Job Summary

This position is a Clinical Science lead position and will lead a group of clinical scientists organized around one or more clinical stage assets (including those at the pre-IND stage) within the Global Clinical Science function. This position may be at the executive director level or senior director level, depending on the scope and size of the asset program. This Clinical Science (CS) lead will be responsible for leading and managing one or more clinical scientists, oversee a program of clinical trials from the clinical science perspective, and ensure the writing of high quality clinical trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle. The CS lead will also contribute to the program study strategy, planning, execution and reporting outputs. CS lead responsibilities include overseeing the CS direct reports who will be responsible 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. Depending upon team composition and scope of program, the CS lead may also be responsible for study level clinical sciences responsibilities, as well as clinical and safety monitoring under direct guidance of a physician (Global Clinical Leader or Physician Scientist). The clinical science lead will also participate in the creation and management of new clinical science group from existing pool of clinical scientists, formulate a structure and a resourcing plan, and develop capabilities to serve the needs of the enterprise based on a vision for the function. As a member of the Global Project Team (GPT), the incumbent closely collaborates with the Global Clinical Lead (GCL), the Global Team Leader (GTL), and other members of the GPT and key stakeholders and leaders across the Global Daiichi Sankyo R&D organization to achieve desired business results (short-term, mid-term, long-term).

Job Description

Responsibilities

• Lead and manage a group of clinical scientists organized around one or more assets or therapeutic areas, including integration of regionally based CS’s into a single global CS organization.
• Ensure that adequate (Oncology) Clinical Science resources are deployed to clinical studies from end to end in collaboration with Physician Scientists and the study team (data management, clinical operation and other functions) to implement clinical development plan: study ideation, protocol development, review case report from creation, study initiation, study conduct and oversight (study monitoring, tracking of clinical data), database lock, creating Clinical Study Report, and submission to the Health Authorities.
• Ensure that CS’s within their group receive the necessary training, coaching and support to fulfil their role.
• Work with GCL (and GTL) to ensure consistency in support between studies in one or several programs.
• Partner and collaborate with Clinical Operations, Biostatistics and Data Management, Regulatory Affairs and other R&D functions to ensure effective delivery of one or several oncology assets.
• Ensure alignment with other key peer functions outside R&D (in particular CSPV, QA, and other functions as Pharm Tech SC and biologics, Corporate Business Management)
• Partner and collaborate with global marketing, global medical affairs, global payers and access and commercial business units to ensure unified Global (Oncology) Clinical Science Strategy.
• In conjunction with Global R&D Finance, Global Project Management, HR, manage the workforce planning for Global (oncology) Clinical Science, operating and capital budgets, resource planning and resource allocation.

Responsibilities Continued

Qualifications

Education Qualifications
Master's Degree or equivalent preferred PharmD or equivalent preferred PharmD or equivalent preferred Postgraduate training in oncology or related specialty, or equivalent preferred

Experience Qualifications
7 or More Years relevant clinical oncology experience preferred


Travel Requirements
Ability to travel up to 30% of the time. In-house office position that may require travel (global).

Additional Information