Associate Director, Bioanalytical Sciences

Job description

Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. By harnessing advancements in genetics, immunology and neuroscience, we are pioneering the development of potential therapies to counteract the devastating progression of neurodegeneration. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare investors, and pharma company partners, who share in our commitment to bettering the lives of patients and realizing a world where we make brain disorders history. This role is based at Alector’s headquarters in South San Francisco, CA. Regular onsite presence is essential given the combination of hands-on laboratory work, scientific leadership, and close collaboration with multidisciplinary teams As an Associate Director, Bioanalytical Sciences you will provide strategic and hands-on scientific leadership for bioanalytical activities across Alector’s nonclinical and clinical programs. This role combines portfolio-level bioanalytical strategy with direct laboratory engagement and independent assay development. Leverage your deep expertise in ligand-binding assays for pharmacokinetics, and immunogenicity assessments across a range of biological matrices, comfortably move between the hands-on laboratory work and scientific and people leadership. This role encompasses bioanalytical strategy, independent assay development, optimization, and troubleshooting at the bench, CRO oversight, data interpretation and operational decision-making for the group rather than simply coordinating or delegating activities. ### Key Goals & Accountabilities - Define and drive bioanalytical strategy across programs! Develop fit-for-purpose Pharmacokinetic, Pharmacodynamic, immunogenicity, and biomarker strategies that address key scientific questions, anticipate assay needs, identify risks early, and support timely nonclinical and clinical program decisions. - Lead assay development and stay hands-on in the laboratory! Independently design, develop, optimize, troubleshoot, and qualify ligand-binding assays using both ELISA and MSD platforms, with proven experience developing assays for antibodies, including PK, ADA, and neutralizing antibody assays. - Translate bioanalytical data into clear scientific decisions! Interpret complex results across programs, communicate findings and risks to multidisciplinary teams, and author or critically review high-quality bioanalytical plans, technical reports, study reports, and related scientific documentation. - Partner across functions and proactively align expectations! Work with Research, Toxicology, and Clinical Development to align Bioanalytical Sciences priorities, timelines, and capacity with program needs, protecting the team from conflicting demands while continuously improving processes, SOPs, and documentation standards. - Lead and develop the team! Build a culture of scientific rigor, accountability, and respect where team members feel comfortable raising questions and challenging assumptions; mentor scientists at all experience levels in a way that removes barriers rather than adding to their workload. - Build strong external bioanalytical partnerships! Apply a strong understanding of GLP and bioanalytical guidelines when participating in the evaluation and selection of CROs for nonclinical and clinical assay validation and sample analysis; develop robust human bioanalytical assays for transfer to CROs and provide scientific oversight of method transfer, validation, sample analysis, troubleshooting, deviations, data quality, timelines, and final study reports. Hold vendors accountable for quality and timelines while maintaining productive professional partnerships. - Strengthen our bioanalytical capabilities! Develop scientists, establish high standards for experimental rigor and data integrity, and integrate innovative technologies, including laboratory automation, AI, and large language models, to accelerate programs, improve quality, and use resources more effectively! ### Required Qualifications - PhD in Biology, Pharmacology, Immunology, Biochemistry, or a related scientific discipline with 8–10 years of biotechnology, CRO or pharmaceutical industry experience following completion of the PhD; alternatively, MS/MSc with 12–15 years of relevant industry experience following graduate training. - Extensive hands-on expertise in both ELISA and MSD assay development, including proven independent experience developing, optimizing, troubleshooting, qualifying, and validating ligand-binding assays for measurement of antibodies and/or bispecific antibodies in biological matrices, together with deep expertise in anti-drug antibody (ADA) and neutralizing antibody (NAb) assay development for biologic therapeutics. - Demonstrated experience developing human bioanalytical assays for transfer to CROs, overseeing external assay validation and sample analysis, interpreting complex bioanalytical data, and authoring high-quality technical and bioanalytical study reports. - Strong working knowledge of current FDA and EMA regulatory guidance and industry expectations for bioanalytical method development, validation, immunogenicity assessment, and regulated bioanalysis, with demonstrated ability to translate these expectations into appropriate assay strategies and execution. - Demonstrated ability to establish bioanalytical strategy across multiple programs while remaining hands-on in the laboratory; experience leading and developing scientists; ability to succeed in a fast-paced, multidisciplinary environment with shifting timelines and priorities. - Self-motivated, deadline oriented, and comfortable making sound decisions with incomplete information, learning new skills, troubleshooting independently, and adjusting approach as priorities and data evolve. - Hands-on experience using Benchling as an electronic laboratory notebook and maintaining complete, timely, and rigorous electronic laboratory records; and active use of large language models (LLMs) with a strong interest in evolving AI technologies. ### Preferred Qualifications - Experience developing bioanalytical assays, including hybrid ELISA approaches, for siRNA, oligonucleotide therapeutics, or antibody-conjugated siRNA/oligonucleotide modalities. - Experience developing and implementing biomarker assays to support nonclinical or clinical programs.