Sr. Director, Head of Center for Post Approval Safety Studies (CPASS)

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Job Description

The Head of The Center for Post Approval Safety Studies (CPASS) will have oversight of all regulatory required post-marketing safety studies, including EU Post-authorization safety studies (PASS), Regional Post-marketing surveillance studies, and other Post-marketing safety commitments/requirements.  Maintains current knowledge and strategic oversight of assigned product portfolio and corresponding regulatory commitments which includes safety study commitments for products across multiple therapeutic areas. He/she is responsible for leading a team of Post-marketing safety Study Leads, a PMS Compliance Lead, understanding the regulatory requirements related to product approvals, worldwide product license renewals and submission/renewal strategies for assigned assets in development and marketed products. He/she is responsible for the development and internal approval of study protocols, monitoring of the study milestones and preparation of study related periodic and final reports for submission to worldwide regulatory agencies, with support from the Takeda study team and designated vendors when available.

• Responsible for the overall strategy and implementation of post-marketing safety studies and related commitments for Takeda products.

• Provide guidance to study teams to improve the quality, consistency and output of protocols, related negotiations, responses and finalization with regulatory agencies.

• Leads discussions in Protocol Review Committees, Safety Review Teams and other safety committees as needed.

• Direct management of team of Post-Marketing Safety Study Leads for various therapeutic areas and/or products. Supervision and support include but not limited to:

• Assignment of products and representation of Post-marketing safety study support within Takeda.

• Supporting the individual Post-marketing Safety Study Lead and assigned Post-marketing Safety team and multiple project deliverables.

• Supporting the Post-marketing Safety Study Lead in prioritization and provide expert advice for efficient planning to ensure  quality outputs.

•  Reviewing work outputs, documents, etc. produced by the Lead and providing critical review and expert thinking before agreeing for further review by other line functions.

• Providing back up support for the Post-marketing Safety Study Lead and projects as needed.

• Hiring, training, mentoring, development and performance management of Post-marketing Study Leads.

• Ensuring performance and alignment of personal and team goals to Global Medical/Marketed Products Development goals and objectives.

• Ensuring performance and alignment of personal and team goals to Global Medical/Marketed Products Development goals and objectives

• Represent the CPASS team on cross functional teams and Interface with other Takeda functional groups such as Regulatory Affairs, Patient Safety and Pharmacovigilance, Global Development Operations, Medical Affairs, Quality, and business units, as needed.

• Liaise effectively with Takeda LOCs (Local Operating Companies) in the understanding of local and country regulations which impact post-marketing commitments including, development and implementation of post-marketing safety studies.

• Communicates effectively on product safety/risks to senior management and the Office of the EU Qualified Person.

• Critically review & provide input to  MAA Submission & ad hoc submission responses, product license renewals, PBRER, RMPs, Regulatory responses, and