(Associate) Director, Bioanalytical Sciences (Mentari Tx)

Real; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Mentari Therapeutics seeks an Associate Director/Director of Bioanalytical Sciences to design and oversee bioanalytical strategies for development programs. You will lead outsourced activities, ensuring PK, ADA/nAb, and biomarker data meet regulatory expectations across GLP/GCLP environments.

The role requires extensive hands‑on expertise, strong CRO oversight, and cross‑functional collaboration with nonclinical development, clinical pharmacology, and translational medicine to deliver

Qualifications

• Advanced degree and 5+ years of industry or CRO experience in bioanalytical sciences.
• Deep expertise in regulated bioanalysis for biologics development.
• Hands-on bioanalytical work in PK/TK, ADA, nAb, and biomarker assays.

Responsibilities

• Lead biosanalytical strategy for clinical and nonclinical studies.
• Manage CROs, timelines, budgets, and regulatory compliance.
• Oversee development, validation, and sample analysis for PK/TK, ADA, nAb, and biomarkers.
• Review data and ensure rigor, data integrity, and regulatory readiness.
• Collaborate across functions to support study design and sample strategy.

Skills

Bioanalytical science

CRO management

Project management

Communication

Education

PhD/MS/BS in a relevant field

Tools

ELISA

MSD/ECL

LC-MS/MS

Job description

Real has been retained by Mentari Therapeutics on the new search for an (Associate) Director, Bioanalytical Sciences.

Company Description

Mentari Therapeutics is a biotechnology company focused on developing preventive therapies for migraine, a debilitating and undertreated neurological condition affecting more than 1 billion people worldwide. The company's lead programs target PACAP, a newly validated pathway that is mechanistically distinct from CGRP, expanding therapeutic options beyond current standards of care. Its pipeline includes MT-001, an anti-PACAP monoclonal antibody designed for convenient subcutaneous administration, and MT-002, a bispecific antibody targeting both CGRP and PACAP to address incomplete responders to CGRP-only therapies. Mentari's programs were discovered by Paragon Therapeutics, and the company is headquartered in Waltham, MA, with a collaborative, science-driven culture. Additional information about Mentari Therapeutics can be found at mentaritx.com.

JOB DESCRIPTION: Associate Director/Director Bioanalytical Sciences

Position Summary

The Associate Director or Director, Bioanalytical Sciences will design and execute bioanalytical strategies to support Mentari Therapeutics' development programs. Reporting to the VP, Head of Clinical Pharmacology, this individual will provide scientific leadership and operational oversight for outsourced bioanalytical activities, with primary responsibility for PK, immunogenicity (ADA/nAb), and biomarker bioanalytical assays supporting biologic therapeutics.

This is a highly technical, hands‑on oversight role. The successful candidate will bring deep expertise in regulated bioanalysis, substantial hands‑on laboratory experience, and a strong track record of managing CRO‑outsourced bioanalysis. The individual will work closely with nonclinical development, clinical pharmacology, translational medicine, and other cross‑functional partners to ensure high‑quality, fit‑for‑purpose bioanalytical data across development programs. The ideal candidate will have strong organizational and communication skills, excellent attention to detail, sound scientific judgement, and the ability to independently manage multiple priorities in a lean, fast‑paced biotech environment.

Key Responsibilities

• Lead bioanalytical strategy and execution for clinical studies and the bioanalytical components of nonclinical studies, partnering with nonclinical development, clinical pharmacology, translational medicine, and other cross‑functional partners to design and implement fit‑for‑purpose bioanalytical approaches across development programs.
• Identify, select, and manage bioanalytical CROs; oversee timelines, budgets, quality, and regulatory compliance; monitor study progress and ensure high‑quality, timely delivery.
• Direct CRO‑led development, optimization, qualification, validation, implementation, and sample analysis for PK/TK, ADA, nAb, and biomarker assays using fit‑for‑purpose approaches appropriate to the intended use.
• Provide scientific and operational oversight of PK/TK, ADA, nAb, and biomarker assays conducted in GLP/GCLP‑regulated environments.
• Review and interpret assay development, validation, and sample‑analysis data, including validation protocols, test procedures, raw data, deviations, and technical reports, to ensure scientific rigor, data integrity, and compliance with regulatory expectations; communicate results to cross‑functional stakeholders.
• Troubleshoot challenging bioanalytical assays with CRO scientists and provide practical experimental recommendations informed by hands‑on laboratory experience.
• Author and review bioanalytical plans, reports, and supporting documentation for regulatory submissions; support responses to regulatory agency questions related to PK bioanalysis, immunogenicity, and biomarker assays.
• Partner cross‑functionally to support bioanalytical sample strategy, sample management, and study execution.
• Identify, source, qualify, and manage critical assay reagents and vendor‑supported activities, including reagent inventory and lifecycle planning.
• Represent the bioanalytical function on cross‑functional project teams and contribute to bioanalytical strategy while driving assigned activities forward independently and proactively.

Required Qualifications

• BS with 10+ years, MS with 8+ years, or PhD with 5+ years of relevant industry or CRO experience in Bioanalytical Sciences, Immunology, Biochemistry, Pharmaceutical Sciences, Laboratory Medicine, or a related scientific discipline. Level will be commensurate with experience.
• Deep expertise in regulated bioanalysis supporting biologics development and clinical‑stage programs.
• Significant hands‑on laboratory experience with PK/TK, ADA, nAb, and biomarker assay development, optimization, validation, and/or execution; candidates should have personally performed bioanalytical work rather than exclusively managed outsourced activities.
• Demonstrated expertise in ligand‑binding assays for biologics; neutralizing antibody assay experience is strongly preferred.
• Experience working in GLP/GCLP‑regulated environments and strong knowledge of applicable bioanalytical method validation, regulated sample analysis, and data‑integrity requirements.
• Strong track record of managing CRO‑outsourced bioanalysis and vendor relationships, including assay development and validation, sample analysis, data review, timelines, budgets, and final reports.
• Ability to critically review validation protocols, test procedures, raw data, deviations, repeat analyses, data exclusions, and technical reports and identify scientific, operational, quality, or compliance concerns.
• Experience with multiple bioanalytical platforms, such as ELISA, MSD/ECL and/or LC‑MS/MS, with the ability to select fit‑for‑purpose approaches.
• Strong communication, organizational, and project management skills, excellent attention to detail, and sound scientific judgement.
• Ability to independently manage multiple priorities effectively and thrive in a lean, fast‑paced biotechnology environment.

Preferred Qualifications

• Combination of sponsor‑side and CRO or regulated laboratory experience.
• Experience supporting monoclonal antibodies, bispecific antibodies, or other large‑molecule therapeutics.
• Experience supporting bioanalysis from first‑in‑human through later‑stage clinical development.
• Experience contributing to regulatory filings and agency responses for biologics.
• Experience supporting CRO qualification, technical audits, laboratory investigations, or regulatory inspections.

Who Will Be Successful

• A bioanalytical subject matter expert who can confidently oversee CRO partners and bioanalytical strategy.
• Self‑directed and proactive, with the ability to take ownership of initiatives and drive them to completion.
• Comfortable wearing multiple hats and collaborating across functions in a small, growing organization.
• An effective problem‑solver who can navigate ambiguity and adapt to evolving priorities.
  

EOE Statement:

Specialist 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, or veteran status.

In addition to base pay, direct‑hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.