About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.
Senior Director, Translational Science - DS-8201
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.
Trastuzumab deruxtecan (DS-8201a) has demonstrated significant preliminary clinical activity in patients with a range of HER2 overexpressing tumors including breast cancer, gastric cancer, NSCLC, colorectal cancer, salivary gland cancer, cholangiocarcinoma, Paget's disease and other tumor types. In addition, the drug has demonstrated clinical activity in patients with low expressing HER2 breast and gastric cancers as well as in NSCLC patients with HER2 mutations. Pivotal global clinical development of trastuzumab deruxtecan is ongoing in patients with HER2 overexpressing breast cancer and gastric cancer. However, as the drug may benefit a number of additional patients, a global clinical translational development plan must be defined and managed to help these patients with unmet medical need.
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 the trastuzumab deruxtecan drug development program. 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 trastuzumab deruxtecan.
- 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 Oncology or Hematology, 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.