We are seeking an Associate Director, Bioanalytical Development to oversee development and validation of bioanalytical assays supporting clinical and toxicology studies. In this exciting role you will act as the liaison between the bioanalytical team and clinical and non-clinical study teams to effectively manage pharmacokinetics (PK) and immunogenicity deliverables and timelines for clinical and toxicology studies to support Apogee’s pipeline.

Key Responsibilities

• Oversee bioanalytical method development, validation and sample testing for clinical and toxicology studies at CROs. Provide technical support including but not limited to method development and validation protocol design and troubleshooting.
• Review PK and immunogenicity data from clinical and toxicology studies to ensure the quality and integrity of data.
• Act as a liaison between bioanalytical development team and clinical development team, work closely with groups – clinical pharmacology, clinical operation and development teams, and other working groups to establish bioanalytical deliverables and timelines for multiple projects.
• Develop and execute strategies to ensure long term support and data consistency across clinical studies. This includes ensuring long term supply of critical assay reagents and ensuring appropriate assay performance metrics.
• Prepare and review sample analysis documentation and clinical and tox sample analysis reports. Contributes to regulatory submissions and responses to regulatory inquiries.
• Review clinical study-related documents including expanded synopses, protocols, amendments, statistical analysis plan, and clinical study reports.

Ideal Candidate

• Self-motivated and energetic; enjoys working in a fast-paced, team-based, cross-functional setting.
• Possess strong communication skills, demonstrate effective project management abilities, and have excellent interpersonal skills.
• This role requires a PhD with 6 years of hands-on experience in a role related to bioanalytical sciences. Experience with bioanalytical techniques, e.g., ELISA, ECL, MSD and immunogenicity assays required. Extensive experience with cell-based bioassays desired. Experience with writing/reviewing scientific documents, reports, and contributing to regulatory submissions preferred.
• Ability to travel 6 – 8 times per year for All Hands and Tech Ops team meetings is required.

The anticipated salary range for candidates for this role will be $175,000 to $190,000/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.