Senior Director, Clinical Operations

DEVELOPING TREATMENTS FOR RARE AND DEVASTATING DISEASES We need your passion, expertise, and unique perspectives to continue advancing our knowledge in the rare and devastating disease markets. Become part of the Lumos Pharma family. Our current open positions include: EQUAL EMPLOYMENT OPPORTUNITY/AFFIRMATIVE ACTION INFORMATION The Company provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, physical or mental disability, status as a special disabled veteran or other protected veteran, or any other characteristic protected by law. (“sexual orientation: means actual or perceived heterosexuality, homosexuality, or bisexuality, and “gender identity” means gender-related identity regardless of the person’s assigned sex at birth). In addition, the Company complies with applicable federal, state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including but not limited to hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, and compensation. Disability Accommodations for Applicants If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request through one of the methods listed below: Email: View email address on click.appcast.io Recruiting Agencies: Please reach out to us at the above email address. Mailing Address: Attn: Human Resources 2503 South Loop Drive, Suite 5100 Ames, IA 50010 These options are reserved for individuals who require accommodation due to a disability. Position: Senior Director, Clinical Operations Location: Remote Position, US Based Job Id: 424 # of Openings: 1 Lumos Pharma is a clinical‑stage biopharmaceutical company developing therapies for people with rare diseases—focused where medical need is high and pathophysiology is clear. We take a patient‑centric approach and maintain inspection readiness across our programs, guided by a strategy grounded in time–and cost‑efficient drug development. Role summary The Senior Director, Clinical Operations, provides operational leadership across Lumos’ clinical programs, partnering with Clinical Development, Regulatory, CMC, Quality, Patient Engagement, and other cross‑functional teams. This role is accountable for planning and executing clinical trials through outsourced partners, ensuring high‑quality delivery, proactive risk management, metric‑driven oversight, budget stewardship, and ongoing inspection readiness. What you’ll do Provide operational leadership across multiple clinical studies, partnering with cross‑functional teams to deliver high‑quality execution. Lead CRO and vendor selection, contracting support, governance, and performance management; build strong relationships with investigators, sites, and vendors. Drive study planning and oversight, including timelines, critical path management, risk mitigation, and contingency planning. Own study‑level operational metrics and reporting; communicate progress, risks, and scope changes to senior leadership and other stakeholders. Assure sufficient ancillary supplies are available for all studies. Oversee vendor deliverables, including work orders/change orders and invoice review/approval, in alignment with budget and scope. Support regulatory and ethics submissions (IRB/EC) in collaboration with CROs and internal stakeholders. Partner with CMC/supply chain teams to forecast, label, ship, and maintain investigational product and ancillary supplies; ensure end‑to‑end drug accountability and reconciliation. Ensure the Trial Master File (TMF) is complete and inspection‑ready; participate in QA and regulatory inspections and audits. Contribute to protocol development, clinical study reports, and other regulatory/clinical documentation (e.g., INDs, Investigator’s Brochure, ISS/ISE). Lead problem‑solving across clinical operations issues; drive continuous improvement, infrastructure build‑out, and SOP development/revision. Develop and manage clinical operations budgets and forecasts; provide operational input to due diligence activities as needed. Coach, mentor, and develop clinical operations team members supporting assigned programs. Qualifications Required Bachelor’s degree in Life Sciences or a related field. 15+ years of experience in clinical operations/clinical development, including senior‑level leadership. 10+ years of experience planning and executing complex global clinical trials. Demonstrated expertise in CRO/vendor oversight, outsourcing strategy, and governance. Strong knowledge of GCP/ICH and applicable regulations; proven ability to apply SOPs and maintain inspection readiness. Experience executing global clinical studies, including site start‑up through close‑out. Ability to travel up to 15%. Preferred Master’s degree or higher. Experience in rare disease drug development and/or clinical‑stage biopharma environments with lean teams. Experience with diagnostic or companion diagnostic development. Experience building or improving clinical operations infrastructure, processes, and SOPs. Work environment This position is remote within the United States. Travel Periodic travel to study sites, investigators, vendors, and team meetings is expected (up to 15%). What you can expect as a Lumosian Generous health and welfare benefits, including company‑paid dental and vision (with dependent coverage), short‑ and long‑term disability, and basic life insurance Lumos covers 85–95% of medical premium Health Reimbursement Arrangement 8 weeks of fully paid parental leave for all new parents #J-18808-Ljbffr