Manager, Oncology R&D - Clinical Scientist in Basking Ridge, NJ at DSI

Date Posted: 6/25/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years & Counting!

With over 100 years of scientific expertise & a presence in more than 20 countries, Daiichi Sankyo & its 15,000 employees around the world draw upon a rich legacy of innovation & a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension & thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research & 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 & kidney diseases, & other rare diseases.

Job Summary:

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.

Responsibilities:

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.

Qualifications
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • 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.

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.