Associate Director, Clinical Research & Operations

Rapalogix Health; United States; On-site; USD 150,000 - 175,000; Full time

Benefits offered by this job

Annual bonus

Equity package

Healthcare coverage

EAP

HSA

Job summary

Rapalogix Health in the United States seeks an Associate Director, Clinical Research & Operations to lead end-to-end research and operational execution of our clinical study portfolio, currently about 10 active studies. This role blends scientific and regulatory expertise with cross-functional collaboration to align study design, vendor selection, site management, data integrity, and claim substantiation.

The ideal candidate will oversee trial design, safety oversight, data management, and

Qualifications

• Bachelor's or Master's in Life Sciences or related field.
• 5+ years clinical operations experience in skincare or dermocosmetics
• Experience managing CROs, sites, and external vendors from contract to closeout

Responsibilities

• Lead protocol design and development for clinical studies.
• Manage CROs, sites, and external vendors.
• Ensure GCP/ICH compliance and safety reporting.
• Oversee data management, CSRs, and study reporting.
• Maintain essential trial documentation and TMFs.

Skills

Cross-functional PM

GCP/ICH knowledge

CRO/vendor management

Timeline management

Dermocosmetics

Education

Bachelor's degree in Life Sciences

Master's degree in Life Sciences

Job description

Rapalogix Health is a biotechnology company pioneering the next evolution in skin health. We translate foundational insights in longevity science into transformative dermatological solutions. While most skincare products target the visible signs of aging, Rapalogix targets the biology that drives aging itself. Our approach is built around selective inhibition of TORC1, one of the most extensively studied and validated signaling pathways in aging biology.

The company is developing an innovative pipeline of prescription therapeutics and professional skincare products, with clinical rigor at the center of everything we build. The Clinical Operations Manager will play a central role in executing the studies that substantiate our science and support our commercial and regulatory strategy.

Position Summary

The Associate Director, Clinical Research & Operations will lead end-to-end research and operational execution of Rapalogix Health's clinical study portfolio, currently comprising approximately 10 active studies. This individual brings deep expertise in non-interventional and topical product research, will own the full lifecycle of study operations from study design, protocol development, and vendor selection through site management, data integrity, and claim substantiation.

The right candidate combines rigorous scientific and regulatory knowledge with the cross-functional agility to manage technical timelines alongside a fast-moving commercial organization. You are comfortable operating with autonomy, managing external partners, and delivering study outputs that meet both clinical and marketing standards.

Key Responsibilities

Trial Design & Protocol Development

• Lead the design and development of clinical study protocols in alignment with R&D and commercial objectives
• Define study endpoints, assessment tools, and methodology appropriate to topical and dermocosmetic product evaluation
• Ensure protocol design meets GCP/ICH guidelines and supports downstream efficacy claim substantiation
• Collaborate with R&D leadership and external scientific advisors to refine study design and research questions

Vendor, CRO, and Site Management

• Identify, evaluate, and manage CROs, clinical sites, and third-party vendors across the study portfolio
• Negotiate contracts, scopes of work, and budgets with external partners
• Oversee site initiation, training, and ongoing performance monitoring to ensure quality and timeline adherence
• Serve as the primary operational point of contact for all CRO and site relationships

Safety & Adverse Event Oversight

• Monitor adverse events and protocol deviations.
• Ensure timely safety reporting and documentation.
• Partner with investigators and CROs to maintain participant safety standards.

Data Management & Clinical Reporting

• Oversee clinical data review, query resolution, and database quality checks.
• Collaborate with biostatisticians and data analysts to ensure accurate interpretation of study results.
• Review clinical study reports (CSRs), final reports, and study summaries.
• Translate study outcomes into claim-support packages and scientific evidence documents.

Clinical Documentation, Quality & Compliance

• Own the development, review, collection, and maintenance of all essential clinical trial documentation, including Case Report Forms (CRFs), source documentation, Investigator Site Files (ISFs), Trial Master Files (TMFs), Investigator Brochures (IBs), informed consent forms (ICFs), delegation logs, training records, and regulatory documents.
• Ensure all Principal Investigator (PI) qualifications, licenses, CVs, training records, financial disclosure forms, and site regulatory documents are complete, current, and inspection-ready.
• Maintain TMFs in accordance with GCP/ICH requirements and company SOPs, ensuring accuracy, completeness, version control, and audit readiness throughout the study lifecycle.
• Conduct periodic quality reviews of study documentation and collaborate with CROs and sites to resolve documentation gaps, protocol deviations, and compliance issues.
• Support sponsor audits, site audits, and regulatory inspections by ensuring all essential documents are organized, complete, and readily accessible.

Post-Market Clinical Research & Investigator-Initiated Studies

• Planning and execution of post-market clinical studies, real-world evidence programs, and observational research to support product lifecycle management, claim expansion, physician adoption, and long-term evidence generation.
• Evaluate, support, and oversee Investigator-Initiated Studies (IITs) in collaboration with academic investigators, dermatologists, and key opinion leaders (KOLs), ensuring scientific rigor, appropriate governance, and alignment with strategic research objectives.

Qualifications

Required

• Bachelor's or Master's degree in Life Sciences, Biology, Biochemistry, Cosmetic Science, or a related field
• Experience running combination product studies, including device and topical drug combinations
• 5+ years of clinical operations experience, ideally within premium skincare, dermocosmetics, or topical product development
• Deep understanding of non-invasive skin bioengineering tools and dermatological photonumeric scales
• Working knowledge of GCP/ICH regulations and their application to cosmetic and topical clinical research
• Demonstrated ability to manage CROs, clinical sites, and external vendors from contract through closeout
• Exceptional cross-functional project management skills with a track record of delivering studies on time and within budget
• Comfort operating in an early-stage environment with a willingness to provide support across adjacent areas as the team scales and priorities shift

Preferred

• Experience in both interventional and non-interventional study designs within dermatology or cosmetic science
• Familiarity with claim substantiation requirements for physician-dispensed or OTC skincare products
• Experience supporting Phase IV or IIT programs

Rapalogix Offers

Compensation

• Base Salary: $150,000-$175,000 annually
• Bonus: Annual performance-based bonus
• Equity: Competitive early-stage equity package
• 16 Company holidays and unlimited vacation policy
• Comprehensive medical, dental, and vision insurance with fully employer-paid options for employees
• Employee Assistance Program (EAP)
• Flexible spending accounts and health savings account
• Adoption assistance
• Short- and long-term disability coverage
• Basic life and AD&D insurance, plus voluntary life insurance

Rapalogix Health is proud to be an equal employment opportunity and affirmative action employer. We celebrate diversity and do not discriminate based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.