Senior Director, Clinical Development

About INOVIO

INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and human papilloma virus (HPV) diseases. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response. Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency (DARPA)/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)/Department of Defense (DOD), GeneOne Life Science/VGXI, HIV Vaccines Trial Network, International Vaccine Institute (IVI), Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Roche/Genentech, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. For more information, visit www.inovio.com.

Job summary

The primary role of the Senior Director, Clinical Development is to provide clinical and medical expertise to advance INOVIO’s oncology pipeline. S/he is a key member of the senior staff and contributes to the clinical strategy and execution of clinical oncology programs.  The Senior Director, Clinical Development partners with the Senior Vice President, Clinical Development to provide medical monitoring, strategic input, and overall clinical trial leadership and support, while collaborating with colleagues in Clinical, R&D, Regulatory, Commercial, Biostatistics, and Epidemiology as well external partners including contract research organizations (CROs), principal investigators, clinical site personnel, key opinion leaders and funding agencies.

Success in this role requires self-motivation, creativity, integrative thinking, and a strong work ethic.  The candidate is expected to thrive in a dynamic, changing environment of biotechnology. 

Essential job functions and duties

The Senior Director, Clinical Development will lead the medical and clinical input to the cross-functional team and is accountable for the scientific content of all study design and data interpretation activities and deliverables, including clinical content of protocols and clinical study reports and publications.  In addition, s/he will participate in program and study planning, and governance interactions such as investment decisions for planned and ongoing studies in oncology.  The candidate who fills this position may be located anywhere in the continental United States.

Accountable for safety across the study:

• Provide leadership for medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site, and patient level.
• Lead development of and adherence to safety review. Perform and document regular review of individual subject safety data and cumulative safety data. 
• Monitor study safety issues and provide input to serious adverse events (SAEs) reports.
• Participate in Safety Review to evaluate medical benefits/risks to support targeted clinical indications.
• Review literature as needed to respond to safety questions.
• Communicate safety information to sites across the study and provide responses to questions on safety.

Develop protocol design and strategy:

• Provide medical leadership during development and updates to the clinical development plan.
• Design clinical studies to meet the stated objectives. Ensure clinical trial objectives fit with the clinical program strategy.
• Review and ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and has been reviewed by IRB/IECs.
• Provide medical input into site and country feasibility.

Provide support to study team:

• Provide medical monitoring of clinical trials, with focus on subject eligibility, safety assessments, and data integrity.
• Provide clinical input to protocol / study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, and data quality planning as needed.
• Develop and maintain peer-to-peer relationships with healthcare professionals at clinical trial sites.
• Advise and Contribute to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines, including ensuring medical/technical requirements for data integrity are applied.
• Work with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments as study is ongoing.
• Conduct medical review and interpretation of efficacy and safety data from clinical trials, including 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).
• Provide 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.
• Participate with Data Monitoring Committees and Steering Committees as required.
• Coordinate 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, and inspection readiness.

Provide support to program team:

• Author clinical sections of regulatory documents (e.g. Investigator Brochure, Annual Reports, Investigational New Drug sections, Clinical Study Reports).
• Co-author abstracts, posters, presentations and publications.
• Act as clinical leader in in-licensing activities such as due diligence reviews and reports.
• Interface with discovery, safety sciences, statistics, clinical pharmacology, commercial, regulatory, outcomes research, development operations and other members of the extended project team(s).
• Execute on-time and within-budget 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.

Minimum requirements

• M.D./ D, O. Degree Board certified/board eligible highly preferred.  Would consider Ph.D. with relevant experience.
• Must have clinical development and medical monitor experience in the biotech/pharmaceutical arena with a minimum of three years.
• Experience in pre-cancer and/or oncology, vaccines, pharmacovigilance, and clinical development.

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, gender identity and expression, religion, marital status, registered domestic partner status, age, national origin or ancestry, military or 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. 

Important notice to employment businesses/agencies

INOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore INOVIO will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at INOVIO.