VP, Clinical Operations
Vice President, Clinical Operations
Antiva Biosciences, Inc. is a privately held San Francisco Bay Area-based biopharmaceutical company focused on the development of antiviral therapies. The company is using a new medicinal chemistry platform to develop antiviral therapies, focusing first on HPV. Antiva has additional molecules that target HIV, the herpes virus, cytomegalovirus and others. Antiva’s lead compound, ABI-1968 is a topical antiviral for the treatment of human papillomavirus (HPV) infections, the primary cause of cervical and anal cancer. We are seeking a VP, Clinical Operations, reporting to the CMO, who will have responsibility for developing and implementing the strategies required to successfully implement and execute Antiva’s clinical studies.
Specific Responsibilities include (but not limited to):
- Lead clinical operations strategic planning activities and translate strategic decisions into actionable operational plans.
- Identify the resource needs for implementation of operational plans and develop a resource-tracking process; partner with head of project management to incorporate and update clinical timeline and budget into overall product development plans
- Provide strategic planning and feasibility analysis for site selection, contract negotiations and patient recruitment programs.
- Manage clinical trial implementation with clinical sites, external consultants and CRO personnel to ensure timely implementation of clinical studies in accordance with GCP regulatory requirements.
- Interact with investigators as warranted to obtain necessary documentation and information before, during and after the study.
- Prepare and present at investigator meetings to ensure that the clinical and investigational site staff team is well informed about the study and related procedures.
- With CRO partner, manage investigator recruitment activities including identification and contacting of potential investigators; conduct pre-study site visits to assess the willingness and suitability of potential clinical sites.
- Manage the maintenance of regulatory documentation from clinical sites and investigators required for the initiation and continuation of clinical studies; manage patient accrual, screening and enrollment information from sites.
- Oversee the operational selection of various vendors and the review of proposal requests.
- Work with various in-house functional group leads and external advisors with regards to clinical study operational issues including safety reporting and processing, study drug supply plans, cross-functional communication/interaction plan and monitoring.
- Manage progress of clinical studies and ensure adherence to the protocol, timelines, and budget. This includes reviewing site recruitment, initiation and patient enrollment progress and reviewing and acting on trending reports.
- Partner and liaise with Project Management, Biometrics, Regulatory and CMC to ensure that clinical trials are managed within timelines and budget guidelines.
- Develop and manage clinical trial budgets; proactively provide senior management with necessary updates on progress and changes in scope, schedule, and resources in a timely manner.
- Collaborate with the CMO to generate high quality clinical study reports, investigator brochures, clinical protocols, publications and presentations of clinical study results.
- Prepare, coordinate and maintain clinical sections for regulatory submissions.
- Prepare and deliver effective presentations to the Project Team, Senior Management and external parties.
- Position requires a Bachelor of Science degree and at least 15 years pharmaceutical industry experience specifically in human drug development. Position also requires at least 10 years of experience in the clinical development & management of clinical operation function.
- Experience participating in international clinical studies required.
- Experience working in a small startup setting is a ‘must have
- Higher degree (i.e. PhD, PharmD, MPH, MBA, etc) is desirable. Therapeutic area experience in Women’s health and/or HIV medicine is highly desirable.
- Clinical trial experience with topical products is a plus. Strong understanding of CFR and ICH guidelines, regulations and guidelines governing conduct of clinical studies, clinical protocols, investigator brochures and other materials.
- Excellent verbal and written communication and presentation skills. Excellent leadership and interpersonal skills with an ability to effectively work within a multidisciplinary team, provide mentorship to team members and to effectively manage multiple vendors.
- Ability to efficiently manage direct and indirect reports including remote staff.
- Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines.
- Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves and multi-task in order to thrive in small company environment.
- Ability to proactively identify challenges, possess strategic foresight and implement appropriate courses of action
- Proven track record of successfully delivering projects on time, to budget and at the required quality.
- Demonstrated ability to effectively negotiate contracts and financial terms.
- Successful track record in managing Phase I and, Phase II global clinical trials.
- Experience leading pivotal studies is a plus. Willingness to travel as necessary, consistent with study needs.
Antiva provides comprehensive and competitive benefit and compensation plans as well as a collegial, collaborative culture committed to improving health outcomes for individuals with HPV related viruses.
Qualified candidates may submit their resume to firstname.lastname@example.org