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 Senior Medical Director, Global Pharmacovigilance - Marketed Products in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission: As a Sr MedicalDirector working on the GPSE team, you will be empowered to implement safety-related activities for our robust portfolio of global/regional products, and a typical day will include:
Responsible for the leadership and oversight of a therapeutic area and management of physicians who serve as the Global Safety Leaders (GSL) for both developmental and marketed compounds in designated therapeutic area. The Senior Medical Director will also act as the GSL for one or more products. The Senior Medical Director will interact with and influence other TDC departments (Clinical Operations, Regulatory affairs, Analytical Science, Clinical Science, etc.) to ensure the successful development, design and implementation of comprehensive safety assessment protocols for both developmental and marketed products. The SMD will oversee signal detection and risk management activities in the assigned therapeutic area and ensure that development plans include comprehensive safety assessment plans. The Senior Medical Director will be a key player in the preparation and presentation of materials to the Safety Board and similar forums.
- In conjunction with VP Global Medical Safety/Executive Medical Director, will lead and direct the interpretation of safety data from internal and external studies. To communicates at senior leadership level the impact of such data in terms of go/no go decisions or modification of development plans and/or study designs and the associated impact on timelines and/or labeling
- Responsible for reviewing, analyzing and interpreting information from ongoing clinical and non-clinical studies alongside the assessment of ensuing scientific and medical implications and making recommendations based on new safety information for both developmental compounds and marketed drugs to ensure the primacy of patient safety.
- Participates with colleagues in other Global Safety Functions in the development of a global consensus on signal detection tools and activities
- Viewed as the SME in PV Medical Safety for the assigned therapeutic area, mentors other PV physicians with respect to compounds in development and market drugs, safety monitoring and risk management assessment and analysis.
- Supports cross functional (within and outside Global PV) team evaluations in preparation for Takeda Safety Board presentations as well as having the leadership role for assigned products in safety data presentations to Safety-Board.
- Attends corporate committees such as the Therapeutic Area Teams and Development Review Committee representing the assigned therapeutic area(s).
- Oversees the medical safety evaluation of projects by the PV physicians for new business development opportunities (e.g., due diligence evaluations).
- Directs PV interactions with Regulatory authorities
- Anticipate regulatory implications of emerging safety issues and develop strategies for handling/managing such issues
- In conjunction with Global Risk Management and Pharmacoepidemiology oversee risk management plans for compounds in development and market drugs
- Ensures that PV physicians are proactively identifying safety concerns and developing contingency strategies that address these challenges
- Manages PV physicians in the preparation, analysis and presentation of safety information
- 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 of 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.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
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