Senior Director, Translational Strategy Lead

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.

Job Description

Responsibilities

• 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