Join a Legacy of Innovation 110 Years and Counting!
With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 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 hypertension and thrombotic disorders, under the Group's 2025 Vision to become a \"Global Pharma Innovator with a Competitive Advantage in Oncology,\" Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.
A pan- ADC MD leadership position reporting through R&D which leads an across-enterprise-approach to safe use of DS-8201 and all other ADC's. This position complements CSPV efforts with a more comprehensive and all-encompassing approach to coordinate activities across key functions to minimize ILD in patients treated with ADC's throughout the course of clinical development through the commercial setting.
Conceive, build and lead an empowered ADC-ILD Task force comprised of various stakeholders including but not limited to Safety, stats, reg affairs, translational Research and Science, QCP GMA, clin Ops, HEOR, and Strategic commercial. Report status of initiatives and update on progress to senior R&D Leadership (via GEMRAD, GRDC).
Design and implement an overarching safety program tailored for ILD from end-to-end: understanding predisposing non-clinical and clinical factors, diagnosis, effective management during clinical trials and beyond in post approval setting.
Develops prospective contingency plans for management of key safety (focused on ILD) risks across ADC projects; Clearly defines priorities and high-level execution plans across and effective alignment within (e.g. with translational research, clinical operations, clinical development, medical affairs CSPV and other internal groups) and outside of Daiichi Sankyo (e.g. clinical trial sites, CROs, collaboration partners); Supports effective direct communication with clinical sites in collaboration with CSPV staff.
Consults with KEE's for advice on complex patient safety issues, especially ILD. Communications lead with HCP's (PI's, sub- PI's, nurses) at the site level to ensure that patient safety (especially with respect to ILD) remains top of mind in the context of patient management in the clinical trial setting and in the real-world setting.
Fully elucidate Mechanism of Action of ILD. Works closely with pre-clinical safety to identify and mitigate potential patient safety issues (especially related to ILD) prior to FIH trials
With a strong focus on ILD, responsible for message development and execution of key safety initiatives aimed at preventing, mitigating, and addressing critical safety issues including but not limited to protocol amendments, Dear HCP letters and key medical education initiatives
Qualifications Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
MD with substantial industry-based experience in Oncology clinical development & safety, Board certified oncology MD preferable but not necessary. An impeccable oncology clinical and medical expert with proven credibility and experienced in patient safety and clinical operations.
8 years (3 years managing Clinical Development group)
Strategic Thinking, Clinical Trials Knowledge, Influencing Skills, Scientific Knowledge, Oncology Therapeutic Expertise, Drug Development, Critical Thinking, Team Leadership
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.
Job Title Executive Director, Clinical Team Lead Patient Safe Use
City Basking Ridge
Functional Area Global Oncology R&D
State New Jersey Associated topics: biopharmaceutical, clinical, dietician, drug discovery, health, histology, immunohematology, immunology, transfection, vaccine
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.