Inovio Pharmaceuticals Director of Clinical Development (MD), Oncology Clinical Development - Plymouth Meeting, PA - Full Time
Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. The company is advancing a growing clinical and preclinical stage product pipeline. Partners and collaborators include MedImmune, Roche, University of Pennsylvania, DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.
Inovio is hiring a Director, Clinical Development Oncology to work in our Plymouth Meeting office. The Director provides strategic contribution and support for Inovio Pharmaceuticals while collaborating with respective Commercial, Biostatistics, Epidemiology, and Clinical colleagues in the development and implementation of components of an External Engagement, Data Generation and Lifecycle program for multiple assets.
These are the primary areas of responsibility:
Accountable for safety across the study:
Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level.
Ensures development of and adherence to safety review. Performs and documents regular review of individual subject safety data, and performs review of cumulative safety data.
Monitor study safety issues and provide input to serious adverse events (SAEs) reports.
Participates in Safety Review to evaluate medical benefits/risks to support targeted clinical indications.
Reviews literature as needed to respond to safety questions.
Communicates safety information to sites across the study and provides responses to questions on safety.
Protocol design and strategy:
Provide medical input during development and updates to the clinical development plan.
Designs clinical studies to meet the stated objectives. Assures that clinical trial objectives fit with the clinical program strategy.
Ensure that documents (protocol, Informed Consent Document [ICD], etc) meet regulatory requirements and company policy and has been reviewed by IRB/IECs.
Provides medical input into country feasibility.
Support study team
Provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed.
Develop and maintain peer to peer relationships with healthcare professionals at clinical trial sites.
Contributes to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied.
Works with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.
Conducts medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer; accountable for overall quality and timeliness of analysis and reporting.
Responsible for medical and scientific validity of study report, especially conclusions regarding efficacy and safety. Responsible for disclosure of appropriate safety and efficacy data and conclusions (e.g. ClinicalTrials.gov, EudraCT.).
Provides protocol specific training to study team, investigators, clinical research associate, and others.
Interact with healthcare professionals at sites during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level.
Interacts with Data Monitoring Committees and Steering Committees as required.
Coordinates medical opinions with other physicians globally to ensure consistency.
Notify appropriate study team personnel of the need to inform investigators of any changes in research activity and any significant new adverse events.
Monitor investigator compliance with protocol and regulatory requirements.
Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc.
Supports the program team:
Authors clinical sections of regulatory documents (e.g. Investigator Brochure, Annual Reports, Investigational New Drug sections, Clinical Study Reports).
May co-author abstracts, posters, presentations and publications.
Acts as clinical representative in in-licensing activities such as due diligence reviews and reports.
As a key member of the Program team, interfaces with discovery, safety sciences, statistics, clinical pharmacology, commercial, regulatory, outcomes research, Development Operations and other members of the extended project team(s).
Responsible for the on-time and within-budget execution of protocols.
Interact with regulatory authorities, key opinion leaders, and principal investigators:
Support Regulatory Authority interactions accountable for providing responses.
Liaise with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders /Principal Investigators network for new trials.
The preferred candidate has the following education and experience :
MD with at least 3 years pharmaceutical experience and familiarity with:
- Clinical Development
- Working with KOLs and advisory boards
- Challenging the status quo and asking probing questions
- Timely project execution