Clinical Research Medical Affairs

James Partyka, Pharm.D.

Oncology Clinical Research Scientist and Medical Affairs Expert

Palm Springs, CA 92262 760-***-**** ***********@*****.*** LinkedIn

SUMMARY OF QUALIFICATIONS

I'm a multifaceted professional with a proven record of successes spanning the Biotechnology, Hospital and Academic Industries with over 25 years of clinical oncology research, medical affairs, pharmacy and teaching experience; knowledge in writing clinical research documents according to FDA, EMEA, ICH, OIG and ICMJE regulatory guidance; excellent critical thinking and analytical skills, as well as, excellent written and verbal skill sets, and a team player with experience managing cross functional project teams.

KEY ACCOMPLISHMENTS

Marketing Authorization Application for the approval of brentuximab vedotin with a CD-30 companion diagnostic.

Clinical research and / or medical affairs support for ASTX030, TAS-120, osemitamab, lanreotide, liposomal irinotecan, cabozantinib, CC-122, neratinib, brentuximab vedotin, TAK-441, sorafenib, motesanib, panitumumab, pegfilgrastim, filgrastim, darbepoetin alfa, palifermin, romiplostim, denosumab, and topotecan.

Global Publication Lead for sorafenib

Oncology Clinical Pharmacist Specialist and Supervisor

Founding Director of the Clinical Trials Office at H. Lee Moffitt Cancer Center

Founding Director of the ASHP accredited Oncology Pharmacy Residency at H. Lee Moffitt Cancer Center

AREAS OF EXPERTISE

Clinical trials

Hematologic CA

Solid tumors

Publications

Medical Info

Oncology MSL

Academic Teaching

Patient Care

Clinical Pharmacy

Public Speaking

Epidemiology

Biostatistics

Drug Approval Filings

Scientific Writing & Editing

RAVE / InForm experience

IRB / Data Monitoring Committees

Cross Functional Team Management

Budget Management

PROFESSIONAL EXPERIENCE

Independent Clinical Oncology Scientist, Palm Springs, CA 2004 -

Responsibilities encompass designing and executing phase I-III clinical trials to evaluate the efficacy and safety of novel oncology and immuno-oncology therapies. In addition, to analyze and interpret data, and collaborate with investigators, and ensure compliance with regulatory standards throughout the research process.

Transcenta Inc., Sr. Director, Clinical Science, Princeton, NJ 2023 - 2023

Collaborated with medical directors on GI grant submissions and IIT projects, along with study teams delivered tactical communication strategies, publications, INDs and regulatory submissions, protocols, amendments and other related supporting documents, clinical data collection and analyses, investigator communications, and developed clinical study reports for TST001 in GI malignancies.

Key Contributions:

Collaborated effectively with project and functional teams in clinical development on compound strategy and tactics, and development of product development plans. Sr. Clinical lead in cross-functional sub-team meetings in collaboration with the Medical Monitor.

•Authorship of clinical study protocols, consent forms, case report forms, grants, and ancillary documents in collaboration with the Medical Monitor and study teams.

•Review ongoing PK, PD, safety, and efficacy data in real-time and preparation of summary data tables, figures, listings, and patient profiles to monitor company-sponsored and investigator-initiated studies.

•Update and develop operational processes to improve efficiency, quality, and consistency of clinical trial management across clinical development, including generation of phase 1, 2 and 3 protocol templates, development of more efficient processes for protocol development and amendments, publication management, improved processes to optimize efficiency of subject screening and enrollment, more efficient methods for data cleaning and data analysis.

•Clinical Scientist lead for managing and conducting phase 3 data monitoring committee, steering and publication committee meetings for company sponsored clinical trials including developing charters, data slides and meeting minutes.

Ipsen Biosciences, Associate Director, Medical Affairs, Cambridge, MA 2019 to 2023

•Disseminated complex scientific information and research concepts to physician investigators and served as the face of Ipsen to centers of education and research in supporting visiting professorships, guest lecturers, and symposia workshops; delivered clinical and scientific presentations to health care professionals.

•Fostered medical and scientific information exchange from the medical community to Ipsen by providing clinical and scientific support for formulary and clinical guideline decisions.

•Participated with project teams that supported MSL strategies and tactics as delegated by MSL leadership.

•Supported thought leaders in developing concepts and writing letters of intent for investigator-initiated trials and clinical trials which supported Ipsen’s therapeutic and pipeline agents.

•Successfully identified and recommended research sites for participation in Ipsen sponsored clinical trials.

Exelixis, Executive Director, Clinical Science, Alameda, CA 2017 to 2019

Exelixis, Inc. is a genomics-based drug discovery company and the producer of Cometriq (cabozantinib), a treatment approved by the U.S. Food and Drug Administration for medullary thyroid cancer with clinical activity in several other types of metastatic cancer.

Key Contributions:

•Collaborated with medical directors on the oversight of clinical trial working groups for cabozantinib phase 2 - 3 trials for medullary thyroid CA and hepatocellular CA.

•Additional responsibilities included advisory boards, DMCs, study charters, amendments, study conduct, subject enrollment barriers, safety signaling, data queries and cleaning.

•Actively participated with senior leadership on strategies and tactics for future development plans of cabozantinib.

PHARMATIVE, Executive Director, Medical Affairs, San Francisco, CA 2016 to 2017

•Developed scientific educational and promotional materials for digital media, brochures, and publications.

•Provided scientific information exchange and communication strategies for various companies.

•Participated with project teams that supported MSL strategies and tactics as delegated by senior leadership.

PUMA BIOTECHNOLOGY, INC., Director, Clinical Science, South San Franscisco, CA 2014 to 2016

Puma Biotechnology focuses on licensing innovative drug candidates that are undergoing or have already completed initial clinical testing for the treatment of various forms of cancer and seeks to further develop drug candidates for commercial use. Clinical scientific leader of clinical study teams working closely with the clinical trial managers.

Developed clinical study concepts, supervised production of medical and scientific portions of clinical research protocols, accountable for the development and execution of a clinical development strategy for an irreversible tyrosine kinase inhibitor for the treatment of metastatic breast cancer.

Key Contributions:

•Successfully reviewed, presented, and interpreted clinical trial data.

•Wrote and reviewed clinical study reports for NDAs and regulatory submissions.

•Represented and supported projects at scientific conferences; DMC and Steering committees; moderated key meetings and advisory boards with investigators.

MILLENNIUM / Takeda, Sr. Clinical Oncology Scientist, Cambridge, MA 2010 to 2014

Takeda Oncology is the Global Oncology Business Unit of Takeda Pharmaceutical, headquartered in Cambridge, Massachusetts, on the legacy site of Millennium Pharmaceuticals. I drove the clinical development of molecules from phase 1/2 through global registration under the supervision of the Global Clinical Leads by providing clinical expertise, guidance, and leadership to various project teams; molecules included an antibody drug conjugate (ADC), a tyrosine kinase inhibitor and a hedgehog pathway inhibitor in both early and late-stage development.

Key Contributions:

•Co-Clinical lead for the Marketing Authorization Application for the successful approval of Adcetris

(brentuximab vedotin) and the submission, label, and safety working groups, clinical sub-team, and clinical trial working team members.

•Project clinician for multiple phase 1 - 4 clinical trials, author/reviewer for clinical and regulatory documents including strategic development plans, protocols, investigator brochures, briefing books, and publications.

•Delivered data analyses and interpretation of clinical study results for advisory boards and steering committees.

ONYX PHARMACEUTICALS, INC., Associate Director, Publication Lead, South San Francisco, CA 2007 to 2010

Onyx Pharmaceuticals Inc is a biopharmaceutical company that develops and markets medicines for the treatment of cancer. Hired to utilize scientific and program managerial expertise in leading the strategic, operational, and tactical plans for scientific publications pertaining to Nexavar (sorafenib) according to ICMJE guidelines; developed and managed publication steering committees; developed and maintained departmental publication policies, and SOPs.

Key Contributions:

•Developed and successfully executed the company’s publication budget and provided publication support for scientific congresses and meetings. Managed, planned, wrote, and edited scientific manuscripts, abstracts, and congressional presentations.

•Supported the writing and review of Medical Information letters and FAQs and served as a reviewer on the Legal Medical Review Committee.

•Collaborated on the accuracy review of materials developed for promotional and informational content.

SENIOR MEDICAL SCIENCE LIAISON, ONCOLOGY MEDICAL AFFAIRS, AMGEN, INC., Thousand Oaks, CA 2006 to 2007

Amgen is one of the world’s leading biotechnology companies deeply rooted in science and innovation to transform innovative ideas and discoveries into medicines for patients and serious illnesses. Promoted to senior level to manage and cultivate relationships with KOLs nationally, and regionally to increase scientific and clinical knowledge of products and the clinical pipeline. Areas of expertise included clinical research support and product commercialization support for panitumumab, Neulasta (pegfilgrastim), Neupogen (filgrastim), Aranesp (darbepoetin alfa), Kepivance (palifermin), motesanib, Nplate (romiplostim) and denosumab.

Key Contributions:

•Active participant in cross-functional task forces, substituting for the Regional Director(s) when needed and leading project initiatives throughout the organization.

•Developed and implemented a relational database to capture qualitative data pertaining to clinical trial activities within the department and co-developed department reporting tools.

•Planned and managed effective scientific meeting activities for approximately sixty medical liaisons and directors.

•Study lead for clinical development trial (s), project lead for a departmental research database and member of the Amgen MSL Study Lead Task Force.

MEDICAL SCIENCE LIAISON, ONCOLOGY MEDICAL AFFAIRS, AMGEN, INC., Thousand Oaks, CA 2002 to 2005

Brought on board to identify, develop, and maintain collaborative relationships with current and future thought leaders in NYC, NJ and Tampa, FL. Specifically, to collaborate with scientific leaders by developing clinical therapeutic concepts that supported the advancement of the science associated with Amgen’s advances in oncology protein therapeutics.

Key Contributions:

•Disseminated complex scientific information and research concepts to physician investigators and served as the face of Amgen to centers of education and research in supporting visiting professorships, guest lecturers, and symposia workshops; delivered key advisory boards and scientific presentations to health care professionals.

•Fostered medical and scientific information exchange from the medical community to Amgen by providing clinical and scientific support for formulary and clinical guideline decisions.

•Participated in project teams that supported MSL strategies and tactics as delegated by MSL leadership.

•Supported thought leaders in developing concepts and writing letters of intent for investigator-initiated trials that supported Amgen’s therapeutic agents.

•Successfully identified and nominated research sites for participation in Amgen sponsored clinical trials.

Additional Career Experience

Director, Clinical Trials Office & Clinical Research, Moffitt Cancer Center, Tampa, FL

2000

to

2002

Assistant Professor, School of Medicine, Stem cell transplantation, USF, Tampa, FL

1998

to

2000

Associate in Research and Program Manager, Division of BMT, University of South FL, Tampa, FL

1995

to

1998

T E A CHI N G E X PE R I E N C E

Assistant Professor, School of Medicine, University of South FL, Tampa, FL

1995 to 2000

Clinical Instructor, University of Florida, Gainesville FL

1990 to 2002

Clinical Instructor, Working Professional PharmD Program, University of Florida, Tampa, FL

1992 to 1995

Oncology Pharmacy Residency Director and Teacher, H. Lee Moffitt Cancer Center, Tampa, FL

1992 to 1995

V O L UNTE E R E X PE RI E N CE

American Society of Clinical Oncology

American Association of Cancer Research

H ONORS and AWARDS

Millennium- Star award (2013)

Millennium- Outstanding Team Award (2012)

Millennium- Outstanding Individual Contributor Award (2012)

Onyx Pharmaceuticals Performance Award (2010)

Onyx Pharmaceuticals Award for Excellent Work (2008)

Amgen Academy Award for Excellent Work (2006)

Amgen Academy Award for Excellent Work (2005)

Merit Scholar, College of Public Health, University of South Florida (1999)

Special Recognition Award, Moffitt Cancer Center, Tampa, FL (1998)

E D UC A T I O N and CE R TI F I C A T E S

ASHP Accredited Residency in Oncology, the University of Texas, M.D. Anderson Cancer Center, Houston, TX

Doctor of Clinical Pharmacy, University of Texas at Austin/UT Health Sciences Center at San Antonio

Bachelor of Science in Pharmacy (cum laude), University of Connecticut, College of Pharmacy, Storrs, CT

Bachelor of Arts in Chemistry, College of the Holy Cross, Worcester, MA

Board Certified Pharmacotherapy Specialist (BCPS) #293370

Florida RPh #PS 0026309

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