CLINICAL OPERATIONS & PROJECT MANAGEMENT
- Seasoned, hands-on clinical operations / project management leader for nearly 25 years, expert at building cohesive, high-performing teams and leading drug development Phases 1-4 through post-approval..
Clinical Operations, Project Management, Clinical Trials Oversight, Clinical Strategic Planning, Quality Operations, IND Preparation / Submission, Budget Management / Analysis, Leadership, Drug Development SOPs and ICH / GCP Guidelines, CRO / Vendor Selection / Management, and Internal Review Committees.
Therapeutic areas: oncology, endocrinology, neuroscience, cardiovascular, immunology, and ophthalmology.
Interim Head of Clinical Operations, Vigeo Therapeutics, Inc.
Senior Director, Clinical Development Operations, Oncolys BioPharma, Inc.
Provided strategic clinical leadership for clinical development / medical affairs activities for early- and late-stage development portfolio in immuno-oncology. Contributed medical strategies / tactics, including early Phase 1b/2 and late-stage 2/3 for Investigator-initiated and company studies.
Senior Director, Medical Affairs, Operations, Ipsen Biopharmaceuticals, Inc.
Led Clinical Project Management and Quality Operations. Oversaw clinical studies across three products: Somatuline Depot® (oncology – GEP-NET and Lung-NET) and endocrinology (Acromegaly), Onivyde® (Pancreatic adenocarcinoma), Increlex® (endocrinology – lifecycle development planning), and Dysport® (neuroscience – pediatric lower limb spasticity). Operations lead for Onivyde® transition from Merrimack to Ipsen. Chaired four internal review committees for educational grants, investigator-initiated studies, medical information review, and study review. Performed budget management and analysis. Led analysis and revision of procedures and policies.
Senior Director, Clinical Operations, GTx, Inc.
Managed oncology Clinical Operations team, initiating two global breast cancer clinical trials with GTx-024(novel SARM). Developed and implemented CRO selection process, and oversaw central laboratories, and imaging and data management services. Corrected recruitment challenges. Led SOP / WI revisions.
Clinical Operations Consultant, ReSearch Logix, LLC
- Consultant, NSCI Group: Prepared initial draft of protocol, case report form, and subject consent for Bayer Healthcare CTEPH observational study, and confidentiality agreements for 150 potential study sites for Bayer Phase 4 pulmonary hypertension trial.
- Interim Vice President, Clinical Operations, Deciphera Pharmaceuticals, LLC: Built Clinical Operations team. Part of IND preparation and successful submission for DCC-2701 in three months with minimal staff. Executed first-in-human Phase 1a/b study of DCC-2701, a MET/TIE2/VEGFR2 kinase inhibitor, in solid tumors. Collaborated with senior staff to guide clinical development plans around strategy, timelines, resources, and tactics.
- Head Consultant, WindMIL Therapeutics: Set framework for Clinical Operations execution of Phase 1/2 clinical trial for use of marrow-infiltrating lymphocytes in lung cancer.
- Consultant, Aleta Biotherapeutics: Prepared clinical operations timeline, budget, and resource estimates for Phase 1/2 clinical trials for multiple hematological cancer indications (adult and pediatric).
- Consultant, Espero Biopharm, Inc: Prepared clinical operations timeline, budget, resource, and outsourcing estimate for Phase 3 clinical trials for coagulation in patients with renal disease and atrial fibrillation.
Vice President, Clinical Operations, Lux Biosciences, Inc.
Provided leadership, strategic planning, and effective management and guidance to study management, clinical monitoring, and data management staff. Oversaw the execution and database lock of the final Phase 3 pivotal study in non-infectious uveitis. Developed strong team and reorganized reporting structure.