Executive Medical Director, Pharmacovigilance, Gastrointestinal and Inflammation (Hybrid)

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Job Description

About the role:

Join Takeda as an Executive Medical Director, Pharmacovigilance in Gastrointestinal and Inflammation (GI²). You will oversee medical safety activities and processes for assigned products, ensuring continuous assessment of safety profiles and benefit-risk of investigational compounds.

You will provide strategic, patient-focused leadership for medical safety, support asset strategies, and strengthen medical and scientific innovation. Timely escalation of safety issues to the Takeda Safety Board Chair is required. You will define and implement a vision for Patient Safety, enhance medical safety capabilities, and be a core member of company-wide Committees and Governance.

As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will report to the Vice President, Therapeutic Area Head of Gastrointestinal and Inflammation PSPV. You will manage/oversee physicians and Health Care Professionals (HCPs) serving as Global Safety Leaders (GSL) and PV Scientists for clinical developmental and marketed compounds in the designated therapeutic area.

How you will contribute:

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

• Oversight of cross-functional Safety Management Teams for allocated TA.

• Responsible for the 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 the designated therapeutic area and may act as a GSL.

• 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.

• 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.

• Develops medical safety operational process frameworks.

• Drives process improvement and change management in concurrence with company-wide and functional plans.   

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

• Ensures, in conjunction with the Head, GI2 PSPV Therapeutic Area and other functions within PSPV, the effective functioning of the department including strategic and long-term planning and resource assessments.

• Deputizes for the VP, Head, of Global Medical Safety, Gastrointestinal and Inflammation Therapeutic Area Unit.

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

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

• In conjunction with other TAHs, Medical Safety, and other relevant PSPV/cross-functional disciplines leads and coordinate 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 the 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. Further, coordinates/leads recommendations derived from emerging new safety data for developmental compounds and marketed drugs, ensuring the primacy of Patient safety.

• Leads and/or participates along with PSPV and cross-functional colleagues in the development of a global consensus on signal and risk management tools and activities.

• As one of the most senior physicians in PSPV 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 PSPV 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 PSPV 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 the 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 develops strategies for handling/managing such issues, Directs PSPV interactions with Regulatory Authorities.

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

• Assists in optimizing PSPV capacity and capability planning and execution.

• Leads and/or contributes to initiatives across disciplines and cross-functionally.

• Contributes to creating and communicating an environment 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. 

• Maintains knowledge of products and product environment.

• 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.

Minimum Requirements/Qualifications:

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

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

• Minimum of 5 years of 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.

• Safety submission experience is desirable.

• Experience 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 the 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 team building, 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 in prioritization of multiple issues.

• Computer literate, including safety database acumen.

• Self-resourced, with the confidence to take the initiative and act autonomously.

• Both facilitate and efficiently lead meetings, both in person and in other media.

• Excellent communication skillset, orally and presentational.

• Proven ability to work globally and cross-functionally, with strong interpersonal skills /appropriately assertive /team-minded and mentoring.

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.

Discover more at takedajobs.com

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