Senior Director, Translational Strategy Lead

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Job Summary

The position will define and oversee the translational medicine strategy for a drug program across multiple indications. The successful candidate will set goals and enumerate key scientific questions that will drive clinical development decision-making. In doing so, he or she will align closely with the Global Project Team and Global Team Leader as well as counterparts overseeing research and translational activities in the laboratories in Japan. In addition, he or she will interact with counterparts in the Companion Diagnostics group 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, biomarker statistical analysis plans, and aid in the construction of clinical development plans, clinical protocols, and in the submission of certain regulatory documents, as well as supporting commercial in developing a strategy including patient selection strategy.

Responsibilities

Job Description

• Develop and maintain a translational plan for the program across all indications.
• Define key scientific questions and steps taken to answer them.
• With the Companion Diagnostics group, develop a companion diagnostic plan for the program across all indications as needed.
• Choose developmental paths for the diagnostics including partnerships and external collaborations.
• Identify and interact with key external experts, defining scientific questions to be answered.
• Monitor progress toward goals of external research programs.
• Construct translational plan documents, biomarker statistical analysis plans, and aid in the construction of clinical development plans, clinical protocols, and in the submission of certain regulatory documents.
• Support commercial in developing a strategy including patient selection strategy.
• Construct and co-lead Advisory Panels at certain scientific conferences.
• Lead the Translational Subteam within the Global Project Team for the drug program.
• Present as needed at internal and external meetings.
  
  

Qualifications

Education Qualifications

• Master's Degree required
• PharmD, PhD, MD or equivalent preferred
• Postgraduate training in TA (oncology) or related specialty required
  
  

Experience Qualifications

• 7 years of relevant experience in academia and pharmaceutical industry in translational oncology research with MD or 10 years of relevant experience in academia and pharmaceutical industry in translational oncology research with PhD or Pharm D preferred.
• Demonstrated matrix leadership and ability to define clear 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
• Exceptional communication skills to engage HA and KEEs on complex translational science required
  
  

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.

Salary Range

USD$234,450.00 - USD$390,750.00