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, Neuroscience in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Medical Director working on the Global Medical Safety team, you will be empowered to xxxx and xxxx, 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 cross functionally within designated therapeutic area (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.
Specific to this role, key competencies/experience include:
- Significant Neuroscience experience in a clinical development or medical safety lead role. Therapeutic experience in this field would be advantageous but not mandatory
- Experience with biologics and / or novel therapeutics (e.g. cell and gene therapy)
- Experience managing direct reports in a matrix organization
- 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
- Integral to the Global Product Team for his/her compound responsibilities
- Attends corporate committees such as the Therapeutic Area Teams and Development Review Committee representing the assigned therapeutic area(s).
- Directly responsible/ oversees the medical safety evaluation of projects 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 Risk Management and Pharmacoepidemiology oversee risk management plans for developmental and marketed drugs
- Proactively identifies safety concerns and associated contingency strategies and/or oversee physician colleagues re same
- 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
- Line management and/or function responsibilities commensurate with a skilled and experienced physician
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
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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