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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 IB.

• Ensures that the study timeline risks with Takeda post-marketing safety study projects/products are identified promptly, and robust mitigation plans are put in place.

• Represent CPASS on internal and external Post-marketing Study forums as safety and Post -marketing Study experts, including regulatory agency meetings such as EMA, FDA as needed.

• Responsible for on-going process enhancement for post-marketing studies and safety surveillance in general such as developing standard procedures and templates.

• Participate in other activities, teams and committees as assigned.

Strategic guidance and ownership of the Post-marketing Safety Studies development and management is essential for the success of this role to support Takeda Marketed Products Development, and the project teams. Supervisory capabilities are needed to manage a team of Post-marketing Safety Study Leads.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• MD, PhD or Pharm D with specialty training in functional area at least 10 plus years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance with both investigational and marketed products.

• At least 7 years of experience writing and preparing Postmarketing Study documents, including Postmarketing Study Plans, Pharmacovigilance Plans and Risk Minimization Plans or REMS for submission to regulatory agencies.

• Direct experience in the pharmaceutical industry or related field required.

• Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders is a plus.

• Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables.

• Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions.

• Health care business acumen with a comprehensive understanding of the pharmaceutical industry.

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:

USA - MA - Cambridge - Kendall Square - 500

U.S. Base Salary Range:

$205,100.00 - $322,300.00

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 employees may be eligible for short-term and/ or long-term incentives. 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

USA - MA - Cambridge - Kendall Square - 500

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time