Other Locations:US- CA- San Diego- Science Park
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.
The Director, Translational medicine will support the translational medicine and precision medicine (TPM) efforts across the development portfolio (early through late stage) and be responsible for developing and executing strategies to advance the pipeline from pre-clinical stages into clinical trials and the design and execution of FIH, clinical Proof-of-Mechanism (POM) and/or Proof-of-Concept (POC) studies, as well as supporting late-stage TPM efforts. This role sits within the Clinical Development (CD) organization, which covers all patient studies. Collaborates with other key functions, including Commercial, Clinical Pharmacology (CP), Preclinical Development, Clinical Operations, Medical Affairs, Regulatory and CMC to coordinate and support the TM efforts.
- Provide leadership in TPM across the neurology, gastroenterology, dermatology, and/or rheumatology therapeutic areas.
- Internal subject matter expert for clinical auto-immunity / immunology.
- Generate TPM assessment of new indication opportunities of development candidates and in-licensing opportunities.
- Present results and updates of projects at department, team, corporate and scientific meetings.
- Design and champion compound-centric and disease-centric TPM strategies to senior management that further the corporate goals
- Contribute to the design of FIH, POM, and POC studies for both early and life cycle management (LCM) programs.
- Prepare and/or direct the preparation and review of clinical study reports, and TPM sections of CDPs, IBs, INDs, BLAs, abstracts, manuscripts, and technical reports.
- Execute the TPM strategies, and ensure an integrated (consistent) approach for each development program, from preclinical through registration, and across indications.
- Matrixed management of operational staff responsible for the design, set-up, execution, statistical analysis and reporting of TM studies.
- Identify, contact, discuss, qualify, vendors/CRO’s in the TPM space.
- Review and revise statements of work (SoW), negotiate pricing, and decide on external vendor/CRO contracts in the TPM space.
- Write, read, and/or review statistical analysis plans for TPM studies or sub-studies.
- Review and interpret analyzed clinical trial TPM data to enable timely internal decision-making and external communication with investigators and regulatory agencies.
- Lead the preparation and assure the accuracy of the TPM-section of the clinical study report.
- Collaborate with the Medical / Scientific Communications in support of knowledge generation for the product franchise.
- Generating and packaging content for MoA abstracts, posters, and manuscripts.
- Reviewing IISP’s
- Investigator meetings, advisory boards, CRO selection, site/investigator selection and monitoring
- Other responsibilities as assigned.
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.