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Associate Director, Clinical Development (Clinical Science) – Immunology

3 weeks, 2 days ago
United States
Full-time
Senior
Program Manager
Project and Program Management
GCP
Apply Now
Apogee Therapeutics

Apogee Therapeutics

Apogee Therapeutics, Inc. is a biotechnology company dedicated to developing innovative biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immune diseases with high unmet needs. Their goa...

Biotechnology
1-10
Founded 2022
$169M raised
View All Jobs 20

Description

  • Monitor clinical trial conduct for quality, safety, protocol compliance, and data integrity.
  • Review and interpret emerging clinical trial data, including safety, efficacy, and operational trends.
  • Collaborate on the development and review of clinical documents such as protocols, informed consent forms, investigator brochures, clinical study reports, medical monitoring plans, safety narratives, and scientific presentations.
  • Partner with Data Management and Biostatistics to support data review, data cleaning, database locks, and validation of data collection tools.
  • Work 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 external stakeholders.
  • Stay current on developments in atopic dermatitis and immunology to support competitive awareness and strategic planning.
  • Support inspection readiness and ensure compliance with GCP and applicable regulatory requirements.
  • Partner closely with the Medical Director and cross-functional study team to plan, implement, execute, monitor, and interpret clinical studies.

Requirements

  • Advanced degree in life sciences, such as 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 and 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.
  • Approximately 25% travel required, including US and international travel, Apogee All Hands meetings, site visits, and medical congresses.

Benefits

  • Anticipated salary range of $180,000-$210,000 per year.
  • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare, and retirement benefits.
  • Three weeks of PTO.
  • Two one-week company-wide shutdowns each year.
  • Dedicated paid sick leave.
  • Access to resources that support professional development.
  • Regular all-team in-person meetings to build relationships and solve problems.

Interested in this position?

Apply directly on the company website

Apply Now

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