Geoffrey Cox, PharmD
Lansdale
Summary
Experienced oncology clinical development pharmaceutical professional, driven to bring medicines to patients. Seeking a scientifically focused role to further my career in improving patients' lives. Drove the development of small molecule and biologic global medicine teams to deliver Phase 1-4 studies, such as elranatamab and palbociclib, in solid tumors (i.e. Lung and Breast cancer) and hematologic malignancies (i.e. AML, multiple myeloma). Accelerated successful submissions of glasdegib and lorlatinib for marketing authorization years ahead of schedule. Experienced in medical writing, clinical efficacy/safety data analysis, protocol/informed consent development and submission summary document creation. Strong ability to take an existing deliverable (i.e., a protocol) and extrapolate what is needed to create a new deliverable. Highly skilled at problem-solving, literature research and matrix team management. Recently supported Oncology Clinical Development group by performing safety signal detection, amending protocols, leading independent data monitoring committee meeting preparation and protocol deviation analysis and review.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Clinical Scientist
Immunocore
Conshohocken
04.2024 - Current
- Consulted in the preparation of regulatory documents including investigator brochures and informed consent forms.
- Provided scientific support to investigative sites regarding subject eligibility, protocol interpretation and dosing management.
- Reviewed serious adverse event reports, ensured proper documentation according to FDA regulations, and queried data when discrepancies were identified.
- Evaluated clinical trial safety data from multiple sources to assess the safety profile of investigational products.
- Acted as an unblinded RECIST efficacy reviewer for a pivotal clinical trial.
- Analyzed clinical data for accuracy and consistency throughout the study lifecycle.
Associate Director/Director Asset Planner
Pfizer
06.2014 - Current
- Leveraged technical and clinical development expertise to deliver early and late-stage protocol development on cost and exceeding aggressive timelines.
- Directed Clinician Science and Clinical Pharmacology groups to develop PMARs and efficacy/safety Summary documents to support NDA/BLA and SNDA/SBLA submissions.
- Led refinement of Oncology resource management process including building reports and developing annual algorithm update process for Senior Functional Leadership including Clinical Science and Clinical Pharmacology, increasing resourcing efficiency.
- Delivered scenario planning including modeling cost and resource forecasting in support of life cycle management to enable senior leadership decision-making.
- Mentored colleagues and formally shared subject matter expertise to raise the level of project planning, providing internal and external recognition of the excellence of our project management group.
- Oncology Clinical Development
Clinical Pharmacist
Creighton University Pharmacy Rotations
06.2021 - 04.2022
- Performed patient therapy monitoring to ensure comprehensive, effective treatment.
- Analyzed clinical efficacy and safety data to support empiric therapy management decision-making.
- Supported patient care teams by acting as the pharmacy point of contact for medication-related issues, such as dosing adjustments, safety profiles, and drug-drug interaction screenings.
- Collaborated with healthcare teams to optimize drug therapy plans.
Industry Clinical Pharmacologist
Creighton Pharmacy School Rotation at Pfizer
09.2021 - 11.2021
- Performed quantitative model-based analysis of patient clinical trial data to interrogate dose-response relationships for safety and efficacy variables.
- Supported ongoing initiatives to incorporate the use of prospective modeling of oncology endpoints to aid in medicine development.
- Gained hands-on experience with model-based drug metabolism and pharmacokinetic data management and analysis.
Associate Director Project Manager
Pfizer
06.2010 - 06.2014
- Guided Teams through a multitude of Governance interactions and processes to ensure efficient interactions, lead production of concise and impactful presentations and managed Governance feedback and actions to improve development strategy and operations.
- Provided comprehensive project management leadership for multiple international oncology cross functional teams concurrently to ensure execution of constantly evolving strategic and operational objectives.
- Managed program scope to optimize resource utilization and maximize portfolio value.
- Supervised internal safety data monitoring committee reviewing blinded AE data and analyzing discrepancies leading to increased efficiency of drug development and decreased time to product launch for multiple blockbuster medicines.
- Oncology Clinical Development
Education
PharmD D -
Creighton University
05.2022
Master Of Arts - Biology
Brown University
Bachelor Of Science - Chemistry
University Of Richmond
Skills
- Protocol Deviation Management
- Clinical Data Analysis
- Oncology Clinical Development
- Clinical Trial Design
- Query Management
- Literature research
- Health Authority Submissions
- Problem Solving
- Project Management
- Project Risk Management
- Protocol Development
- Protocol Deviation Review
- Data Cleaning
- Dosing Schedule Management
- CRO management
Certification
PMP, Project Management Institute
Timeline
Clinical Scientist
Immunocore
04.2024 - Current
Industry Clinical Pharmacologist
Creighton Pharmacy School Rotation at Pfizer
09.2021 - 11.2021
Clinical Pharmacist
Creighton University Pharmacy Rotations
06.2021 - 04.2022
Associate Director/Director Asset Planner
Pfizer
06.2014 - Current
Associate Director Project Manager
Pfizer
06.2010 - 06.2014
PharmD D -
Creighton University
Master Of Arts - Biology
Brown University
Bachelor Of Science - Chemistry
University Of Richmond