Director Clinical Operations (On-site/hybrid)

Neomorph•San Diego, CA

1d•Hybrid

About The Position

The Director of Clinical Operations is responsible for strategic leadership and oversight of the company’s clinical trial portfolio to ensure programs are executed in accordance with protocols, regulatory requirements, ICH-GCP guidelines, and company SOPs. This role reports to the VP of Clinical Operations and partners closely with Clinical Development and senior cross‑functional leaders to drive high‑quality, timely, and cost-effective clinical trial delivery that supports the company’s development and registration strategy. The Director will provide strategic direction to internal clinical operations staff and external partners, oversee CRO and vendor performance, and play a key role in shaping and scaling the Clinical Operations function as the company grows. This is a hybrid position based at our San Diego site.

Requirements

Bachelor’s degree in life sciences, nursing, public health, or related field required.
Minimum of 10 years of experience in clinical research/clinical operations within biotech, pharma, or CRO environments, with increasing leadership responsibility.
Proven track record overseeing Phase I–III global clinical trials, including extensive experience with early-phase (Phase 1) studies and first‑in‑human trials.
Extensive experience managing CROs and external vendors, including selection, contracting, and ongoing performance oversight.
Demonstrated success leading clinical operations in a small biotech or start‑up setting, balancing strategic leadership with hands‑on execution.
Experience collaborating with internal or external CMC partners to ensure clinical trial supply readiness and effective supply chain management.
Strong understanding of global regulatory requirements, GCP guidelines, and end-to-end clinical trial operations.
Experience contributing to and maintaining clinical databases and electronic systems to support clinical programs (e.g., EDC, CTMS, IRT).
Deep understanding of clinical trial costs, budgeting, and accounting principles, with experience managing multi‑million‑dollar study or program budgets.
Strong project and portfolio management skills, with the ability to manage multiple studies/programs and competing priorities in a fast-paced environment.
Demonstrated leadership, people management, and mentoring skills, with a collaborative and solutions-oriented approach.
Excellent verbal and written communication skills, with the ability to influence and drive alignment across internal teams and external partners.

Nice To Haves

Advanced degree (MS, MPH, PharmD, or PhD) preferred.

Responsibilities

Provide strategic oversight of clinical operations across one or more programs, from first-in-human through late-stage development.
Translate clinical development plans into operational strategies, including scenario planning, timelines, and resourcing for assigned programs.
Lead integrated operational planning for studies, ensuring alignment across clinical, regulatory, biometrics, safety, and CMC functions.
Identify program- and study-level risks and interdependencies, and implement proactive mitigation strategies to maintain program and study timelines.
Oversee the end-to-end operational management of clinical trials from start-up through close-out, ensuring delivery on time, within budget, and with high data quality.
Ensure robust study plans, timelines, and tracking tools are in place and utilized to monitor progress and performance across trials.
Provide leadership and guidance to team members responsible for day-to-day trial execution, ensuring operational excellence and compliance.
Lead the strategic and operational oversight of CROs, clinical vendors, and consultants at the program and study level, ensuring accountability for timelines, quality, and budget adherence.
Drive vendor selection, RFP processes, scope definition, and contract negotiations in partnership with Clinical Operations leadership, Legal, and Finance.
Establish and monitor performance metrics (KPIs) for CROs and key vendors, and participate in both governance and routine meetings to review performance and address issues.
Oversee site strategy across a given program, including site selection, activation, enrollment, and retention plans, in collaboration with CRO partners.
Review aggregate site and monitoring metrics (enrollment, data quality, query rates, protocol deviations) and drive corrective and preventive actions as needed.
Ensure Sponsor oversight of clinical study site and monitoring activities.
Champion and execute on site and investigator engagement strategies to optimize enrollment, patient experience, and site relationships.
Provide strategic input into study start-up plans, including feasibility, country and site selection, and regulatory submission strategies.
Provide operational oversight during study start-up ensuring study site and CRO alignment with Sponsor requirements, including review of clinical trial agreements, budgets, and informed consent forms.
Oversee regulatory vendors to ensure completion of maintenance submissions, ensuring high-quality operational input into key documents and health authority responses.
Ensure inspection-readiness of programs and studies through robust documentation, training, and quality oversight.
Own or co-own clinical operations budgets at the program and/or study level, including forecasting, accruals, and scenario planning.
Oversee review and approval of CRO and vendor budgets, SOWs, and change orders to ensure alignment with operational plans and contracts.
Oversee review and approval of study site budgets and amendments to ensure alignment with operational plans.
Monitor clinical trial expenditures, identify variances, and implement plans to keep programs within budget while maintaining quality and timelines.
Ensure that all clinical trials are conducted in full compliance with ICH-GCP, global regulatory requirements, and company SOPs.
Partner with Quality Assurance to support audits and inspections and lead resolution of clinical operations findings and CAPAs.
Contribute to clinical quality activities, including SOP writing and review, and audit planning.
Embed a culture of quality, patient safety, and continuous improvement within the clinical operations team and with external partners.
Provide leadership, coaching, and mentorship to clinical operations staff; may directly manage Clinical Trial Managers and/or Clinical Research Associates.
Contribute to organizational design, hiring, onboarding, and development of the clinical operations team as the company scales.
Develop and refine clinical operations processes, tools, and SOPs to support efficient, scalable execution in a fast-paced biotech environment.
Partner closely with Clinical Development, Regulatory, Pharmacovigilance, Biometrics, CMC, and other stakeholders to ensure alignment and seamless execution.
Represent Clinical Operations in cross-functional program teams and governance forums, presenting operational strategies, risks, and status updates to senior leadership.
Communicate effectively across all levels of the organization, ensuring transparency around program progress, challenges, and mitigation plans.

Benefits

Industry-competitive compensation
Annual target bonus
Stock options
401K plan
Career advancement opportunities
Monthly town halls to share business and scientific updates
Comprehensive medical, dental, and vision plans for employees and their dependents
Health and Dependent Care FSA and HSA Plan with a monthly Neomorph contribution
Employee Assistance Program
10 holidays + Winter Shutdown + 3 weeks of vacation time with additional accruals after 2nd year of employment, separate sick leave.
Supplemental pay for Pregnancy Disability Leave
Paid Parental Leave for employees with a newborn child or a child placed with them for adoption or foster care
Lifestyle Casual work environment
Volunteer days off each year to spend time contributing to causes you care about
Flexible work schedule
Access to a state-of-the-art gym
On-site space to store your bicycle (or surfboard)