Autonomybio
Head of Operations / COO
San Francisco Office · Exec
Sponsorship not specifiedDetected 474 days ago
ComplianceProject ManagementOKRsFinancial ModelingFinancial AnalysisSupply ChainProcess ImprovementFDA RegulatoryLeadershipCommunicationPublic SpeakingFinancial ReportingGxP
About the role
- This is a new paradigm focused on keeping healthy people healthy as opposed to treating individual diseases after they occur.
- Read more in our Candidate Guide https://strong-transport-ceb.notion.site/Candidate-Guide-1a01fc245011803fbc7becb61ea1d52c?pvs=4.
- Provide ongoing financial reporting and scenario planning to inform executive decisions.
Requirements
- Familiarity with drug development timelines, especially for combination products requiring scale-up in CMC, regulatory, and clinical frameworks.
Nice to have
- 3+ years of Executive or Senior Operational Experience in biotech, pharma, or a related industry.
- Demonstrable Success Overseeing Phase Transitions (e.g., from early-stage to late-stage clinical) and coordinating cross-functional teams.
- Proven Track Record of Establishing Quality Systems (GxP, QMS) and scaling manufacturing processes (especially for combination products).
- Experience Scaling and Managing Teams of 5-20+ Members with direct accountability for their performance.
- Startup Experience (2+ years) or similar environment where agility and hands-on leadership are paramount.
- Bachelor's degree in Life Sciences, Engineering, Business, or related field (advanced degree preferred).
Skills
- Implemented OKRs and Scorecards that allow for real-time reporting on departmental projects.
- Hired 3-5 Key FTEs using a well-structured interview and evaluation process.
- Completed Robust Financial & Resource Planning for at least the next 12-18 months, covering departmental budgets and spending forecasts.
- Scaled the Organization from a handful of FTEs to potentially 15-25+ FTEs, with clear departmental structures.
- Fully Operationalized Compliance Systems (QMS, HR, GxP frameworks) to meet the unique demands of combination-product development.
- Established a Physical Office, along with robust operational infrastructure (finance software, data management platforms, etc.).
- Implemented a Globally Recognized Quality Management System (QMS) that addresses all combination-product regulatory requirements.
- Able to incorporate modern tools (project management software, data dashboards, AI-driven workflows) to streamline operations.
Benefits
- Own the operational details that make our bold vision a reality.
Company info
- We are an early-stage biotech company developing drugs with the goal of reducing multi-morbidity and earning an indication for aging, as opposed to the treatment of specific diseases. Our ultimate mission is to establish aging as a therapeutic area and empower humans with more time with loved ones and autonomy over their health. This is a new paradigm focused on keeping healthy people healthy as opposed to treating individual diseases after they occur.
- As our Head of Operations / Chief Operating Officer, you'll be orchestrating the people, processes, and culture needed to bring our mission to life.
- We are an early-stage biotech company developing drugs with the goal of reducing multi-morbidity and earning an indication for aging, as opposed to the treatment of specific diseases.
- Our ultimate mission is to establish aging as a therapeutic area and empower humans with more time with loved ones and autonomy over their health.
- Here's how you'll help us shape the future of aging therapeutics:
- Departmental Accountability & Integration: Develop and refine processes (OKRs, project management frameworks) that streamline cross-departmental collaborations and decision-making.
- Organizational Culture & Process Optimization: Foster a collaborative, and results-driven culture consistent with our core values (Ownership, Hacker Mindset, Rigor, Communication, Care).
- Hiring & Team Development: Oversee strategic hiring plans, ensuring we attract and retain top talent.
- Champion Day-to-Day Excellence: Own the operational details that make our bold vision a reality. Your leadership frees the CEO to concentrate on fundraising, partnerships, and high-level strategy.
- Financial Oversight & Resource Allocation: Manage and forecast budgets across departments, ensuring cost-effectiveness and alignment with strategic priorities. Provide ongoing financial reporting and scenario planning to inform executive decisions.
- WITHIN THE FIRST 3-6 MONTHS, YOU WILL HAVE:
- Established Quick Wins on Regulatory Compliance by creating an internal FDA-readiness checklist for upcoming interactions (e.g., Type C meetings).
- Built an Integrated Project Plan Templates (e.g., Gantt chart) that visually aligns CMC, nonclinical, and clinical milestones for leadership and the board.
- Hosted Two Company Retreats to strengthen team cohesion and strategic alignment.
- Negotiated or Supported Master Service Agreements with supply chain and CRO/CMO partners, ensuring uninterrupted production for clinical trials.
- Hacker Mindset & Resourcefulness: Comfortable improvising in a fast-growing startup, finding pragmatic solutions to complex problems.
- Excellent Communication & Cross-Functional Leadership: E.g. Skilled at presenting nuanced operational and financial data to both technical teams and investor audiences.
- Rigor & Detail Oriented: Meticulous in building financial models, project plans, and risk assessments.
- Resilience & Toughness: Demonstrated success in high-pressure, fast-paced environments. Comfortable acting as a key decision-maker and "go-to" problem-solver for the CEO and board.
- Regulatory & Clinical Acumen: Familiarity with drug development timelines, especially for combination products requiring scale-up in CMC, regulatory, and clinical frameworks.
- Technological Savvy: Able to incorporate modern tools (project management software, data dashboards, AI-driven workflows) to streamline operations.
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