Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Medical Director, Global Patient Safety Evaluation (oncology) in our Cambridge, MA office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Medical Director working on the Pharmacovigilance team, you will be empowered to Innovate and Strategize. A typical day will include:
- Support developmental programs, including both early and late stage development as required.
- Responsible for the oversight of signal detection and risk management activities for designated global/regional product(s), together with global safety lead responsibly as appropriate.
- Supporting Therapeutic Lead.
- Line management responsibilities for junior physicians and/or scientists.
- Flexible to support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needs.
- Expectation of Global Safety Lead role for compound(s) both in development and marketed in close association with the Therapeutic Area Lead.
- Company wide safety expert for his/her compound responsibilities.
- Intimate knowledge of safety, including any emerging safety concerns and risk/benefit profile for own compounds with input for other compounds as needed.
- Serving in a leadership capacity for complex and strategically important programs.
- Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs etc.
- Training and mentoring of Pharmacovigilance Physicians and Specialists.
- Perform activities required to serve as Global PV physician:
- Review and oversight of safety data, both non-clinical and clinical
- Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities
- Interactions with external experts and regulatory agencies and partner/co-development companies
- Review of safety data and participate in dose escalation decisions
- Authorship and sign off of Safety Monitoring Plan/Risk Management Plan
- Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
- Direct the set up of safety procedures and development of safety exchange agreements for co-development projects
- Maintain professional knowledge and accreditation by active participation in continuing medical education activities.
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:
- Qualified physician (License, e.g. GMC registered, preferred)
- Knowledge of principles of epidemiology and statistics.
- Critical thinking and analytical skills and ability to make high level decisions
- Excellent oral and written communication skills including ability to present to large internal/external groups
- Good level of computer literacy with Microsoft applications
Minimum of 8 years experience in pharmacovigilance, clinical research or clinical development
2-3 years clinical experience with patients following post-graduate training with significant knowledge of general medicine
- Estimated 5-10 times per year including international travel
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- 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
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.