Senior Director, Translational Science - AML
Daiichi Sankyo Cancer Enterprise has a bold ambition to become a leading world- class organization in oncology based on 3 pillars: Antibody Drug Conjugates, AML and Breakthrough Science. To that end, we are looking for Translational Science leaders to help us quickly progress our new medicines from Discovery through clinical development and to registration.
The Cancer Enterprise AML franchise is pushing the boundaries of science aiming to define a new standard of care for patients with AML. Our AML pipeline currently has 5 compounds in the clinic across three mechanisms of action: Quizartinib (FLT3 inhibitor) in phase 3 development and Milademetan (DS-3032; MDM2 inhibitor), DS-3201 (dual inhibitor of EZH 1/2), PLX51107 and PLX2854 (BET / bromodomain and extra-terminal inhibitors) and DS-1001 (IDH1 inhibitor) in early clinical development.
This newly created position will be responsible for creating the strategy and will have programmatic responsibility for the Translational Science (TS) plan that will be incorporated into drug development programs of our key AML clinical assets within the Cancer Enterprise. The TS plan will include all aspects of pharmacodynamic and clinical biomarkers, companion diagnostics and nonclinical biology research needed to inform development decisions throughout the development life-cycle. The selected candidate will report to the Global Head of Oncology Translational Development.
The candidate will work in collaboration with other members of global Daiichi Sankyo functional areas including preclinical research, biomarker research (BM/CDx/Ops),
CDx development, safety, clinical pharmacology, and global clinical development. The candidate will be a core member of the global program team and, depending on their potential and experience, lead the global translational sciences subteam.
Close interaction with global functions in Japan, US and Europe will be a key part of this job, as well as developing and maintaining strong collaborations and relations with external top scientists and physicians (including representing DS at key congresses and meetings).
This position is based in Basking Ridge, NJ; Travel expected to be ~ 30%
- Lead translational science activities in Cancer Enterprise by leading cross-functional groups in global Daiichi Sankyo
- Develop and implement translational science strategies supporting oncology projects in early to late stages of drug development.
- Plan and implement translational research including investigation of mechanism of action, mechanism of resistance, pharmacodynamics markers of target engagement, markers predictive of or correlating with clinical efficacy, and disease biology, in cooperation with preclinical research, biomarker group, clinical pharmacology and clinical development teams in the US and Japan. Work in conjunction with the biomarker lead on considering feasibility, execution and operations and with the CDx lead to support the CDx plan.
- Work with pre-clinical research teams to initiate TS planning of pre-clinical assets in order to establish the foundation for, and assays to support, the clinical program.
- Build and maintain strong relationships and collaborations with key scientific and medical experts to incorporate external insights and maximize the generation of scientifically robust data to accelerate our drug development programs.
- The candidate will be a core member of the global program team and may lead the global translational research and development subteam.
- The position, in partnership with the Global Clinical Lead, will be the single point of accountability for the translational science plan for our AML Franchise.
- Develops translational science strategy supportive of commercial landscape and needs.
- May be involved in Business Development activities for late stage compounds; Potential involvement with due diligence activities to support in-licensing and acquisitions.
Experience and Required Skills
- PhD, MD, or PharmD with 8 or more years of related experience post-degree. For exceptional individuals with an MS, 10+ years' experience post degree. MD/PhD preferred.
- 5-10 years experience of applied translational science activities for clinical assets, including strategy, contracting, validation and implementation of biomarkers and patient selection assays for incorporation into multisite clinical trials.
- Knowledge and expertise in AML and/or hematological malignancies, with a strong publication track-record and reputation.
- At least 3 year's experience in a biotech or pharmaceutical company is preferred.
- A strong preference for a candidate with broad connections to globally-recognized scientific or medical research leaders.
- Ability to work independently as well as collaboratively in an international matrixed team environment.
- Strong communication and presentation skills. Fluency in oral/written English. Japanese language skills are a meaningful plus. Strong interpersonal skills and knowledge of intercultural differences.
- Strong organizational and networking skills.
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.