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 an Executive Medical Director, Pharmacovigilance in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Executive Medical Director working on the Pharmacovigilance team, you will be empowered to Strategize and Direct Vision. A typical day will include:
Responsible for the leadership and oversight of major and complex therapeutic areas. These include multiple complex development programs that can be grouped in more than one specialty therapeutic areas (such as CV/Metabolic or Internal Medicine, etc.), or a large scale homogenous therapeutic area that consists of multiple complex programs. The Executive Medical Director (EMD) is also responsible for management of physicians who serve as the Global Safety Leaders (GSL) for both developmental and marketed compounds in designated therapeutic area and may act as a GSL. The EMD will also manage Senior Medical Directors who may oversee a single therapeutic area (such as Diabetes, or CV, etc). The EMD 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 EMD will oversee and manage signal detection and risk management activities undertaken by the GSLs and ensure that both developmental and marketed compounds have a comprehensive safety assessment plan in situ. Further, this position will oversee and manage the reactive response to any new safety signal/crisis, although the primary responsibility will reside with the GSL. The position holder will have a pivotal role in managing contributions/presentations to Safety Board and similar forums.
- In conjunction with VP Global Safety and other functions within Global Pharmacovigilance will ensure effective functioning of the department including strategic and long-term planning and resource assessments
- In conjunction with VP Heads Global Safety and relevant PV and extra PV disciplines, including Regional Head of PV will lead and coordinate interpretation of safety data from internal and external studies/sources and communicate at senior leadership level the impact of same both in terms of go/no go decisions or modification of development plan or study design, including potential impact on timeline or product labeling
- Responsible for reviewing, analyzing and interpreting safety information from ongoing clinical and non-clinical studies, alongside the assessment of ensuing scientific and medical implications. Further, coordinating/leading recommendations derived from new safety data for developmental compounds and marketed drugs, ensuring the primacy of patient safety.
- Leads along with colleagues in allied Safety Functions the development of a global consensus on signal detection tools and activities
- As one of the most senior physicians in PV Medical Safety will mentors other PV physicians for developmental compounds and market drugs, safety monitoring and risk management assessment and analysis.
- Responsible for presentations to Safety Board and similar forums and will help facilitate cross functional interactions (within and outside Global PV) for same. As appropriate the position holder will directly involve himself/herself in presentations to Safety Board, recognizing that this will primarily reside with the GSL.
- Will ensure that he/she ensures follow up to request from 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.
- Substantial experience in pharmacovigilance, clinical research or clinical development, including significant experience in operating 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.
- Must have demonstrable experience in people management at a leadership level and well-developed skills in teambuilding, motivating, empowering and developing people.
- Demonstrate integrity
- 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
- 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.
Kate Lohrey #LI-KL1