PK Bioanalysis Director
Location: Global
Department: Bioanalytical Sciences
Experience Required: 8–13+ Years (degree dependent)
Industry: Pharmaceuticals / Biotechnology
Position Summary
The PK Bioanalysis Director is responsible for overseeing outsourced regulated bioanalytical activities to support pharmacokinetic (PK) assessments for nonclinical and clinical programs. This role requires strong expertise in LC-MS/MS–based bioanalysis for small molecules and a deep understanding of regulated method development and validation. Experience with anti-drug antibody (ADA) assays is preferred.
The Director will manage vendor relationships, ensure compliance with GLP/GCP, maintain high scientific standards, and contribute to regulatory submissions.
Key Responsibilities
Bioanalytical Leadership
Lead and manage outsourced regulated bioanalysis for small molecules using LC-MS/MS.
Collaborate with CRO partners to establish robust and compliant bioanalytical methods for nonclinical and clinical PK studies.
Ensure that assay strategies support program timelines, scientific needs, and regulatory expectations.
Scientific and Regulatory Oversight
Review method validation plans, sample analysis protocols, raw data, and final reports to ensure quality and compliance.
Ensure adherence to GLP and GCP guidelines across all outsourced bioanalytical activities.
Contribute to regulatory submissions including INDs, CTAs, NDAs, and responses to authorities.
Project and Vendor Management
Serve as project manager for outsourced bioanalytical programs.
Oversee project timelines, budgets, contracts, and deliverables with CROs.
Ensure alignment between internal development goals and external partners.
Supervisory Responsibilities
This position does not include direct supervisory duties.
Education & Experience Requirements
Education
BS in Chemistry or related field with 13+ years of relevant experience, or
MS in Analytical Chemistry or related field with 11+ years of relevant experience, or
PhD in Analytical Chemistry or related discipline with 8+ years of relevant experience, or
Equivalent combination of education and experience.
Experience
Extensive experience in regulated bioanalysis supporting clinical-stage programs.
Strong working knowledge of GLP, GCP, and global regulatory requirements.
Hands-on expertise with LC-MS/MS for small-molecule analysis; experience with ADA assays preferred.
Proven experience in CRO oversight and vendor management.
Background in project management within bioanalytical or PK functions.
Knowledge, Skills, and Abilities
Deep understanding of bioanalytical method development, validation, and sample analysis.
Strong proficiency with LC-MS/MS platforms and immunoassay technologies.
Familiarity with Watson LIMS and standard software applications (Word, Excel, PowerPoint).
Excellent organizational, documentation, problem-solving, and technical writing skills.
Ability to collaborate effectively across scientific, operational, and quality-focused teams.
Strong communication and interpersonal skills with the ability to influence and lead cross-functional discussions.
Demonstrated ability to evaluate scientific and compliance-related challenges and propose effective solutions.
Work Environment
Modern open-plan office environment designed for collaboration and innovation.
Equipped with ergonomic setups, dual monitors, and a supportive team culture.
Compensation
Base Salary Range:
USD $163,000 – $232,000 annually
(Compensation varies by geographic location, experience, skill set, and internal equity.)
Total Rewards Package Includes:
Comprehensive medical, dental, and vision coverage
401(k) with competitive company contributions
Life and disability insurance
Flexible spending accounts
Annual bonus eligibility
Employee stock purchase options and long-term incentives
15 vacation days (first year)
17 paid holidays, including winter shutdown
Up to 10 annual sick days
Equal Opportunity Statement
We are an Equal Opportunity Employer and do not discriminate based on race, color, gender, age, national origin, religion, sexual orientation, gender identity, veteran status, disability, or any protected category.
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