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Senior Director GMA Oncology - Real World Evidence in Bernards, NJ at DSI

Date Posted: 5/6/2019

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

The Sr. Director, GMA Oncology Real World Evidence (RWE) is responsible for defining and developing RWE strategies for the Oncology portfolio as part of evidence generation strategy of GMA plans. He/she will work in close collaboration with Franchise Head, GMA TA leads and other global functions such as R&D, HEOR/Market Access, Pharmacology, and Epidemiology, as well as regional medical to identify data gaps and generate evidence or information from non-conventional clinical trial, to inform our internal and external stake holder for their decision making. This individual will work with the GMAT Leads and the clinical operation teams to ensure seamless execution of the RWE medical programs defined in the GMA plans, including but not limited to, randomized trials, non-interventional, observational studies, and real-world data sources. The individual will work with internal business partners and will participates in cross functional teams and committees to contribute to the overall Oncology evidence generation plans. Develops strong internal and external relationships ensuring scientific and medical rigor as it relates to RWE.

Responsibilities:
  • Develops GMA Oncology Real World Evidence Strategies:
    • Develops an integrated RWE generation strategy and plan across the Oncology portfolio as part of the overall GMA Evidence generation strategy and plan including concepts for randomized trials (e.g., large simple trials, pragmatic clinical trials), non-interventional, observational studies (prospective or retrospective), and real-world data sources.
    • Incorporates the use of electronic medical records, mobile health technology, and other electronic data-capture technology into study concepts using real world data.
    • Develops plans to generate supportive evidence on the safety and effectiveness of Daiichi-Sankyo Oncology products, including analysis and use of real-world data sources.
    • Works collaboratively with key internal and external stakeholders, such as GMA TA lead, R&D, HEOR/Market Access, Pharmacology, and Epidemiology and key external experts in the field of RWE.
    • Aligns the global strategies with regional needs to ensure relevance of the generated evidence to regions and countries.
    • Partner with regional and cross-functional colleagues to provide expert review and guidance on evidence generation activities to ensure robust methodology and alignment with global RWE strategies
    • Key member/contributor of DSI’s cross functional RWE steering committee ensuring alignment in any RWE strategies/integrated evidence generation plans
  • Implementation of GMA Oncology RWE Strategies:
    • Assesses vendor/CRO capabilities to conduct clinical trials and noninterventional studies.
    • Provides input on study design, protocol and analysis plan development, and facilitates review and approval of relevant study documents.
    • Leads execution, vendor oversight and budget management of RWE projects from end to end.
    • Works with relevant GMA and other internal stakeholders to appropriately communicate the evidence generated to relevant external stakeholders (patients, providers, regulators, payers).
    • Search and explore new cutting-edge technology including, not limited to, biomarkers/omics to meet with the need from GMA TA lead, GPT lead and other functions leadership.
Qualifications
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • Minimum of Master’s degree in Health Science required (Clinical Leadership, Clinical Research, Public Health, Epidemiology or related discipline such as Outcomes Research). Ph.D. degree preferred.
  • Ph.D.: 7+ years of relevant experience, including a minimum of 5 years in the pharmaceutical/biotechnology industry.
  • Master's degree: 10+ years of relevant experience, including a minimum of 5 years in the pharmaceutical industry
  • Knowledge of Oncology therapeutic area and previous clinical development/operations experience is strongly preferred
  • Fluent English (oral and written)
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.