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Clinical Development Contract, Senior Manager, Bioanalytical Development (DMPK, Immunogenicity) - Remote to Hybrid Cambridge , MA
ID: 24962

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.


The Company is an equal opportunity employer and makes employment decisions on the basis of merit. The Company prohibits unlawful discrimination on the basis of race, color, national origin, ancestry, religion, creed, age, sex, sexual orientation, gender identity, pregnancy, marital status, physical or mental disability, medical condition or any other consideration made unlawful by federal, state or local laws. The Company will also provide reasonable accommodation to the known physical or mental disability of an otherwise qualified employee or applicant. Should you need any such accommodation, please contact the Company for further information. The Company is dedicated to ensuring that all decisions regarding personnel are in accordance with all applicable laws. I certify that all statements made in this application are true to the best of my knowledge. I understand that all falsification or misleading information given in my application may result in the termination of my employment with Orbis Clinical and its subsidiaries. Furthermore, I understand that my professional conduct and clinical performance is directly related to my ability to be placed on assignments for Orbis Clinical and that I will adhere to all regulations and guidelines of Orbis Clinical. I authorization Orbis Clinical to verify the information I have provided, to contact references, and to conduct criminal, education and personal background checks concerning my qualifications, and past employment record. I understand that nothing contained in this application is intended to create an employment contract, either verbal or written, with Orbis Clinical or its clients. Furthermore, I understand that my employment, it is “at will” and Orbis Clinical or I may terminate my employment at any time with or without notice and with or without case. I acknowledge that I will be legally obligated by the terms of this document by typing my name, which will constitute my signature, or manually signing, in the provided space and electronically transmitting this document to Orbis Clinical. I agree that Orbis Clinical and I may use electronic means to conduct this transaction and that this document shall be governed and construed by the laws of the State of Massachusetts.