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.
SPECIFIC DUTIES: • 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.
About Celgene Corporation
Celgene CorporationDriven by PASSION FOR THE PATIENT.
-Preeminent Global Biopharmaceutical Company- ~8,000 Employees Worldwide- Operations in >60 countries and sales in >70 countries.
-Focused on Discovery, Development and Commercialization of Innovative Therapies for Unmet Medical Needs in Cancer and Immune-Inflammatory Diseases.
- 8 marketed products (hematology, oncology and immunology)- Focused on R&D; >30 Phase III programs underway and 300+ clinical trials
- Diverse technology platforms and commitment to sustaining innovation