Original listing text, shown exactly as published by the company.
Key Responsibilities
- Monitor clinical trial conduct for quality, safety, protocol compliance, and data integrity
- Perform ongoing review and interpretation of emerging clinical trial data, including safety, efficacy, and operational trends
- Collaborate cross-functionally to develop and review key clinical documents including protocols, informed consent forms, investigator brochures, clinical study reports, medical monitoring plans, safety narratives, and scientific presentations
- Collaborate with Data Management and Biostatistics to support data review, data cleaning activities, database locks, and validation of data collection tools
- Partner closely with Clinical Operations and CRO partners to support site management, enrollment and retention strategy, issue escalation, and study execution
- Develop strong working relationships with investigators, study coordinators, and key external stakeholders
- Stay current on scientific and clinical developments in atopic dermatitis and immunology to support competitive awareness and strategic planning
- Support inspection readiness activities and ensure compliance with GCP and applicable regulatory requirements
Ideal Candidate
- Advanced degree in life sciences (e.g., PhD, PharmD, APNP, DVM, or equivalent clinical/scientific training)
- Minimum 5+ years of relevant clinical research experience, including biotechnology or pharmaceutical industry experience in Clinical Development
- Prior experience supporting clinical trials in immunology, dermatology, or atopic dermatitis preferred
- Strong understanding of clinical trial conduct, safety review, data interpretation, and cross-functional study execution
- Ability to analyze and interpret complex clinical data and communicate findings clearly
- Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment
- Excellent communication, presentation, and technical writing skills
- Proven ability to work effectively in cross-functional teams and collaborate with internal and external stakeholders
- Working knowledge of GCP and global clinical trial regulations
- Demonstrated alignment with Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless
- Approximately 25% travel required (may include both US and international travel), including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year, site visits, and medical congresses
The anticipated salary range for candidates for this role will be $180,000-$210,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.