MD, Clinical Development, Infectious Diseases

Inovio Pharmaceuticals, Inc. Plymouth Meeting , PA 19462

Posted 6 days ago

Company Profile

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.

Job summary

Inovio is hiring an MD to work in our Plymouth Meeting office. This position 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. This position is a great entry point into Clinical Development in the Pharmaceutical Industry.

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 pharmaceutical experience, or similar drug development experience in an academic setting. Our preferred candidate will have experience in these areas:

  • Infectious Diseases

  • Pharmacovigilance

  • Clinical Development

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Director Clinical Compliance

Inovio Pharmaceuticals, Inc.

Posted 3 weeks ago

VIEW JOBS 2/26/2019 12:00:00 AM 2019-05-27T00:00 Company Profile Inovio is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies that transform the treatment of cancer and infectious diseases. Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. Inovio has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Roche/Genentech, ApolloBio Corporation, The Wistar Institute, University of Pennsylvania, the Parker Institute for Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com. Job summary The Associate Director Clinical Compliance is responsible for the management and execution of activities associated with the development, revision and maintenance of clinical research procedural documents, clinical research training programs, regulatory inspection readiness, and assessment and investigation of clinical research compliance issues. This role will also assist Clinical Operations and/or Clinical Quality Assurance as needed during vendor qualifications, audits, regulatory inspections, and/or oversight assessments. Essential job functions and duties * Manage and oversee development and approval of controlled documents related to clinical study processes and systems including Policies, SOPs, Work Instructions, forms and templates * Execute strategy for role-based training curriculum, GCP training and Inspection Readiness training for the Clinical organization * Conduct and/or participate in compliance assessments and/or audits including but not limited to vendor/contractor qualification assessments * Lead, manage and oversee the tracking of Serious Clinical Non-Compliance Issues (SINC), including reporting (if applicable), and ensure follow-up and closure * Participate in the review of internal audit reports, mentor Clinical Operations staff in appropriate responses, and collaborate with the Quality function(s) to assess process improvement and/or training needs and opportunities. * Execute plans with clinical teams and cross-functionally to prepare for regulatory agency inspections * Provide representation for the Clinical Compliance function in Sponsor audits and Regulatory Agency inspections, and supervise Clinical preparation room activities, as assigned * Manage, mentor and follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA) * Assist in planning, and assign and direct work; manage, develop and support Clinical Compliance staff * Travel up to 20% may be required Minimum requirements * Bachelor degree in scientific/medical/pharmaceutical discipline or equivalent is required. * 8 years pharmaceutical industry experience with at least 5 years in clinical compliance, clinical quality assurance, clinical training or related clinical operations functions. Prior experience within clinical compliance or auditing, and clinical operations is required. * Working knowledge of ICH GCP, FDA Regulations and EU Clinical Trial Directives/Regulations; thorough knowledge of the drug development process. ISO guidelines and device experience a plus. * Strong partnering and collaboration skills. Ability to work with different functional areas within the company and accomplish goals in a matrix environment. * 5+ years of line management experience, including management, development and mentoring of assigned staff members. Disclaimer Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws. A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer. Inovio Pharmaceuticals, Inc. Plymouth Meeting PA

MD, Clinical Development, Infectious Diseases

Inovio Pharmaceuticals, Inc.