Takeda Pharmaceuticals Executive Medical Director, Therapeutic Area Lead in Des Moines, Iowa
About the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as an Executive Medical Director, Therapeutic Lead where you will Maintain and develop innovative medical safety capabilities and provide oversight of cross functional Safety Management Teams for allocated TA. You will also be Responsible for reviewing, analyzing, and interpreting safety information from ongoing clinical and non-clinical studies, alongside the assessment of ensuring scientific and medical implications. Further, coordinates/leads recommendations derived from emerging new safety data for developmental compounds and marketed drugs, ensuring the primacy of patient safety.
How you will contribute:
Ensures, in conjunction with Head of Global Medical Safety, Marketed Product Development, and other functions within GPSE, effective functioning of the department including strategic and long-term planning and resource assessments.
Deputizes for the VP, Head of Global Medical Safety, Marketed Product Development
Ensures the oversight of safety related activities performed by partners and CROs specifically for quality and performance.
Accountable for the scientific integrity of all safety deliverables and adherence to SOPs and regulatory guidance.
Contributes to the development and implementation of innovative and Patient focused strategies to support medical and scientific safety excellence.
Maintains and develops perspectives to enhance GPSE innovation from external expertise and network.
In conjunction with other TAHs, Medical Safety and other relevant GPSE/cross functional disciplines leads and coordinates interpretation of safety data from internal and external studies/sources and communicates 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 developmental and registrations timelines or product labeling.
Responsible for reviewing, analyzing, and interpreting safety information from ongoing clinical and non-clinical studies, alongside the assessment of ensuring scientific and medical implications. Further, coordinates/leads recommendations derived from emerging new safety data for developmental compounds and marketed drugs, ensuring the primacy of patient safety.
Leads and/or participates along with GPSE and cross functional colleagues to the development of a global consensus on signal and risk management tools and activities.
As one of the most senior physicians in GPSE will mentor other PV physicians and HCPs for adequate safety monitoring and signal/ risk management assessment and analysis for developmental compounds and marketed drugs.
Responsible for presentations to Safety Board and other company wide Committees and Governance and facilitates cross functional interactions (within and outside GPSE). As appropriate the position holder will directly involve himself/herself in presentations to Safety Board, recognizing that this will primarily reside with the GSL and will ensure follow up to requests from Safety Board
Attends corporate committees and external Boards representing the assigned therapeutic area(s).
Oversees the medical safety evaluation of projects by the GPSE physicians and HCPs for new business development, potential in-licensing opportunities (e.g., due diligence evaluations) and Pharmacovigilance Agreements with Business Partners
Supervises the allocated medical safety team in the preparation, analysis and presentation of safety information, compilation of highest quality and medical interpretation of safety data in support of safety update regulatory submissions, investigational and new drug applications, and interactions with Regulatory Authorities worldwide.
Anticipates regulatory implications of emerging safety issues and develop strategies for handling/managing such issues, Directs GPSE interactions with Regulatory Authorities
Ensures that GPSE physicians and HCPs are proactively identifying safety concerns and developing contingency strategies that address these challenges.
Assists in optimizing GPSE capacity and capability planning and execution.
Leads and/or contributes to initiatives across disciplines and cross functionally.
Contributes to creating and communicating an environment culture and values which attract, inspire, retain, and develop the most effective talents at all levels to maximize their career development and contribution to the Business.
Medical Degree (MD) required, or internationally recognized equivalent ideally combined with Advanced Degree
10 years+ experience gained in Pharmacovigilance, Clinical Research or Clinical Development within Pharmaceutical industry and/or academia and/or CRO including significant experience in operating in a global pharmacovigilance organization.
Demonstrated knowledge of regulatory agency requirements regarding drug safety and an understanding of general drug safety methodologies.
Ability to comprehend and synthesize complex data and should have experience in the identification, analysis and implementation of programs and procedures required to achieve corporate objectives.
Experience of operating in a multi-disciplinary drug development environment including international experience and exposure to a variety of therapeutic areas.
Experience working in an outsourced environment managing suppliers, CROs, vendors and strategic partnerships.
Identifies opportunities and anticipates changes in the medical safety landscape through an understanding and ongoing assessment of the environment affecting Patient.
Develops partnerships with internal and external stakeholders’ strategic objectives.
Inspires commitment through a wide range of communication channels (meetings, writing, presentations) and demonstrates integrity.
Must have demonstrable experience in people management at a leadership level and well-developed skills in teambuilding, motivating, empowering, and developing people.
Work productively in a fast moving and pressured environment
Good analytical/judgment capabilities to understand, analyze/synthesize, and communicate successfully and concisely.
Well-developed time management skillset to assist prioritization of multiple issues.
Computer literate, including safety database acumen.
Self-resourced, with confidence to take the initiative and act autonomously.
Both facilitates and efficiently leads meetings, both in person and other media
Excellent communication skillset, orally and presentational
Proven ability to work globally and cross-functionally, with strong interpersonal skills /appropriately assertive /team minded and mentoring.
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
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 and a company match of charitable contributions
Family Planning Support, Family Leave
Flexible Work Paths
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Massachusetts - Virtual
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