What are the responsibilities and job description for the Contract, Director, Bioanalytical Development (DMPK, Immunogenicity) (327) position at Advanced Clinical?
Location: Remote to start; transition to a hybrid schedule (2 days onsite in Bedford, MA) in the latter part of the assignment. Preference for candidates in the Greater Boston area.
About the RoleAn opportunity is available for a Director of Bioanalytical Development to lead assay strategy and execution across DMPK and immunogenicity programs. This leadership role is responsible for overseeing the development, validation, and implementation of PK and ADA assays supporting both nonclinical and clinical studies.
This position plays a critical role in advancing drug development programs—from lead optimization through clinical candidate selection and regulatory submission—while partnering cross-functionally across research, development, and operations teams.
Key ResponsibilitiesLeadership & Strategy
- Lead bioanalytical development for PK and immunogenicity (ADA/NAb) assays, with a focus on oligonucleotide therapeutics
- Serve as a functional lead, driving scientific strategy and execution across programs
- Provide subject matter expertise across nonclinical and clinical study teams
Assay Development & Validation
- Design, optimize, and validate high-sensitivity analytical methods (e.g., LC-MS/MS, hybrid-ELISA, qPCR) for oligonucleotides and metabolites
- Develop and validate ligand-binding assays (e.g., ELISA, MSD ECL) for large molecule PK and immunogenicity
- Oversee full assay lifecycle from early development through registration
CRO & Study Oversight
- Act as primary point of contact for CRO partners, providing technical oversight for method development, assay transfer, sample analysis, and troubleshooting
- Ensure quality, consistency, and compliance across outsourced activities, including audit readiness
Data Analysis & Regulatory Support
- Analyze, interpret, and report PK and immunogenicity data to support ADME, DMPK, TK, and PK/PD evaluations
- Contribute to study design, protocols, lab manuals, and sample management strategies
- Ensure all activities align with global regulatory standards (GLP/GCP, ICH guidelines including ICH M10)
- Support regulatory submissions, including IND and NDA filings
- Ph.D. in Analytical Chemistry, Biochemistry, Medicinal Chemistry, or related field
- 7 years of experience in PK bioanalytical development with immunogenicity (ADA) expertise in biotech or pharmaceutical settings
- Demonstrated success in oligonucleotide bioanalysis (siRNA, ASOs, conjugated ONTs), including complex biological matrices (e.g., CSF, tissue)
- Strong understanding of oligonucleotide chemistry, conjugation strategies, and linker technologies
- Experience managing CROs and supporting both nonclinical and clinical studies
- Deep knowledge of GLP/GCP regulations and ICH guidelines
Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com.