Vice President, Global Head Oncology Clinical Science

Join a Legacy of Innovation 125 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.   

Job Summary:

This position will lead the global clinical science function within global development for both Oncology and Specialty Medicine (Non-Oncology).  Lead the global group of Clinical Scientists (CS) responsible for oversight of clinical study from clinical science perspective and ensuring high quality clinical trial protocols, clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle and for contributing to study strategy, planning, execution and reporting outputs. CS responsibilities include leading 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 external investigators is expected.  Depending upon team composition and scope of program, the CS may also be responsible for clinical and safety monitoring under direct guidance of a physician (Global Clinical Leader or Physician Scientist).

The head of clinical science will be responsible for staffing the function from the existing pool of clinical scientists and recruiting new talent as needed, adapting the structure of the function as needed to support organizational growth, and developing capabilities to serve the needs of the enterprise based on a vision for the function.

As a member of the Global Oncology Development Leadership Team, the incumbent closely collaborates with the Global Head of Oncology Development, R&D leaders including GTLs and GCLs, key stakeholders and leaders across the Global Daiichi Sankyo R&D organization to achieve desired business results (short-term, mid-term, long-term) for both early and late-stage oncology.  In addition, the incumbent will be asked to oversee and staff a pool of clinical scientists that support conduct of early-stage non-oncology trials.

Responsibilities:

Accountable for developing the Global Clinical Science Strategy and delivery of clinical studies:

• Ensure that adequate 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, inspection readiness), database lock, creating Clinical Study Report, and submission to the Health Authorities.

• Work with GTL and GCL to ensure consistency in support between early and late development.

• Partner and collaborate with Clinical Operations, Biostatistics and Data Management, Regulatory Affairs and other R&D functions to ensure effective delivery of the global portfolio.

• 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 Clinical Science Strategy.

• As needed, partners and collaborates with senior leaders including business development on potential external partners/acquisitions/collaborations to optimize the value of the global portfolio.

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

• 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 a given disease area 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. Serve as Primary Liaison for all (Oncology) acquisition & Licensing opportunities when required.

• Contribute to Clinical (oncology) 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:

• Master's Degree Graduate degree in a scientific discipline required and

• PharmD preferred or

• PhD preferred

Experience:

• 10 or More Years Clinical (oncology) development experience required in clinical science in a global setting

• Management experiences

• Experience developing a network of individuals from various departments important to job function including clinical operations, regulatory affairs, data management, statistics, and other R&D and non-R&D functions.

• Experience interacting with key academic investigators

• Experience leading and managing global strategic initiatives

• Demonstrated track-record of complex decision making, communication and collaboration skills with proven cross-functional and multi-level relationship building and stakeholder management skills

• Experience with workforce planning and managing operating budgets with varying degrees of complexity

• Experience leading global teams and operating in a matrix environment

Travel:
 

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.