Daiichi Sankyo Inc. • Basking Ridge, NJ 07920
Job #2695393195
Join a Legacy of Innovation 110 Years and Counting!
Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science function. He/she will be responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will be responsible for overseeing multiple program-level CS Asset Leads who are managing a team of clinical scientists for the writing of protocols / amendments and associated documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA responses. Interactions with the internal clinical study physicians and physician scientists as well as external investigators is expected. The CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle is optimized across multiple programs. The CS group lead will also contribute to the program study strategy, planning, execution, and reporting outputs in collaboration with the CS Asset Leads. The CS Group Lead will also contribute to evolving and strengthening the clinical science group from existing pool of clinical scientists, formulate an optimal structure and a resourcing plan, and develop capabilities to serve the needs of the enterprise, especially the transition of rising star early assets to late phase development, based on the vision for the function. As the late development CS Group Lead, the incumbent closely collaborates with the key stakeholders and leaders across the Global Daiichi Sankyo R&D organization to achieve desired business results (short-term, mid-term, long-term). These will include but not limited to Group Heads in Clinical Development, Asset & Portfolio Management, Global Clinical Operations, BDM and DLT members. He/she will also serve as the Clinical Science representative or delegate at key R&D forums/groups such as Development Review Forum (DRF), Protocol Review Group (PRG) and SCORE. As a core or extended member of the Disease Area Strategy Team (DAST), the CS Group Leader will collaborate closely with other members of the DAST to provide synthesized and aligned guidance to asset teams to enable seamless tumor-specific clinical development and strategy.
Responsibilities
Contribute to Clinical Development initiatives, global education, and process development projects, as required. May serve on or lead global initiatives (e.g., process improvement, Protocol review, training, SOP development, other Clinical (oncology) Development line function initiatives) and represent the function on various leadership teams and committees. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)
Master's Degree or equivalent preferred
Postgraduate training in oncology or related specialty, or equivalent preferred Experience Qualifications
10 or More Years with PharmD, PhD and relevant clinical oncology experience preferred
At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee's unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.
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