GILDJP00017222 A. Director of Clinical… at Management… · Remote

This is a remote position.

Additional Notes:

GILD

ROLE IS FULLY REMOTE

See below for resume summaries of previously selected candidates:

A. Director of Clinical Operations and Clinical Research Scientist with over 23 years of research experience and over 19+ years of experience in the design, conduct, and data review for clinical studies from Phase I through Phase IV. Integral member of submission team on successful BLA and sBLA for CAR-T therapy (Abecma). Experienced in a broad range of therapeutic areas including: Hematology/Oncology (CLL, MM), Oncology (HCC, NSCLC, Renal, Late Stage Solid Tumor), Neuroscience (Alzheimer’s Disease, Major Depressive Disorder, Epilepsy, Tourette Syndrome), Infectious Disease (HIV, HCV), Respiratory (COPD, Asthma), Dermatology (Psoriasis), Gastroenterology, Cardiovascular, Immunology and Rare Disease (Dravet).

Bristol-Myers Squibb Clinical Research Scientist Review hematology/oncology studies in Multiple Myeloma for Abecma (CAR-T studies) in Phase II-III. Responsible for review of 200+ patients globally across multiple studies Review patient profiles, data listings and JReview generated listings to issue clinical queries and assist sites, as needed, in responding to clinical queries. Collaborate with both CRO partners and internal team members to deliver high quality data (TFLs) in support of a BLA and sBLA submission and subsequent FDA approvals (2021 and 2024) as well as approvals by PMDA and EMA in a relapsed refractory patient population. Regulatory/Submission experience includes (BLA and sBLA for Abecma): USPI and European label revision, information request response generation for multiple regulatory bodies, FDA requested narrative generation, meeting preparation (ODAC and SAGO) for successful approvals in both US, Europe and Japan (2021 and 2024). Experienced in reviewing: response data (IMWG criteria), eligibility criteria, previous therapy, safety (AE/SAE review, cytokine release syndrome, and neurotoxicity), coding and protocol deviations. Experienced in setting up and managing DSMB and Adjudication Committees. Highly skilled at writing protocols, ICF templates, IB updates, DSURs, briefing books, monitoring plans, and investigator and training materials.

B. Clinical Research Professional with substantial background in pharmaceutical industry and proven talents in clinical data review, data management, performance management, CRO oversight, training, and team motivation. Extremely well-versed in R&D operations in clinical development phases I-IV; specialization in Hematology/Oncology, Men’s and Women’s Health, Endocrine, Internal Medicine, Anti-Infective and CNS drug development. Efficient in clinical data review and reconciliation, including safety and efficacy variables, laboratory data; data analysis and reporting, development of CRFs and database build activities. Adept at leading cross-functional teams throughout clinical studies with full accountability for project management and regulatory compliance across protocols. Extensive talents in developing clinical development plan, managing vendor relationships, ensuring patient safety with advanced knowledge of GCP/ICH and regulatory processes. Optimize clinical program performance by building unified relationships with key stakeholders.

Genmab, Clinical Research Scientist – Non-Hodgkins Lymphoma (Aug 2022-Present) Works in collaboration with Medical Director and other Senior level Clinical Research Scientists. Participates in the development of case report forms (eCRFs), eCRF completion guidelines, and provide scientific support for other key data management deliverables (e.g. database lock activities). Contribute to the medical data review plan, perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis. Perform data reconciliation and query generation in eDC databases; generate JReview listings to identify data trends.