Inovio Pharmaceuticals, Inc. Plymouth Meeting , PA 19462
Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that 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, Genentech, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life Sciences, ApolloBio Corporation, 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.
The Associate Director Clinical Compliance is responsible for the management and execution of activities associated with clinical procedural development and maintenance, clinical training programs, inspection preparedness, and assessment and investigation of clinical quality compliance issues. This position is also responsible for management and execution of clinical vendor qualification 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
Oversee and/or conduct compliance assessments including but not limited to vendor/contractor qualification assessments
Manage and oversee the tracking of Suspected Serious Clinical Non-Compliance Issues (SSCNCI), including reporting (if applicable) and ensure follow-up and closure
Manage the review of internal audit reports 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 audits and regulatory agency inspections
Provide representation for the Clinical Compliance function in Sponsor audits and Regulatory Agency inspections, and supervise Clinical preparation room activities
Manage follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)
Plan, assign and direct work; manage, develop and support Clinical Compliance staff
Travel up to 20% may be required
Bachelor degree in scientific/medical/pharmaceutical discipline or equivalent is required.
8 years pharmaceutical industry experience with at least 5 years in compliance, quality, training or related clinical operations function. Prior experience with both clinical auditing and operations is required.
Working knowledge of ICH GCP, FDA Regulations and EU Clinical Trial Directives; 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.
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, 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.