Unit, Global Patient Safety & Evaluation in Boston, Massachusetts

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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as Head, Global Medical Safety, Oncology Therapeutic Area Unit, Global Patient Safety & Evaluation where you will have oversight of medical safety activities and processes for the allocated Therapeutic Area with ensuring the continuous assessment of the safety profile and of the benefit risk of investigational compounds and marketed product. You will provide strategic and Patient focused leadership and vision for further development of medical safety TA in support of asset strategy. You will strengthen Patient focused medical and scientific excellence/innovation. You will also timely escalates safety issues to Chair, Takeda Safety Board as required.

As part of the Global Patient Safety & Evaluation (GPSE) team, you will report to Senior Vice President, GPSE.

How you will contribute:

  • Core member of the GPSE Leadership Team; Member of the extended R&D leadership Team for allocated Therapeutic Area

  • Maintains and develops innovative medical safety. Develops and implements Patient focused functional vision

  • Oversight of cross functional Safety Management Teams for allocated TA

  • Responsible for management of physicians and Health Care Professionals (HCPs) who serve as the Global Safety Leaders (GSL) and PV Scientists for both developmental and marketed compounds in designated therapeutic area and may act as a GSL.

  • The position holder has a pivotal role in managing adequate interactions with Takeda Safety Board and company wide Committees and Boards for the allocated portfolio of products

  • Interacts with and influences other cross functional departments (e.g. Development Operations, Regulatory Affairs, Medical Affairs, Data Science Institute, Clinical Science, etc.) to ensure the successful development, design and implementation of comprehensive safety and benefit risk assessment for both developmental and marketed products for allocated TA

  • Influential and external presence in area of medical safety expertise for allocated TA

  • Drives process improvement and change management in concurrence with company wide, KPIs and functional plans

  • Drives and advances TA medical safety capability and capacity both strategically and with innovative approaches

  • Ensures, in conjunction with Head, GPSE and other functions within GPSE, effective functioning of the department including strategic and long-term planning and resource assessments

  • Contributes in the development and implementation of innovative and Patient focused strategies to support medical and scientific safety excellence

  • Maintains and develops perspectives to enhance GPSE innovation from external expertise and network

  • In conjunction with other TAHs, Medical Safety and other relevant GPSE/cross functional disciplines leads and coordinates interpretation of safety data from internal and external studies/sources and communicates at senior leadership level the impact of same both in terms of “go/no go” decisions or modification of development plan or study design, including potential impact on developmental and registrations timelines or product labeling

  • Responsible for reviewing, analyzing and interpreting safety information from ongoing clinical and non-clinical studies, alongside the assessment of ensuring scientific and medical implications for allocated portfolio of products. Further, coordinates/leads recommendations derived from emerging new safety data for developmental compounds and marketed drugs, ensuring the primacy of Patient safety.

  • Oversees and manages signal and risk management activities undertaken by the GSLs and PV Scientists and ensures that both developmental and marketed compounds have a comprehensive safety assessment plan in situ.

  • Oversees and manages any emerging safety signal although the primary responsibility will reside with the GSL. The position holder will have a pivotal role in managing contributions/presentations to Takeda Safety Board and company wide Committees and governances

  • Leads and/or participates along with GPSE and cross functional colleagues to the development of a global consensus on signal and risk management tools and activities

  • Develop medical safety operational framework safety as required

  • As one of the most senior physicians in GPSE will mentor other PV physicians and HCPs for adequate safety monitoring and signal/ risk management assessment and analysis for developmental compounds and marketed drugs

  • Responsible for presentations to Safety Board and other company wide Committees and Governance and facilitates cross functional interactions (within and outside GPSE for same. As appropriate the position holder will directly involve himself/herself in presentations to Safety Board, recognizing that this will primarily reside with the GSL and will ensure follow up to requests from Safety Board

  • Attends corporate committees and external Boards representing the assigned therapeutic area(s).

  • Oversees the medical safety evaluation of projects by the GPSE physicians and HCPs for new business development, potential in-licensing opportunities (e.g. due diligence evaluations) and Pharmacovigilance Agreements with Business Partners

  • Supervises the allocated medical safety team in the preparation, analysis and presentation of safety information, compilation of highest quality and medical interpretation of safety data in support of safety update regulatory submissions, investigational and new drug applications and interactions with Regulatory Authorities worldwide

  • Ensures the oversight of safety related activities performed by partners and CROs specifically for quality and performance

  • Anticipates regulatory implications of emerging safety issues and develop strategies for handling/managing such issues, Directs GPSE interactions with Regulatory Authorities

  • Ensures that GPSE physicians and HCPs are proactively identifying safety concerns and developing contingency strategies that address these challenges

  • Assists in optimizing GPSE capacity and capability planning and execution

  • Contributes to creating and communicating an environmental culture and values which attract, inspire, retain and develop the most effective talents at all levels to maximize their career development and contribution to the Business

Minimum Requirements/Qualifications:

  • Medical Degree (MD) required or internationally recognized equivalent ideally combined with Advanced Degree

  • 10 years+ experience gained in Pharmacovigilance, Clinical Research or Clinical Development within Pharmaceutical industry and/or academia and/or CRO including significant experience in operating in a global pharmacovigilance organization and Minimum of 5 years experience in people management

  • Demonstrated knowledge of regulatory agency requirements regarding drug safety and an understanding of general drug safety methodologies.

  • Ability to comprehend and synthesize complex data and should have experience in the identification, analysis and implementation of programs and procedures required to achieve corporate objectives.

  • Experience of operating in a multi-disciplinary drug development environment including international experience and exposure to a variety of therapeutic areas.

  • Experience working in an outsourced environment managing suppliers, CROs, vendors and strategic partnerships.

  • Identifies opportunities and anticipates changes in the medical safety landscape through an understanding and ongoing assessment of the environment affecting Patient.

  • Develops partnerships with internal and external stakeholders strategic objectives.

  • Inspires commitment through a wide range of communication channels (meetings, writing, presentations) and demonstrates integrity

  • Must have demonstrable experience in people management at a leadership level and well-developed skills in teambuilding, motivating, empowering and developing people.

  • Work productively in a fast moving and pressured environment

  • Good analytical/judgment capabilities to understand, analyze/synthesize and communicate successfully and concisely

  • Well-developed time management skillset to assist prioritization of multiple issues; Self-resourced, with confidence to take the initiative and act autonomously

  • Maintains expertise and awareness/understanding of international PV regulatory requirements (FDA, EMA, PMDA) and guidelines (CIOMS, ICH); Ensures compliance with regulatory and medical/scientific standards and guidelines

  • Maintains professional knowledge and accreditation by active participation in continuing medical education activities.

What Takeda can offer you:

  • Comprehensive Healthcare: Medical, Dental, and Vision

  • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

  • 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 and company match of charitable contributions

  • Family Planning Support

  • Flexible Work Paths

  • Tuition reimbursement

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Base Salary Range: $265,000 to $417,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

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

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