About Us

We are an early-stage biotech company driven by the mission to develop innovative therapies in the field of aging biology and related areas. Our team is passionate about pioneering fixed-dose combination drugs that address the root causes of aging, accelerating time to clinic, and championing new regulatory pathways to define aging as an official indication. Our current seed funding is $15M, and we plan to significantly expand our operations and team over the next 12–24 months.

Read more in our Candidate Guide.

Why This Role Matters

Without this COO role, we will not be able to:

• Integrate Cross-Functional Teams: Ensure alignment across departments each departmental is aligned (CMC, Clinical, Regulatory, Commercial, etc.) in order to prevent costly delays to our combination products’ development timelines.

• Provide Operational Transparency: Build effective reporting and scorecards so that our CEO, board members, and investors have real-time visibility into all major workstreams.

• Optimize and Scale Operations: Develop the processes, systems, and organizational culture needed to manage rapid growth, including robust financial planning, operationalizing a physical office, and scaling international teams.

• Enable the CEO to Focus on Strategic Initiatives: Take on day-to-day operational oversight so the CEO can concentrate on fundraising, high-level strategic proposals, and essential external partnerships.

• Maintain Quality and Compliance: Implement rigorous QA/QC frameworks crucial for FDA standards, especially for complex combination products.

Key Responsibilities

1. Departmental Accountability & Integration

   • Oversee and coordinate with department heads (CMC, Regulatory, Clinical, etc.) to ensure milestones are met on schedule.

   • Serve as the primary conduit for cross-functional alignment, resolving potential bottlenecks early.

2. Organizational Culture & Process Optimization

   • Foster a collaborative, results-driven, and “no-assholes” culture consistent with our core values (Ownership, Hacker Mindset, Rigor, Communication, Care).

   • Develop and refine processes (OKRs, project management frameworks) that streamline cross-departmental collaborations and decision-making.

3. Hiring & Team Development

   • Oversee strategic hiring plans, ensuring we attract and retain top talent.

   • Implement clear onboarding protocols and continuous development programs, scaling teams from 5–25+ FTEs.

4. 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.

5. Back-Office & Operational Excellence

   • Ensure critical back-office functions (HR, IT, Legal, Facilities) run smoothly, providing a stable foundation for scientific and commercial activities.

   • Oversee the implementation of key systems (e.g., QMS, GxP frameworks) to support regulatory and clinical requirements.

6. Strategic Partnership & Regulatory Coordination

   • Act as an operational liaison with third-party vendors, CROs, and CMOs, especially regarding combination drug manufacturing and supply chain management.

   • Provide interim oversight or support to CMC, regulatory, and clinical teams, ensuring our programs meet FDA standards and timelines.

7. Accountability to CEO & Board

   • Serve as a challenging but supportive counterbalance to the CEO, helping refine strategic initiatives and ensuring follow-through on key deliverables.

   • Regularly report progress to the board, highlighting risks, opportunities, and key performance indicators across workstreams.

Success Measures

Within the First 3–6 Months, You Will Have:

• 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.

• 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.

Within the First Year, You Will Have:

• 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.).

• 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.

• Implemented a Globally Recognized Quality Management System (QMS) that addresses all combination-product regulatory requirements.

Required Skills & Competencies

1. Hacker Mindset & Resourcefulness

   • Comfortable improvising in a fast-growing startup, finding pragmatic solutions to complex problems.

   • Willing to take smart risks and iterate quickly.

2. Excellent Communication & Cross-Functional Leadership

   • Proven ability to engage, motivate, and hold teams accountable across diverse technical and business areas.

   • Skilled at presenting nuanced operational and financial data to both technical teams and investor audiences.

3. Rigor & Detail Orientation

   • Experience implementing QA/QC or compliance frameworks in regulated industries.

   • Meticulous in building financial models, project plans, and risk assessments.

4. 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.

5. Regulatory & Clinical Acumen

   • Familiarity with drug development timelines, especially for combination products requiring scale-up in CMC, regulatory, and clinical frameworks.

   • Understanding of global operations and supply chains in biotech or pharma.

6. Technological Savvy

   • Able to incorporate modern tools (project management software, data dashboards, AI-driven workflows) to streamline operations.

   • Comfortable championing digital transformation initiatives in a startup environment.

Preferred Qualifications

• 3+ years of Executive or Senior Operational Experience in biotech, pharma, or a related industry.

• Demonstrable Success Overseeing Phase Transitions (e.g., from preclinical to clinical) and coordinating cross-functional teams.

• Proven Track Record of Establishing Quality Systems (GxP, QMS) and scaling manufacturing processes (especially for combination products).

• Experience 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).

Application Screening Filters

To help us identify the most qualified candidates, please highlight your specific experience in the following areas (applications lacking these details may not be advanced in our process):

1. Management Experience (teams of 5+): Provide examples of how you’ve built or scaled teams, and your approach to organizational design.

2. Regulatory Submissions: Detail any involvement in IND/CTA filings, FDA meetings, or major regulatory milestones.

3. Quality Systems & CMC: Summarize your track record implementing GxP or QMS frameworks, especially for combination products.

4. Phase Transition Leadership: Describe your direct role in moving a product or pipeline from preclinical to clinical (or early to late stage).

5. Combination-Product or Multi-Component Drug Experience: Outline any past roles where you handled the unique operational challenges of co-formulated therapies.

6. Large-Scale Vendor Management: Have you successfully led contract negotiations, established Master Service Agreements, or overseen CRO/CMO partnerships that involved supply chain and manufacturing for complex drug modalities?