Celgene Sr. Director, Head of Biotherapeutic Bioanalysis in Summit, New Jersey
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 Senior Director, Biotherapeutic Bioanalysis, is responsible for scientific and administrative leadership of the function responsible for preclinical pharmacokinetics and preclinical/clinical bioanalysis of all Celgene Biotherapeutics portfolio programs. This individual works closely with colleagues from Biotherapeutics Discovery, Nonclinical and Clinical Development teams to develop strategy and execute it to advance Celgene Biotherapeutics portfolio.
Leads Biotherapeutic Bioanalysis function responsible for preclinical PK, bioanalytic and immunogenicity assessments for entire biotherapeutic portfolio, which includes a wide range of modalities such as monoclonal antibodies, fusion proteins, ADC and cellular therapies
Represent DMPK function on cross-functional project teams and provide functional expertise to advance project goals
Recruit and mentor high quality scientists, and champion their career progress
Manage functional resources, prioritization and project deliverables
Ensure robust oversight of GLP bioanalysis conducted at CROs
Author and/or review regulatory submission documents, and either directly or via direct reports interacts with regulatory authorities to address relevant issues
Provide input on evaluation of external assets, and work with Alliance Partner counterparts to ensure smooth transition of assets to Celgene.
Be a scientific thought-leader in the area of expertise
Assist establishment of NCD long term goals, devise and execute plans of action
Enhances the scientific credibility of Celgene through publications/presentations, academic and consortia interactions
The position requires an individual with:
An advanced graduate degree in a relevant field (Ph.D., or equivalent) with world-class expertise in biotherapeutic pharmacokinetic and immunogenicity assessments and an excellent understanding of the drug development process
Knowledge and experience in flow cytometry, quantitative PCR and quantitative immunoassays and their applications to the development of cell therapies
Advanced knowledge of regulatory & standard industrial practices in biotherapeutic bioanalysis
Proven ability to identify and solve issues in a timely manner and positively impact project progress
Demonstrated managerial, leadership and supervisory skills
Excellent communication and interpersonal skills to effectively represent function at internal working groups/project teams, senior management and with external partner / academic / industrial / regulatory organizations
Domestic and international travel is mandatory 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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.