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Job Description

About the role:

Join Takeda as a Medical Director, PV, Oncology where you will support developmental programs, including both early and late-stage development. You will also manage the oversight of signal detection and risk management activities for designated global/regional product(s), together with the global safety lead responsibly. You will also be responsible for line management responsibilities for junior physicians and/or scientists and support compounds/initiatives outside of the primary therapeutic area(s) as directed by business and departmental needs. As part of the Global Patient Safety and Evaluations team, you will report to Senior Medical Director, Pharmacovigilance - Oncology, and work with the global medical safety teams.

How you will contribute:

• Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing, and scientific literature.
• Conduct signal detection, monitoring, evaluation, interpretation, and management for assigned compounds and products.
• Develop a strategy for and lead the preparation of responses to safety-related inquiries from regulatory agencies and ethics committees.
• Ensure communication of all safety information that may impact the benefit-risk profile of assigned products to senior management.
• Provide medical safety expertise, medical interpretation, review, and authorship of appropriate sections for critical documents (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, Health Hazard Evaluations, Signal Evaluation Reports, INDs, NDAs, BLAs, and CTAs) in collaboration with cross-functional colleagues.
• Provide patient safety input to the clinical development program for assigned products and development compounds, and represent GPSE on internal governance bodies for study protocols, statistical analysis plans, and other clinical study-related documents as applicable.
• Manage benefit-risk profile, including authoring and updating of the benefit-risk documents, e.g., RMPs, for assigned compounds and products.
• Collaborate and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
• Interact with Regulatory Authorities as part of a cross-functional team to submit and defend regulatory inquiries, MAAs, NDAs, and BLAs.
• Ensure up-to-date representation of safety information in the Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure, as well as other labeling documents.
• Demonstrate knowledge of local and global health authority requirements.
• Support GPSE in the maintenance of a highly effective global safety organization in full compliance with worldwide regulations.
• Train and mentor Pharmacovigilance Physicians and Specialists.
• Maintain professional knowledge and accreditation by active participation in continuing medical education activities, and fosters a community of continual learning.

Minimum Requirements/Qualifications:

• M.D. or D.O. or internationally recognized equivalent, with direct clinical experience in patient care following post-graduate training and appropriate grounding and knowledge of general medicine.
• Board certification and licensure are preferred.
• At least 5 years of experience in the pharmaceutical industry within Drug Safety/Pharmacovigilance, with both investigational and marketed products.
• At least 3 years of experience with aggregate reporting, safety surveillance, signal management, and/or risk management.
• Knowledge and understanding of national and international PV and regulatory guidelines.

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 a 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 "remote" in accordance with Takeda's Hybrid and Remote Work policy.

Base Salary Range: $ 217,000 to $ 310,000, based on the candidate's 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.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

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.

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