Director, Safety Pharmacoepidemiology応募後で応募 求人ID R0024739 掲載日 11/10/2020 Location:Boston, Massachusetts
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director, Safety Pharmacoepidemiology in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
Safety Pharmacoepidemiology (SPE) is an internal, client-facing research and advisory function within R&D to thoroughly understand regulatory/business priorities and address pharmacoepidemiology research opportunities.
The Director Safety Pharmacoepidemiology is responsible for providing strategic planning and project/thought leadership internally and externally in the following areas:
- Disease epidemiology/pharmacoepidemiology to support epidemiological benefit-risk assessments across Takeda portfolios.
- Collaboration across Clinical Science, Global Medical Affairs, Marketed Products Group, Global Regulatory Affairs, and Global Patient Safety Evaluation in the writing and reviewing of protocols, epidemiological study reports, and presentation of scientific findings to regulatory authorities, medical professionals and others.
- Development/adoption of epidemiological research methodologies, epidemiologic strategies, observational studies and the generation of use cases for regulatory application of risk and effectiveness characterization.
- Collaboration with a multidisciplinary, matrixed organization, to ensure product priorities and strategies are aligned to meet evidentiary requirements/needs to defend product benefit-risk profile for multiple products within and across Takeda product portfolios
- Contribute to the continuing education of relevant line functions on the use of pharmacoepidemiology methods and study designs
- Support multiple product teams on pharmacoepidemiology/product-safety related issues
- Develop and implement strategic communication plans to educate Takeda stakeholders of the value, opportunities, data, methods, analytics, and processes that SPE can provide to assess and identify product value for internal and external stakeholders (patients, healthcare providers, regulators, HTAs/payers, and other healthcare decision makers), from early development through launch and commercialization of Takeda products
- Develop effective relationships with external audiences and partners thought leaders in pharmacoepidemiology, comparative effectiveness research, health informatics, and data sciences to maintain an extensive understanding of the external environment and create opportunities for engagement
- Effectively manage external research partners to ensure projects are scientifically rigorous, medically relevant and address business needs as well as the needs of patients, healthcare providers and payers.
- Provide relevant input into clinical development plans, evidence generation plans, regulatory documents with accuracy and scientific integrity
- Prepare and/or review pharmacoepidemiology research protocols, statistical analysis plans (SAPs), and reports reflecting ongoing or completed work.
- Effectively communicates study findings to internal and external audiences, and as appropriate in conference presentations, publications, and dossiers/documents to regulators and/or other regulatory authorities.
- Compliance with all policies, regulations and appropriate guidelines for the conduct of pharmacoepidemiology studies
- Accountable for product annual plan budget and contract/budget management.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Combination of academic training and practical experience in epidemiology and/or pharmacoepidemiology is required. This may consist of:
- Doctoral degree (e.g., Ph.D., Sc.D. or Dr.P.H.) in a relevant discipline such as, but not limited to, health services research, epidemiology, pharmacy administration, statistics or decision sciences, plus 8+ years practical experience
- Master’s degree in a related discipline (as noted above), plus 10+ years practical experience.
- Practical experience (years noted above in performing epidemiology and/or pharmacoepidemiology in any setting, including life sciences company, pharmaceuticals, research organization, academic institution or governmental agency, is required.
- Drug development experience is required
- Demonstrated experience in the conduct of complex observational studies/registries and the interpretation and communication of study findings to internal and external audiences. Employs advanced technical expertise to solve research questions/problems.
- Ability to understand regulatory challenges for Takeda products as well as interacting with regulators or other decision makers is required
- Ability to work collaboratively and effectively in a multicultural and cross functional matrix team environment is expected.
- Broad experience in collaborating with research partners and in managing multiple tasks and complex projects is required
- Ability to communicate scientific evidence, with strong written and verbal presentation skills, is required.
- Record of high-quality, peer-reviewed publications is preferred.
- Ability to influence without authority, particularly individuals at senior levels
- Time commitment expected for travel is approximately 25% - 50% domestic and international.
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
Discover more at takedajobs.com
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