The vision of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science Franchise, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.
Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to the CSL and Medical Monitor in the execution of Clinical Development functions.
Study Strategy: Drafts development plan under guidance of CSL and/or Medical Monitor. Contributes along with CSL and/or Medical Monitor to development of study design to meet study objectives, development of biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates reference list for study.
Study Planning: Contributes to clinical trial planning including identification of potential risks to study deliverables; development of contingency plan; development of protocol profile, protocol, and ICF template; selection of ARO, CRO, and members for DSMB and/or adjudication committee; development of charters for study committees (e.g., Executive Committee). Provides input to Clinical Operations on monitoring plan (e.g. data fields to be SDV'd) and to Biostatistics on Statistical Analysis Plan (SAP).
Medical monitoring planning: Under guidance of Medical Monitor, contributes to planning, including drafting of medical monitoring plan; drafting the medical monitoring oversight component of study QOP; development of DSMB and/or adjudication committee charters; development of SAE Flow Plan; development of medical content for protocol profile, protocol and amendments.
Study execution: Reviews patient demographics, enrollment, retention and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs before database lock; collaborates with lead statistician on SAP update, as needed. Provides input to Clinical Operations on site issues. Contributes to development of CSR.
Medical Monitoring activities: With guidance of Medical Monitor, monitors lab data and AEs/SAEs; performs and/or reviews drug and adverse event coding; performs medical review of clinical trial data during study conduct and in preparation for DBL; designs tables, listings, and graphs for CSR; performs literature review for assessment of medical issues; drafts patient narratives.
External collaboration: Consults with internal experts and external KOLs for protocol development; provides input on CRO and ARO Scope of Work and budget; participates in study team meetings with CRO and ARO; establishes effective communication with CRO, ARO, and vendors. Meets with commercial group regarding new indications for Life Cycle Management.
Additional non-study related activities: Clinical Development involvement in due diligence activities related to in-licensing and acquisitions. Performs literature review related to new indications for Life Cycle Management.
Minimum MSc or MPH required; PharmD or PhD strongly preferred.
Postgraduate training in TA or related specialty, or equivalent, is desirable
Minimum of 2 years of relevant professional experience is required. 3-5 years preferred.
Excellent oral and written communication skills, strong interpersonal skills; ability to work in a team environment; able to work in a high stress and deadline-driven environment. Energetic, self-motivated and able to multi-task.
Specific competencies: Strategic Thinking, Clinical Trials Knowledge, Influencing Skills, Scientific Knowledge, Therapeutic Expertise, Drug Development, Critical Thinking, Team Leadership
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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. Job Title Manager Oncology R & D
City Basking Ridge
Functional Area Global Oncology R&D
State New Jersey Associated topics: ancmg, aoa, breast, cancer, hem onc, lah, oncology, palliative, radiation, thedacare