Executive with over thirty years of biotechnology experience managing Phase I through Phase IV Clinical Trials and over 20 years of formal supervisory experience in clinical operations. Persistent leader eager to lead and grow organizations. Skilled in strategic planning, problem-solving, and communication with good understanding of business principles, project management and team leadership. Collaborative with relentless work ethic.
Overview
36
36
years of professional experience
Work History
Vice President, Clinical Operations
Iambic Therapeutics, Inc.
06.2023 - 12.2023
Serve on the executive leadership team contributing overall strategic planning, oversight and delivery of Iambic's clinical programs where drug discovery occurred through artificial intelligence (AI)
Responsible for establishing the clinical operations infrastructure including developing SOPs, clinical forms and templates; developing departmental budget; identifying, selecting and managing CRO and vendors; collaborating with cross-functional department heads to assure quality operations and compliance to GCPs/ICH guidelines and other relevant regulations for all clinical programs
Responsible for identifying resource gaps, hiring staff, providing leadership, training and mentoring.
Vice President, Clinical Operations
Pionyr Immunotherapeutics, Inc.
08.2020 - 06.2023
Accountable for the overall operational strategic planning, oversight and delivery of Pionyr's clinical programs; contributes to the overall strategic clinical development plans; develops and manages program budgets; collaborates on interdepartmental translational research and medical activities specific to implementation and conduct of clinical programs; responsible for identifying resource gaps, hiring staff, providing leadership, training, mentoring and performance management to clinical operations staff; contributes to IND submissions, responding to agency questions, and IND Annual Reports; serves as an escalation point for vendor management issues/concerns; ensures the clinical operations staff provides adequate oversight of the Contract Research Organization (CRO) to ensure deliverables are met in a timely manner and within budget, and serves as the Clinical Operations Team Leader accountable for cross-functional team deliverables to ensure Corporate Goals are achieved.
Sr. Clinical Consultant
Pionyr Immunotherapeutics, Inc.
10.2019 - 08.2020
Senior consultant responsible for managing a lead anti-PD1 candidate, which entails contributing to the overall strategic clinical development plans; contributing to PreIND submissions; developing and contributing to Clinical Standard Operating Procedures (SOPs) and clinical templates; and assessing and managing external resources (e.g., Contract Research Organizations (CROs)).
Sr. Clinical Consultant
Beigene Ltd.
- 10.2019
Regional Lead responsible for the US/EU for an Oncology first line Hepatocellular study
Responsibilities included: managing external resources (i.e., Parexel and ClinEdge); providing regional status updates to global project team, clinical study team and program partners; constant communication with the investigators to increase enrollment and address site specific issues; reviewing monitoring reports; reconciling temperature excursions; presenting at investigator meetings, steering committee meetings, and data review committees; and providing input into the protocol, CRFs, and investigator brochures.
Sr. Director, Clinical R & D
Agensys Inc.
10.2007 - 12.2017
Managed multiple Oncology clinical programs for monoclonal antibodies and antibody drug conjugate candidates (ADCs); contributed to the overall strategic clinical development plans; developed and managed program budgets; consulted with the pharmacokineticist and toxicologist to determine appropriate first in man doses; collaborated on interdepartmental translational research and medical activities specific to implementation and conduct of protocols; prepared Clinical Study Reports; provided leadership and mentoring to direct reports; contributing to IND submissions; assessed and managed internal resources (human and monetary) and external resources (e.g., consultants and Contract Research Organizations (CROs)) and served as Project Team Leader accountable for cross-functional team deliverables to ensure Corporate Goals are achieved.
Director of Project Management, Medical Affairs
Amgen Inc.
01.1996 - 10.2007
Provided project management support to the Oncology Therapeutic Head, which entailed contributing strategically to the operations of the Oncology Therapeutic Area (TA) and management of the department budget, planning and facilitating physician meetings, physician off-sites, and team building events; assisted with assessing and managing resource allocation (i.e., financial and human resources); ensured effective communication between the TA Head and staff physicians; and drove implementation of process improvement initiatives resulting from capacity analysis, benchmarking and metric reports
In addition, I directly managed Senior Project Managers that provided full project management support to the Medical Affairs Teams (MATs) using a full array of Project Management tools (e.g., MS project timelines, risk assessment and logs, change control logs, and action item logs)
Responsible for the largest Phase 4 clinical study, at the time, at Amgen.
Sr. Clinical Research Associate
Genentech Inc.
03.1988 - 01.1996
Supported Phase 2 and Phase 3 clinical trials with IGF-1 and Human Growth Hormone in Respiratory Failure and short stature clinical trials, respectively
Managed internal CRAs and external CRO's
Assisted in the design, implementation and scientific monitoring of clinical trials, including the analysis and reporting.
Education
Executive MBA -
Pepperdine University
Malibu, Ca.
05.2005
Bachelor of Science - Biology
San Francisco State University
San Francisco, Ca.
06.1985
Skills
Clinical Operations
CRO Oversight
Vendor Management
Contract Negotiations
Team Leadership
Relationship Building
Risk Management
Decision Making
Affiliations
American Society of Clinical Oncology (ASCO)
Drug Information Association (DIA)
Alpha Kappa Alpha Sorority, Inc.
Therapeutic Experience
Oncology: Renal Cell Carcinoma, Bladder Cancer, Hepatocellular Carcinoma, Ovarian Cancer, Non-small cell lung cancer (NSCLC), Pancreatic Cancer and other advanced solid tumors
Nephrology
Rheumatology
Infectious Disease
Endocrinology: Type 2 Diabetes
Publications
Daniel Peter Petrylak, Raymond P. Perez, Jingsong Zhang, David C. Smith, Joseph D. Ruether, Srikala S. Sridhar, Randeep S. Sangha, Joshua Michael Lang, Elisabeth I. Heath, Jaime R. Merchan, Elaina M. Gartner, Rong Chu, Banmeet Anand, Fernando Donate, Lynnae Jackson, Jeffrey Adams, Amal Melhem-Bertrandt, Jonathan E. Rosenberg. A phase I study of enfortumab vedotin (ASG-22CE; ASG-22ME): Updated analysis of patients with metastatic urothelial cancer. J Clin Oncol 35:15, 2017 suppl, 106-106
Jonathan E. Rosenberg, Elisabeth I. Heath, Peter J. Van Veldhuizen, Jaime R. Merchan, Joshua Michael Lang, Joseph D. Ruether, Daniel Peter Petrylak, Randeep S. Sangha, David C. Smith, Srikala S. Sridhar, Elaina M. Gartner, Martha Vincent, Rong Chu, Banmeet Anand, Fernando Donate, Lynnae Jackson, Leonard M. Reyno, and Jingsong Zhang. Anti-tumor activity, safety and pharmacokinetics (PK) of ASG-22CE (ASG-22ME; enfortumab vedotin) in a phase I dose escalation trial in patients (Pts) with metastatic urothelial cancer (mUC). J Clin Oncol 34, 2016 (suppl; abstr 4533)
Daniel Peter Petrylak, Elisabeth I. Heath, Guru Sonpavde, Saby George, Alicia Katherine Morgans, Bernhard J. Eigl, Joel Picus, Susanna Y. Cheng, Sebastien J. Hotte, Elaina M. Gartner, Martha Vincent, Rong Chu, Banmeet Anand, Karen Morrison, Lynnae Jackson, Leonard M. Reyno, Evan Y. Yu. Anti-tumor activity, safety and pharmacokinetics (PK) of AGS15E (ASG-15ME) in a phase I dose escalation trial in patients (Pts) with metastatic urothelial cancer (mUC). J Clin Oncol 34, 2016 (suppl; abstr 4532)
Wolpin BM, O'Reilly EM, Ko YJ, Blaszkowsky LS, Rarick M, Rocha-Lima CM, Ritch P, Chan E, Spratlin J, Macarulla T, McWhirter E, Pezet D, Lichinitser M, Roman L, Hartford A, Morrison K, Jackson L, Vincent M, Reyno L, Hidalgo M. Global, multicenter, randomized, phase II trial of gemcitabine and gemcitabine plus AGS-1C4D4 in patients with previously untreated, metastatic pancreatic cancer. Ann Oncol. 2013 Jul;24(7):1792-801.
DK Armstrong, PJ Sabbatini, TJ Herzog, M Vincent, LS Jackson, and L Reyno. Phase I Study of AGS-8M4, an anti-AGS-8 human antibody, in advanced Ovarian cancer. 2010 ASCO Annual Meeting Poster Presentation.
Hidalgo M., O'Reilly EM, Ko Y.J., Blaszkowsky LS, Rarick MU, Rocha Lima CMS, Ritch PS, Chan E., Spratlin JL, Macarulla T, McWhirter E, Pezet d., Lichinister M, Roman LD, Hartford A., Jackson L., Vincent M, Reyno LM, and Wolpin BM. Improved 6-Month Survival Rate in Subjects with Prostate Stem Cell Antigen Positive Tumors in a Global, Randomized Phase 2 Trial Comparing Gemcitabine vs. Gemcitabine + AGS-1C4D4 (ASP6182) in Metastatic Pancreatic Cancer. 13th World Congress on Gastrointestinal Cancer, 2011; Oral Presentation.
Wolpin BM., O'Reilly EM, Ko Y.J., Blaszkowsky LS, Rarick MU, Rocha Lima CMS, Ritch PS, Chan E., Spratlin JL, Macarulla T, McWhirter E, Pezet d., Lichinister M, Roman LD, Hartford A., Jackson L., Vincent M, Reyno LM, and Hidalgo M. Global, multicenter, open-label, randomized phase II trial comparing gemcitabine (G) with G plus AGS-1C4D4 (A) in patients (pts) with metastatic pancreatic cancer (mPC). Journal of Clinical Oncology, 2011: Vol 29, Issue 15S, page 263s.
Armstrong DK, Herzog TJ, Reyno LM, Vincent M., Jackson L., Sabbatini P. A phase I dose escalation study of AGS-8M4 (ASP6183), an anti-AGS-8 fully human antibody, in advanced ovarian cancer. Journal of Clinical Oncology, 2010. Vol 28, No. 15S, page 404s.
Hertel J., Locay H., Scarlata D., Jackson L., Prathakanti R., and Audhya P., Darbepoetin alfa administered every other week maintains hemoglobin levels over 52 weeks in patients with chronic kidney disease (CKD) converting from once-weekly recombinant human erythropoietin (rHuEPO): Results from Simplify the Treatment of Anemia with Aranesp (STAAR) study. American Journal of Nephrology, 2006; 26:149-156.
Brophy G., Sheehan V., Romig B., Voss G., Jackson L., Scarlata D., and Audhya P., Utilization patterns of erythropoiesis-stimulating proteins (ESPs) in anemic, critically ill patients admitted to the intensive care unit (ICU): interim results from the ASSESS study. Accepted as a poster presentation at the 2006 SCCM Conference in San Francisco, CA.
Brophy G., Sheehan V., Romig B., Voss G., Jackson L., Scarlata D., and Audhya P., Utilization patterns of erythropoiesis-stimulating proteins (ESPs) in anemic, critically ill patients admitted to the intensive care unit (ICU): interim results from the ASSESS study. Accepted as a poster presentation at the 2005 ASHP Conference in Las Vegas, NV.
Hertel J., Locay H., Scarlata D. and Jackson L., Darbepoetin Alfa maintains mean Hemoglobin (Hgb) levels in Chronic Kidney Disease (CKD) patients who are Erythropoietin(EPO) naïve or converting from EPO therapy. Accepted as a poster presentation at the 2004 NKF Conference in Chicago, IL.
Shikiar R., Rentz A., and Jackson L., Assessment of a Novel Method of Subcutaneous Injection in Rheumatoid Arthritis (RA) Patients: Patient Preferences at End of Trial. Accepted as an oral presentation at the 2003 ACR/AHRP Conference in Orlando, Florida.
Suranyi M., Walker R., Jackson L., Feaster J., and McDermott-Vitak A. Darbepoetin Alfa Administered Once Every Other Week Corrects Anemia in Patients with Chronic Kidney Disease (CKD). Accepted as a poster presentation at the 2001 ASN Conference in San Francisco.
Suranyi M., Walker R., Jackson L., Feaster J., and McDermott-Vitak A. Aranesp (Darbepoetin Alfa) Administered Once Every Other Week Corrects Anaemia in Patients with Early Chronic Kidney Disease (CKD). Accepted as a poster presentation at the Australia and New Zealand Society of Nephrology Conference, 2001.
Suranyi M., Jackson L., Lubina J., and McDermott A. A Novel Erythropoiesis Stimulating Protein (NESP) Administered Once Every Other Week Corrects Anemia in Patients with Chronic Renal Insufficiency (CRI). Accepted as a poster presentation at the ERA-EDTA Congress in Vienna, 2001.
Suranyi M., Jackson L., Lubina J., and McDermott A. A Novel Erythropoiesis Stimulating Protein (NESP) Administered Once Every Other Week Corrects Anemia in Patients with Chronic Renal Insufficiency (CRI). Accepted as a poster presentation at the NKF Clinical Meeting in Orlando, FL, 2001.
Lee P., Pivarnik J., Bukar J., rhIGF-I Clinical Investigators, and Jackson L. et. al.A Randomized, Placebo-Controlled Trial of combined Insulin-Like Growth Factor-I and Low-Dose Growth Hormone Therapy for Wasting Associated with HIV Infection. Journal of Clinical Endocrinology and Metabolism, 1996
Jackson L.S., Bukar J.G., Gesundheit N., and Deasy C. A Comparison of the Quality of Life of HIV Positive Patients and Healthy Controls. Poster presentation at the 10th International Conference on AIDS, 1994 in Yokohama, Japan.
Bukar J.G., Jackson L., Muro J., Jenks B.H., et. al. Effect of a Combination of Growth Hormone and rhIGF-I on the Appetite of HIV-I Positive Patients with Weight Loss. Poster presentation at the 10th International Conference on AIDS, 1994 Yokohama, Japan
Timeline
Vice President, Clinical Operations
Iambic Therapeutics, Inc.
06.2023 - 12.2023
Vice President, Clinical Operations
Pionyr Immunotherapeutics, Inc.
08.2020 - 06.2023
Sr. Clinical Consultant
Pionyr Immunotherapeutics, Inc.
10.2019 - 08.2020
Sr. Director, Clinical R & D
Agensys Inc.
10.2007 - 12.2017
Director of Project Management, Medical Affairs
Amgen Inc.
01.1996 - 10.2007
Sr. Clinical Research Associate
Genentech Inc.
03.1988 - 01.1996
Sr. Clinical Consultant
Beigene Ltd.
- 10.2019
Executive MBA -
Pepperdine University
Bachelor of Science - Biology
San Francisco State University
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