Associate Director, Biomarkers

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. 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 

As our Associate Director, Biomarkers you will be responsible for developing a strategy and implementing the process to support the lifecycle of all clinical specimens to ensure samples are collected, processed and stored with the highest degree of quality. Accountable for planning, organizing and leading the collection and shipping of bio-samples from investigator sites or Labs and their subsequent delivery to assay laboratories to ensure timely delivery and quality data.

During the first year, your goals will include:

• Planning, organization, and oversight of the entire lifecycle of clinical samples through collection, shipping, processing, storage and subsequent delivery for processing and analysis.
• Maintain oversight of all study biosample operational activities, including sample reconciliation, sample metrics and reporting. Ensure biosample strategy across multiple clinical programs is driven in accordance with the requirements of quality, ethical and regulatory guidelines, including ICH/GCP/GLP.
• Establish, implement, and maintain processes for sample management, including development of SOPs, for consistent practices across the clinical studies.
• Develop study-specific sample management plans, including vendor agreements, site training materials, and engagement with site personnel performing sample collection, processing, and shipping. Lead the development of a Sample Management Plan based on input from scientific and operational partners to implement biomarker operational strategies.
• Develop timelines and all internal resource needs for all biosample operational activities, ensure proper study plans and tracking.
• Lead interactive data visualizations and analytical tools for reporting metrics and trends and data QC and identify and communicate critical trends to study teams
• Participate in the identification, selection and oversight of laboratory vendors including drafting RFPs and defining scope of work in support of study objectives and goals
• Develop the strategy for a scalable sample storage, tracking and access
• Support sample analysis, data transfer, data reconciliation, and data review
• Provide study level updates to partners, clinical study teams and biomarker teams including sample collection, assay status and analysis updates

We'd love to hear from you if you have:

• BA/BS, Clinical Science or a related subject area preferred
• 5 + years industry experience in clinical research at a pharmaceutical, Biotech or CRO.
• Neuroscience and Oncology experience is helpful.
• 2+ years of experience in leading biosample operational activities in large, complex, and multi-center clinical studies.
• Direct experience in handling sample operations of various sample types, including tissue across multiple therapeutic areas.
• Working knowledge of ICH/GCP/GLP regulations and biosample management standard methodologies
• Ability to lead lab vendors and handle bio-sample management activities across multiple clinical trials
• Proven record of success in a cross-functional team environment.
• Clinical research experience in industry, ideally in Neuroscience and Oncology.
• Experience with vendor and CRO management.
• Proficient with sample data reporting, running metrics and understanding the overall quality and stability of study samples.
• Ability to comprehend and show scientific understanding in neuroscience space
• 2+ years of people management experience

#LI-CH3

#LI-Hybrid

At Alector, our vision is bold, people are our priority, and our values are at the core of everything we do. Our dynamic and flexible environment encourages our teams to experiment, take ownership of decisions, and question convention to solve complex problems. We value shared wins, perseverance, and a growth mindset, which drives us forward, together.

Alector was named on Fortune’s "Best Workplaces in Biopharma" top list for small and medium-sized companies for the third consecutive year! And we moved up from #16 to #11 in 2022.

Among the things you'll discover at Alector from your very first day are our committed and driven colleagues, a bold company vision, and new, modern offices designed to inspire innovation and collaboration in South San Francisco, right at the heart of Biotech Bay. Our benefits are thoughtfully designed around Alectorians and their loved ones and include flexible hybrid work options, competitive compensation, and comprehensive and unique benefits that enhance your health and well-being. Come join us! 

We believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.