Associate Director, Bioanalysis

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic and scientific direction for outsourced bioanalytical functions that support clinical development initiatives.

• Supervise bioanalytical method development, qualification, validation, and sample analysis processes.

• Perform scientific troubleshooting and optimization tasks.

• Cultivate and sustain collaborations with bioanalytical CROs and external partners.

• Assess vendor performance and ensure compliance with study timelines, quality benchmarks, contractual commitments, and regulatory guidelines.

• Guarantee that bioanalytical activities align with global regulatory standards and industry best practices.

• Act as the bioanalytical subject matter expert within cross-functional project teams.

• Offer scientific insights and risk evaluations to facilitate decision-making processes.

• Assist in regulatory submissions by preparing submission-related documentation, responding to agency inquiries, and conducting inspection-readiness preparations.

• Analyze emerging analytical technologies, biomarker strategies, and innovative measurement techniques.

• Promote continuous improvement, digital solutions, and operational efficiencies in bioanalysis.

⛳️ Requirements

• Ph.D. with at least 5 years of pertinent industry experience in regulated bioanalysis; or an M.S. or B.S. degree with a minimum of 8 years of relevant industry experience.

• Proven expertise in regulated bioanalysis supporting clinical development, including pharmacokinetic and biomarker assays.

• Strong understanding of global bioanalytical regulatory guidance and industry standards.

• Practical experience and knowledge of LC-MS/MS, ELISA, ECL, flow cytometry, and other relevant platforms.

• Experience with immunogenicity assays, including anti-drug antibody (ADA) and neutralizing antibody (NAb) assays, is advantageous.

• Experience in managing CROs and external collaborations, including oversight of deliverables, budgets, timelines, quality, and compliance.

• Strong project management abilities with the capacity to prioritize and handle multiple complex projects simultaneously.

• Exceptional verbal, written, and presentation skills.

• Capability to convey complex scientific concepts effectively to both technical and non-technical audiences.

• Proven ability to collaborate within cross-functional teams and influence decision-making processes.

🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Company-funded basic life insurance.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• Generous 401(k) matching program.

• Flexible time off.

• Paid holidays.

• Paid leave programs.

• Incentive opportunities.