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, educ
Additional Information
About Apogee Therapeutics
Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee's antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company's most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today's standard of care.
We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: C aring, O riginal, R esilient and E goless and a commitment to refusing to stop at "good enough".
If this sounds like you, keep reading!
Role Summary
Apogee Therapeutics is seeking an experienced Clinical Scientist for an Associate Director, Clinical Development (non-MD) role supporting the scientific planning and execution of one or more clinical studies in dermatology. This individual will partner closely with the Medical Director and cross-functional study team to support the planning, implementation, execution, monitoring, and interpretation of clinical studies to advance the development of innovative dermatology clinical trials.
This role is highly collaborative and execution-focused and will involve close partnership with Clinical Operations, Biostatistics, Data Management, Medical Writing, Regulatory Affairs, and Medical Affairs to ensure successful delivery of clinical development objectives.
Apogeetherapeutics · Worldwide