Senior Director, Translational Strategy, Oncology

at  Daiichi Sankyo Inc

Join a Legacy of Innovation 110 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 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 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:
The position will define and oversee the translational strategy/plan for oncology therapeutic program/s in global R&D. The successful candidate will set goals and enumerate key translational hypothesis that will drive scientific decision-making both from non-clinical and clinical translational aspects. In doing so, he or she will execute a close collaboration with counterparts and internal experts both in the US and Japan, for a tight alignment with the Global Project Team. In addition, he or she will interact with the Companion Diagnostics Lead, Non-Clinical Research, Medical Affairs and other stakeholders to support the program.
Other responsibilities will include, but not be limited to, identifying and interacting with key external experts and monitoring progress toward goals of external research programs. Lastly, he or she will be responsible for constructing translational plan documents and biomarker data analysis plans including interpretation and communication of transactional data and impact to key stakeholders. He or she will aid in the construction of clinical development plans, clinical protocols, and in submission of certain regulatory documents.

Responsibilities:

• Develop and implement a hypothesis driven translational strategy for clinical assets and cross-asset in specific tumor indication/s, defining key scientific questions and plan. Align closely with the Senior Translational Strategy Lead.
• Construct translational plan documents, biomarker data analysis plans, and aid in the construction of clinical development plans, clinical protocols, and in the submission of certain regulatory documents from the translational perspective.
• Provide translational deliverables (e.g. data, reports, and communications) to the Global Project Team to drive scientific decision-making both from non-clinical and clinical translational aspects, through close collaboration with counterparts and internal experts both in the US and Japan (e.g. other translational strategy leads, non-clinical research, translational biomarkers, companion diagnostics, bioinformatics, clinical development, medical affairs, regulatory etc.).
• Identify and interact with key external experts, defining scientific questions to be answered. Monitor progress toward goals of the external collaborations. Establish and maintain effective communication between CRO / vendors / ARO.
• With the Companion Diagnostics Lead, develop a companion diagnostic plan for the program across all relevant indications as needed.
• Leverage disease area strategy or cross-asset strategy by working together with Translational Strategy Leads on other projects, internal and external experts.

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

Education:

• PhD, PharmD or MD degree required

Experience:

• 10 or more years of post-doctoral and relevant industry experience with expertise in translational research, biomedical leadership and human translational research in clinical trials required.
• Demonstrated ability to define clear clinical trial translational strategies anchored in disease biology and drug mechanism of action, aligned with clinical development.
• Deep knowledge in biomarker technologies including NGS, immunoassay, proteomics, immunohistochemistry including assay validation required.
• Extensive experience in the discovery, characterization, and utilization of innovative translational strategies across the continuum of research/preclinical and clinical stages preferred.
• Experience/knowledge in companion diagnostics device development preferred.
• Demonstrate flexibility to work on more than one project.
• Demonstrated excellence in developing and implementing overarching therapeutic area translational strategies.
• Demonstrated excellence in independently leading and conducting research and ability to evaluate, interpret and present complex scientific data.
• Excellent leadership skills including motivation and delegation.
• Excellent verbal and written communication and presentation skills in English.
• High level of initiative and ability to work independently and in a cross-functional management team.
• High level of business awareness.

Travel:

• Global travel is required ~10%

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

• Develop and implement a hypothesis driven translational strategy for clinical assets and cross-asset in specific tumor indication/s, defining key scientific questions and plan. Align closely with the Senior Translational Strategy Lead.
• Construct translational plan documents, biomarker data analysis plans, and aid in the construction of clinical development plans, clinical protocols, and in the submission of certain regulatory documents from the translational perspective.
• Provide translational deliverables (e.g. data, reports, and communications) to the Global Project Team to drive scientific decision-making both from non-clinical and clinical translational aspects, through close collaboration with counterparts and internal experts both in the US and Japan (e.g. other translational strategy leads, non-clinical research, translational biomarkers, companion diagnostics, bioinformatics, clinical development, medical affairs, regulatory etc.).
• Identify and interact with key external experts, defining scientific questions to be answered. Monitor progress toward goals of the external collaborations. Establish and maintain effective communication between CRO / vendors / ARO.
• With the Companion Diagnostics Lead, develop a companion diagnostic plan for the program across all relevant indications as needed.
• Leverage disease area strategy or cross-asset strategy by working together with Translational Strategy Leads on other projects, internal and external experts