$200K — $250K *
The Director of Clinical Operations will work closely with the VP (Clinical Affairs & Pharmacovigilance) and will provide project management and oversight of conduct of Evofem clinical trials in accordance with ICH GCP regulations, maintaining compliance and supporting regulatory authority submissions. Job Responsibilities: These may include but are not limited to: • Direct and oversee the operation of the clinical program(s) to ensure compliance with regulatory requirements. • Ensure adequacy of data acquisition and management, and timely completion of studies and associated projects. • Identify and communicate project objectives, propose innovative solutions to potential obstacles in study conduct, study sites, or with CROs. • Ensure adequate study resources are in place to successfully complete clinical project and programs on-time and, on-budget. • Evaluate CROs for their ability to execute clinical trial work, compare budgets and timelines and make recommendations to senior management. • Coordinate with departmental teams to ensure appropriate fiscal oversight, including management of vendor scopes-of-work and change orders. • Oversees the operational aspects for the development and delivery of standard study protocols, informed consents, vendor selection/management and site selection and recruitment strategies. • Oversee vendor and site qualification activities in conjunction with Clinical Quality Assurance, Manufacturing and Tech operations. • Oversee management and maintenance of Trial Master File. • Support regulatory audits and inspections. • Provide guidance on all clinical operation logistics associated with execution of clinical studies (including clinical supplies, sample shipments etc.). • May contribute to the development of SOPs and other procedural documents. Competencies: • Must have excellent accountability, facilitation, organizational, analytical, and time management skills. • Experience considered relevant includes clinical or basic research in Biotech, Pharmaceutical or Contract Research Organization. • In-depth experience with drug development issues. • A good understanding of GLPs, GCPs, and ICH Guidelines. • Must be detailed oriented, possess excellent time management skills, be well organized, and display a professional demeanor with a high focus on quality, compliance, and responsibilities. • Must be able to work as a team member, multi-task, and maintain day-to-day activities while being responsive to changing priorities. • Must possess excellent communication and technical writing skills, strong interpersonal skills, and ability to work with others positively and collaboratively; able to communicate with a sense of urgency to internal and external customers. Supervisory Responsibility: • This position may manage internal and external representatives. Education and Qualifications: • Advanced scientific degree a plus (MS in biological sciences, Pharm D or related discipline) with at least 10 years’ experience working in the biotechnology/pharmaceutical industry (an equivalent combination of experience and education may be considered). • Prior experience managing third parties and external service providers (worldwide) and consultants. • Excellent writing skills as they relate to the preparation of clinical and regulatory documents. • Excellent interpersonal skills with strong oral/written communication and presentation skills. • Excellent negotiation skills and a tactful approach that leads to high value on services obtained and outcomes achieved. • Demonstration of cross-functional understanding related to drug development. • Good judge of risks and a keen ability to analyze options and manage outcomes. • Familiarity of Regulatory Affairs as applicable to clinical data and report filings. • Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity. • Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel. Travel: • Ability to travel 10-20% domestic.
Valid through: 11/4/2020