Senior Medical Director, Global Patient Safety - GI - United States
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 - Gastroenterology in ourCambridgeoffice.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission:
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, BEHAVIORAL COMPETENCIES AND SKILLS:
- Medical degree required or internationally recognized equivalent.
- Minimum of 8 years experience in pharmacovigilance, clinical research or clinical development, including a minimum of 3 years in a global pharmacovigilance organization. Experience in preparing responses to regulatory agencies on safety-related topics and aggregate analysis of safety data is required.
- Direct clinical experience with patients following post-graduate training with appropriate grounding and knowledge of general medicine.
- Minimum 3 years people management experience and/or proven leadership experience in managing a global, matrix team.
- Excellent communication skills
- Demonstrate integrity
- Relate well to people at all levels
- Motivate and empower others
- Work productively in a high pressure environment
- Good analytical/judgment capabilities to understand/analyze/synthesize and communicate
- Project Management abilities
- Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and understand proactively the interactions necessary for achieving business goals and objectives
- Able to manage both time and priority constraints and to manage multiple priorities simultaneously
- Attention to details, computer literacy, knowledge of safety database
- Take initiative and autonomous action
- Able to lead teleconferences and meetings
- Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / caching skills
- Some travel within Takeda global sites may be required.
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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