Executive Director, Group Leader, Late Development Clinical Science

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Summary

This 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

Accountable for developing the Global Clinical Science Strategy and delivery of clinical studies in late stage development.

Lead and manage the multiple late development and / or transitioned asset Clinical Science Asset Leads 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 GCLs, 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 fulfill their role. Work with RD leaders (including GTLs, Clinical Development leadership, APM leadership) to ensure consistency in support between studies in one or several programs.

Partner and collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs, and other RD functions to ensure effective delivery of transitioning assets from a portfolio level Ensure alignment with other key peer functions (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 Clinical Science Strategy.

In conjunction with Global RD Finance, Global Project Management, HR, manage the workforce planning for Global Clinical Science, operating and capital budgets, resource planning and resource allocation.

Partner closely with CS Chief of Staff to perform ongoing strategic assessment of departmental needs, FTE allocation, budget allocation, and assessment of needs including training, data review tools, etc.

Standing PRG reviewer for mid-to-late-stage asset protocols Core or extended member on Disease Area Strategy Teams (DAST), including lung, breast and emerging priority tumor types Invited member for other RD committees, including but not limited to SCORE, DRF

Create a performance-based team culture with clear accountability and a sense of urgency for achieving results. Lead (recruit, hire, coach, develop, motivate, manage and monitor performance) managers and / or professionals in department specific knowledge, process and procedures.

Sets clear job expectations, provides regular feedback, conducts timely Performance Plan reviews, identifies performance challenges, creates action plans and monitor the effectiveness of those action plans.

Complete Career Planning and competency assessment to ensure professional development of department members.

Ensure that CS are maintaining up to date knowledge of all-important advances within oncology and hematology through scientific literature, attendance at critical meetings and relationships with Key External Experts (KEEs).

Contributes to clinical / scientific training of relevant DS stakeholders on the disease area and compound / Drug. May serve as speaker for program / franchise medical / scientific training

• Guide the Clinical Science staff in the creation of the development strategy ensuring the highest scientific / medical standards in accordance with ethical and regulatory requirements across regions.
• Interact with clinical investigators, academic organizations, co-development partners, and strategic outsourcing. CS Group Lead may establish organization-level relationships with major academic centers globally in partnership with other cross-functional leaders.
• 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
• PharmD or equivalent preferred
• PhD 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
• 10 or More Years with master's degree and relevant clinical oncology experience. Experience with conduct of Ph1-Ph3 studies, including assets transitioning from early to late stage. preferred

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

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.