Director Clinical Operations

Director Clinical Operations

San Francisco Bay Area (Remote, but must be based in SF area to go to office 1 time per month)

Compensation : $220,000-2500,000 Bonus Equity

Company Summary :

We are partnered with an innovative ADC-focused biotech experiencing significant growth this year. Their unique approach utilizes previously inaccessible targeting molecules positioning them as a leader in ADC development. They have two lead programs in Phase 1 targeting high-need solid tumors, with promising preclinical results. The leadership team is highly experienced, with the CMO having brought three novel drugs to market. They raised over $100 million in their series B last year and secured deals with major pharmaceutical companies worth over $1 billion. They are seeking a Clinical Operations Leader to run their early phase studies.

Primary Responsibilities :

• Provide strategic leadership and direction to study teams, ensuring the planning and execution of clinical trials meet timelines and quality deliverables in line with corporate study goals.
• Oversee global harmonization of study processes and CRO / vendor activities, ensuring transparency and consistency across Clinical Trial Leads and the study execution team.
• Independently manage and oversee budgets and timelines, reporting and justifying study metrics to product teams and executive management; participate in financial forecasting, accruals, and reconciliations.
• Establish and / or implement best trial management practices, standards, systems, and SOPs in collaboration with other members of the clinical operations and cross-functional teams.
• Ensure clinical trials are conducted in compliance with the protocol and applicable regulatory requirements, and oversee / drive / collaborate on inspection readiness activities.
• Contribute to the development of protocols, Investigator Brochures, DSURs, and clinical study reports; oversee the creation of project plans, study manuals, and trial tools.
• Present Clinical Operations strategy and updates to program teams, senior leadership, and executive committee.
• Establish strong relationships, working in partnership with key stakeholders.
• Seek alignment within the organization to maximize the delivery of outputs and achieve the overall clinical operations strategy.
• Bring a "can-do" attitude while respectfully challenging partners and being assertive when necessary with project timelines, finances, and scope; stretch Clinical Operations and other clinical departments to deliver more, while also serving as a gatekeeper for new initiatives and studies regarding feasibility, regulatory issues, and prioritization within overall budget and resource constraints.
• Directly lead, coach, and mentor Clinical Operations staff : Ensure the recruitment and development of the right talent and therapeutic area expertise to enable the appropriate level of strategic input into clinical program design and clinical study design. Responsible for the growth and development of talent.
• Continually raise the bar for the operationalization of oncology study teams, driving timeline and resource efficiency, and ensuring information is captured, retained, and shared across functions to leverage in future work.
• Develop and implement strategic CRO and vendor selection and provide management and documented oversight; accountable for resolving vendor issues that need to be addressed at the executive level.

Ideal Qualifications :

Salary : $220,000 - $2,500,000