Director of Clinical Operations
3 days ago
Palo Alto
Fortvita Biologics is a biopharmaceutical company based in the San Francisco Bay Area specializing in antibody discovery and engineering, with platforms that span antibody-drug conjugates (ADCs), bispecifics, and multispecifics. Our pipeline targets oncology, immunology, and neurodegenerative diseases and is supported by a team of over 100 across research, development, regulatory, and operational functions. With a global clinical presence and an emphasis on thoughtful design and agile execution, Fortvita is working to translate next-generation biologics from concept to clinic. Summary Fortvita is seeking a dynamic and experienced Director of Clinical Operations to managing CRO’s and other external vendors, collaborating with cross-functional teams, ensuring study strategy is incorporated into the execution of each study, and that studies are executed on-time, on-budget and in compliance with FDA, EMA & ICH guidelines, SOPs, local regulations. This position requires a high-performing contributor with strong business acumen and leadership skills. This individual must be able to work and lead in a small, fast-paced environment while also wearing multiple hats at any given time as the needs of the organization change and evolve. The annual base salary for this position ranges from $180,000 to $240,000. This is a hybrid onsite position located in Palo Alto, CA. The ideal candidate will possess a strong background in Clinical Operations and be able to collaborate with cross-functional teams and make strategic decisions. This role is a hybrid model. Responsibilities • Responsible for global clinical trial execution in compliance with ICH/GCP, SOP, regulatory, global and local guidelines., • Participate in the CRO selection process and negotiate master service agreements, scope of work contracts, change orders, etc., • Proactively manage trial start up activities in collaboration with CRO, including feasibility, country/site selection, site contract and budget negotiation, database and lab setup, study plans, training requirements, etc., • Work with cross-functional teams and external vendors to identify clinical trial operational risks and develop mitigation strategies to ensure quality delivery of the clinical trial to support regulatory submissions., • Manage CRO and other external partners and collaborate with internal cross functional teams to ensure operational delivery of the assigned clinical trials., • Plan and implement quality checks for multiple clinical trials (e.g., establish and review key performance indicators, metrics, and progress reports, identify barriers to timely and successful trial execution)., • Provide clinical operational input to protocol, ICF, safety and other relevant clinical trial key documents and plans., • Drive and support the development of work instructions and SOPs; contribute to Clinical Operations functional initiatives for role clarity and institution of best practices., • Support the manager to lead clinical operation activities including feasibility, country selection, regulatory and ethic submissions, site startup, operational input to the study design, risk-based quality management., • Prepare clinical trial documents, e.g., project plans, communication plans, clinical trial management plan, site selection, SIV, patient recruitment and retention plan, etc., • Effectively communicate regular clinical trial updates to management on clinical trial progress, performance, risks and mitigation strategies., • All other duties as assigned Qualifications Education: • Bachelor of Science or equivalent degree, required., • Master of Science/Advanced degree preferred. Experience: 10+ years of increasing leadership responsibilities in clinical operations in a pharmaceutical, biotech or CRO company • In-depth knowledge of clinical operations and pharmaceutical drug development process in a pharmaceutical or biotech company in the Autoimmune Therapeutic area, preferred., • Proven ability to lead a team, supervise CRO, and collaborate with cross-functional teams to deliver global clinical trials with high quality, within budget and on-time., • Thorough understanding of FDA, EMA, and HIPPAA clinical research regulatory requirements, good clinical practices, project management and data handling., • Excellent written and verbal communication skills., • Ability to work cross-functionally in a fast-paced, collaborative environment., • Strong attention to detail and problem-solving skills. Compensation and Benefits Include: • Competitive base salary, bonus, and equity for all employees, • Salary Range: $180,000- $240,000. This reflects the company’s pay scale for the role. Actual compensation may vary depending on factors such as location, skills, experience, and performance., • 401(k) retirement plan with employer matching contributions, • Comprehensive medical, dental, and vision insurance, • Generous paid time off policy, including company holidays and floating holidays Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited. We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees. Additional Legal Disclaimers Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire. Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs. Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at . We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.
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