Clinical Development Contract, Senior Manager, Bioanalytical Development (DMPK, Immunogenicity) - Remote to Hybrid Cambridge, Massachusetts
Orbis Clinical is seeking a Contract, Senior Manager, Bioanalytical Development (DMPK, Immunogenicity) located in Cambridge, MA (Remote to Hybrid) for 12 months.
Job Title: Contract, Senior Manager, Bioanalytical Development (DMPK, Immunogenicity)
Location: Remote to Hybrid – looking for candidates local to Greater Boston area. Gradually move to hybrid schedule towards second half of assignment, 2 days onsite Bedford, MA.
Contract: 12 months
Job Summary:
The department of Quantitative & Clinical Pharmacology (QCP) at company is seeking applicants for a Senior Scientist of Bioanalytical Development in DMPK and Immunogenicity. This role will lead the development, validation and execution of PK and ADA assays in clinical and nonclinical studies to enable lead optimization, clinical candidate selection, pharmacology evaluations on safety and efficacy and contribute to regulatory filings. The incumbent will serve as a functional area representative and partner closely with QCP, Translational Biology, Clinical Operations, Nonclinical Development and Operations. A successful candidate must have demonstrated success in assay development and validation, clinical and nonclinical study support, regulatory compliant data analysis/reporting and CRO management. Experience in oligonucleotides therapeutics (ONTs) including siRNA, ASOs, conjugated ONTs, as well as complex biological matrices (CSF, tissues) is a must.
Role Responsibilities:
- Design, optimize, and validate robust, high-sensitivity analytical methods (e.g., LC-MS/MS, hybrid-ELISA, and qPCR) for ONTs and metabolites
- Design, optimize, and validate ligand-binding assays (e.g., ELISA, MSD ECL) for large molecule PK and immunogenicity (ADA, NAb)
- Oversee life cycle management of bioanalytical assays from early-stage development through registration and across evolving program objectives
- Serve as the primary contact for CROs, managing technical oversight of method development, assay transfers, sample analysis, troubleshooting and auditing to ensure high data standards and quality
- Provide SME and technical expertise on nonclinical and clinical study teams, contributing to study protocol development, lab manuals, sample management and bioanalytical data reporting
- Analyze, interpret and report complex data (PK and immunogenicity) to support in vitro/in vivo ADME, DMPK, TK, and PK/PD data evaluations across nonclinical and clinical development
- Ensure all bioanalytical activities are compliant with global regulatory guidelines and ICH M10 requirements, and support IND and NDA filings
Qualifications:
- Ph.D. in Medicinal Chemistry, Analytical Chemistry, Biochemistry, or related field and 3 to 5 years of Analytical and/or Bioanalytical Chemistry laboratory experience including study and CRO management
- Proven success and hands-on experience in the development of oligonucleotide bioanalytical methods and sample extraction techniques for tissue and fluid-based matrices
- Strong understanding of oligonucleotide chemistry, conjugation and linker platforms
- Demonstrates inter-disciplinary knowledge of drug discovery and development (in vitro/in vivo pharmacology, ADME, PK/PD, translational and clinical research)
- Proficiency in GLP/GCP-compliant laboratory regulations, ICH guidelines and procedures
- Strong written and verbal communication skills for data reporting, interpretation and presentation, and cross-functional team collaboration
Compensation Details:
- Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
- The Pay Range for this position is $77.41 – $96.55 per hour, can vary depending on employment status.
- Orbis Clinical provides W2 Employees with options for Health Benefits and 401K.
EEO and Reasonable Accommodation Statement:
Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.
By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.
