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Stealth Mode · 1 month ago

Associate Director, Clinical Development

United States

Full-time

Remote

Lead/Staff, Director/Executive

$165K/yr - $180K/yr

5+ years exp

Stealth Mode is a Series A biotechnology company focused on next-generation protein engineering and vaccine science. The Associate Director, Clinical Development will coordinate and execute clinical trials for novel vaccine candidates, ensuring subject safety and data integrity while influencing scientific direction across the company’s portfolio.

Software

No H1B

Responsibilities

Plan and execute Phase 1 clinical trials in healthy volunteers, ensuring scientific excellence, participant safety, and data integrity

Apply trial operations expertise to guide study design, dosing strategies, and real-time safety oversight

Oversee safety data review and adverse event evaluation, collaborating closely with contracted clinical trials site and monitoring teams to safeguard participants on behalf of the Sponsor

Support site selection, initiation, performance, and monitoring to ensure high-quality and compliant trials

Ensure quality and compliance by upholding GCP standards, regulatory expectations, and ethical conduct to build a strong foundation for later-stage development

Support preparation of regulatory and ethical submissions to applicable domestic and international authorities, ensuring submission materials meet global standards and effectively communicate clinical and nonclinical data

Qualification

Clinical research expertisePhase 1 clinical trialsGCP complianceProtocol developmentRegulatory submissionsData quality managementCommunication skillsOrganizational skillsMentoring experience

Required

Clinical qualification required: Nurse (RN or BSN), Nurse Practitioner (NP), or Physician Assistant (PA). Current license and certification is not required

5–10 years of progressive experience and responsibility in clinical research & development

Proven track record and expertise supporting early-phase clinical trials, ideally involving healthy volunteer vaccine studies

Experience in protocol development, study start-up, and clinical trial execution, with hands-on involvement in operational oversight, safety data review, and data quality management

Expertise reviewing clinical data listings, safety tables, and monitoring reports to identify trends and issues

Experience supporting or contributing to regulatory submissions (e.g., INDs, safety updates, clinical study reports)

Strong understanding of GCP, ICH, and FDA/EMA expectations for early-phase studies

Prior experience managing or mentoring CROs, vendors, or clinical site staff

Strong organizational and communication skills to coordinate across internal and external partners

Preferred

Experience working in clinical settings or research units, particularly in trial units or academic medical centers conducting investigational vaccine studies