Head of Clinical Operations

Seattle, WA, United States

Outpace Bio is a drug development company reimagining cell function through protein design to make cells the future of medicine. We believe that cells are naturally programmed by evolution to make the wrong decisions in cancer and autoimmune disease, and curative cell therapies will only be achieved by overcoming the default biological mechanisms that limit their efficacy and safety. Led by co-founders of Lyell Immunopharma, our world-class scientific team is developing smart cell therapies that reprogram complex biological processes in ways that small molecules and biologics cannot. We use protein design and synthetic biology to engineer cells to make better decisions inside the patient and to productively engage the endogenous immune system. Our unique partnership model allows us to efficiently explore diverse cell therapy modalities and accelerates clinical validation so that we can bring curative therapies to patients. We value passion for science, innovation, collaboration, inclusion, and respect.

At Outpace Bio, we believe that the highest performing teams include people from a wide variety of backgrounds and experiences. We are committed to building an open, diverse, and inclusive culture for all employees. Recognizing that the best candidates do not always match all criteria of the job description, we encourage you to apply if you think you would be a good fit for the role and are inspired by our mission to cure disease by pushing the boundaries of biology.

Outpace has an outstanding opportunity for a Head of Clinical Operations reporting to the Chief Development Officer, this is an opportunity for an experienced Clinical Operations leader to establish clinical operations capabilities for Outpace and work within a matrix team in support of our clinical development activities. The Head of Clinical Operations is the most senior person responsible for oversight and management of the Clinical Operations function at Outpace. This role will require an ability to operate in a fast-paced, highly dynamic environment with partnerships that include both internal and external stakeholders.

The Head of Clinical Operations is accountable for overseeing the Clinical Operations department including resourcing, budgeting, organizational design and operations to support the Outpace portfolio and corporate goals. The Head of Clinical Operations will provide the strategic direction and operational implementation for the department and should ensure compliance with international guidelines, local regulations and corporate policies and procedures.

The successful candidate will build a team of full-time and consultant clinical operations professionals and will immediately assume leadership for a phase 1 clinical study with IND filing at the end of 2024. This leader of Clinical Operations will directly manage program level responsibilities, including budget, timeline, and will support efforts in the planning, execution, oversight, and reporting of trial results.

Responsibilities (may include, but are not limited to):

Leadership: Provide clinical operations leadership to establish Outpace Bio's clinical operations function, balancing resource and capability needs for new and ongoing projects to enable successful and timely progress to enrollment and data availability.

Build the Team: Lead initiative to build clinical infrastructure. Plan clinical headcount and hiring needs to meet program workload demands. Oversee management, professional development, training and performance of all Clinical Operations staff. Prior functional management experience is required (managing CTAs, CRAs, CTMs, and CPMs).

Study Execution: Demonstrated ability to drive and manage clinical trial activities: i.e. experience in all aspects of study start-up and conduct, regulatory obligations, adverse event reporting, and budgeting. Ensure that clinical trials are conducted in compliance with applicable regulatory requirements and are inspection ready.

Patient Recruitment: Lead the operational strategy and execution for identifying, recruiting, and retaining investigative sites and trial participants.

Vendor Management: Primary lead managing the Contract Research Organizations (CROs), vendors, and other third parties. Oversee clinical trial-related partners and vendors. Drive vendors to meet aggressive timelines, on budget, and hold them to account if they fall behind.

Supply Management: Oversee and work collaboratively with third-party provider/CDMO/CMC on clinical logistics.

Budget Management: In close collaboration with Finance develop the Clinical Operations aspects of program budget forecasts. Provide oversight of Clinical Operations with respect to all budgets, contracts, agreements, vendor payments and processes to conduct clinical trial programs in a cost-efficient manner.

Quality: Oversee development, implementation and training on all Clinical Operations standard operational procedures, working instructions, plans, templates and other trial related documentation. Provide oversight of clinical monitoring quality and adherence to established processes and plans in compliance with GCP.

Risk Management: Proactively identify potential risks and develop and implement action plans to avoid or mitigate program risks and make appropriate trade-offs of balancing risks with study deliverables, timelines and costs.

Professional Attributes: Build strong, collaborative, and dynamic relationships with co-workers of diverse backgrounds and expertise; ability to function at a high level in a team setting whether leading the group or acting as an individual contributor. Work closely with across matrix organization including Clinical Development, CMC, Regulatory Affairs, Quality Assurance, Program Management, and other functional areas to advance pipeline and effectively execute trials in the Clinical Development Plan.

Willingness to travel for internal corporate and external investigator and scientific meetings, both nationally and internationally. Travel estimated at 15%. Comfortable working in a virtual team with schedule flexibility to build and maintain relationships across time zones (US-focus).

Values-based leadership consistent with company's core values.

Other duties as assigned.

Qualifications-Required: Bachelor's degree in the life sciences or related discipline.

15 or more years Clinical Operations experience with at least 10 years of study sponsor experience.

10 or more years of line management experience required.

Proven career track record of successful clinical trial execution with prior experience in a start-up company/limited resource environment.

Experience in early-stage oncology trials.

Experience with autologous cell therapy trials.

Experience establishing GCP processes.

Excellent team player; willingness and ability to fill functional gaps in a small organization.

Well organized, excellent written and verbal communication skills are required.

Excellent organizational skills, ability to manage multiple tasks in a fast-paced small company environment and able to adjust workload based upon changing priorities.

Experience managing CROs and vendors (or having worked within a CRO) throughout entire clinical operations life cycle.

Excellent communication skills and ability to compellingly articulate the Company's clinical and regulatory strategies to a wide audience including the CEO, the Board of Directors, Leadership Team, Company employees, therapeutic area leaders and the investor community.

Ability to travel domestically and internationally.

Qualifications-Preferred: Clinical quality assurance experience; prior audit readiness and demonstrated success through favorable audit completion.

Early-stage cell therapy oncology trial experience in small company environment.

Experience with mixed resourcing model for establishing core functional capabilities (in-house and outsourced activities).

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$220,000 - $260,000 a year

Full Time Employees (and their eligible dependents) may enroll in Outpace's medical, dental, vision, life insurance, disability, flexible spending account, and 401k plan. In addition, employees may receive stock option grants to be outlined in their offer of employment. Outpace employees enjoy flexible PTO, paid sick leave which complies with local requirements, and twelve paid holidays throughout the calendar year. Outpace also offers a generous paid parental leave policy to all regular full-time employees.

Outpace Bio is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

Applicants must be authorized to work in the United States. If you are legally authorized to work in the United States now, or in the future without any form of sponsorship, we encourage you to apply.

To protect the safety of our employees, Outpace Bio requires all new hires to submit proof of full vaccination (per CDC guidelines) from the COVID-19 virus before commencing employment. Employees can submit requests for medical or religious exemption so that Outpace Bio can consider possible accommodations. An accommodation request must be submitted at the time an offer is extended.

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