Other Locations:US- CA- San Francisco- Owens Street Celgene
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Translational Development Functions:
- Part of the TD Leadership team responsible for defining and positioning the early oncology portfolio in collaboration with VP, Translational Development and colleagues in research, clinical development, and marketing
- Medical lead for clinical trials in hematology and oncology from Candidate Nomination (pre-IND) through Proof-of-Concept including:
- Articulating the clinical development strategy
- Design, implementation and analysis of early stage clinical trials
- Clinical leadership on cross-functional Early Development project teams
- Close liaison with Translational Development Scientists, Discovery and Development Teams for defining Clinical PD or Biomarker assays.
- Responsible for clinical drug safety monitoring and management, in conjunction with the drug safety physician
- Ad Hoc member of the Candidate Development Committee, that evaluates all IND candidates and Early Development programs
- Key resource for disease area expertise for the TD team.
- Liaise with clinical and laboratory-based academic investigators in Early Oncology and be a focal point for defining and establishing relationships with key Global Phase 1 Centers.
- Part of the team responsible for establishing key alliances with academic centers, co-operative groups, vendors and government agencies for cost effective implementation of Celgene’s R & D and early development strategy
- Participate in formulating disease area strategy for target selection and validation
- Provide support to Business Development and the established teams, for potential in-licensing opportunities that may include potential therapeutics, emerging technologies, processes or capabilities that will enhance our Drug Discovery and Early Development efforts.
- MD or M.D./PhD with at least 4 years of post-graduate work experience in Early/Translational Development. Subspecialty board certification in hematology/oncology strongly preferred.
- 6 or more years relevant experience in clinical/translational research with at least 4 years of post-graduate experience working on Translational Development activities (e.g., IND submittals, Proof-of-Concept studies, phase I/II clinical studies, adaptive design studies, biomarker development, companion diagnostics, mechanism of action studies).
- Demonstrated experience interacting with scientists on discovery research and/or translational development projects in hematology/oncology
- Proven record of building, leading and integrating cross-functional groups
- Track record in leading innovative efforts to deploy technologies and assays for enhanced translational capabilities
- Superior leadership, management and organizational skills, and a reputation as an open, available and transparent communicator
- Management experience (through direct reports or matrix organization) coupled with strong interpersonal, oral and written communication skills. Strong leadership in representing Translational Developments positions to Senior Management and Executive Committees and International Forums.
- Ability to interact effectively across boundaries using influencing and relationship building skills.
- Ability to function at the interface of both the Discovery and Development teams, with the aim of providing the successful implementation of stratification strategies, clinical biomarker and pharmacodynamic assays in the early clinical studies
- Competence in analysis and solving of problems, and the ability to prioritize and make tradeoffs to achieve goals.
- Domestic and international travel is expected as required
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.