Senior Director, Biomarker Discovery and Development

Biomarker Science & Operations       ·        South San Francisco, CA, United States (Hybrid)       ·       Full time 

At Alector, our mission is to develop therapies that empower the immune system to combat neurodegeneration and cancer. Our team is solely 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, leading healthcare investors, and pharma company partners who share in our commitment to bettering the lives of patients.

As the Senior Director, Biomarker Discovery and Development, reporting to our President, Head of R&D, you will be responsible for the scientific, strategic, and managerial leadership of the team of scientists, and will be accountable for all biomarker discovery and development deliverables. This group provides biomarker and translational science support to inform the clinical development of Alector’s programs across neurodegeneration and oncology. Our biomarker strategies are developed for all stages in the drug development path starting from the research discovery phase all the way through approval of the drug. We focus on pharmacodynamic and disease biomarkers as well as patient selection markers to enable our vision of “the right drug for the right patient at the right dose”. In this capacity

You’ll closely collaborate with research biologists, assay development scientists, clinical scientists, biostatisticians, regulatory, clinical operations, and project team leaders. You’ll also work closely with Research to ensure biomarker discovery is taking place early in the molecule interrogation process. You are accountable for ensuring that appropriate biomarker strategies are developed using state-of-the-art technologies that novel biomarkers are discovered in the research and preclinical stages of the projects from literature, and are fully integrated into clinical plans allowing for informed decision making in our clinical studies.

At Alector, we have a broad portfolio of programs in the clinic and in discovery research. This position will be critical in setting the strategy to move these programs forward as efficiently as possible. You will apply your existing technical skills, learn new skills, and play a key role in bringing ground-breaking therapies to our patients. 

During the first year, your responsibilities and goals will include:

• Develop and execute an innovative translational and biomarker strategy working across the pipeline, from early discovery through clinical studies
• Lead team of scientists responsible for biomarker strategies for the entire portfolio
• Lead the design, development, timeline management, and execution of:
• Biomarker discovery efforts
• Clinical biomarker strategies
• Biomarker assay implementation in clinical studies
• Biomarker sections of regulatory documents, eg clinical protocols, INDs, investigator brochures, other external presentations, information and materials
• Translational studies bridging research and biomarker questions in clinical trials
• Reverse translation approaches using biomarker and other data from clinical trials
• Review materials and are subject matter expert on various internal committees (e.g., DRC) regarding biomarker strategies, priorities, implementation, or data analyses.
• Provide direct reports with ongoing mentorship, development and leadership.
• Stay abreast of internal and external developments, trends and other dynamics relevant to the work of Alector to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s).
• Design and oversee the use of biomarkers in clinical studies, writing protocols for incorporation of biomarkers in clinical trials, training trial sites, or clinical CROs to ensure protocols are followed, overseeing the analysis of markers in clinical samples, and preparing reports suitable for regulatory documents.
• Collaborate with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists, and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups across Alector.
• Play a leadership role in ongoing improvements/development of team processes, structures, systems, tools, and other resources.
• Collaborate with the regulatory and clinical teams to develop accelerated approval strategies based on biomarker endpoints. 

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

• A PhD degree or MD/PhD in a relevant scientific field – e.g. immunology, neuroscience, molecular biology, cancer biology, with deep experience and exposure to the discovery and development of biomarkers, either in a research or clinical setting.
• Proven experience in the neuroscience therapeutic area and/or oncology is required.
• 12-15 years of experience in drug development and translational research including discovery, development, and utilization of biomarkers and their associated technologies in an academic and/or industry setting.
• A minimum of 10 years of experience managing a team.
• Strong collaboration skills
• Requires deep knowledge base and experience in translational science, interpreting and analyzing scientific data with solid judgment skills in application and relevance in the clinical setting.
• Extensive experience in areas of basic research as well as translational science and clinical development
• Broad experience in the principles and techniques of discovery, data analysis, interpretation, and clinical relevance.
• Strong scientific skills in translational biology
• Excellent communication skills and the ability to work on interdepartmental project teams and on external collaborations.
• Take pride in your individual contributions, your decision-making acumen, and your ability to work well with, cross-functionally influence, and lead others. 

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Alector is a phenomenal place to learn and grow. Alector is a dynamic environment where teams are encouraged to experiment, take ownership of decisions, and question convention to solve complex problems. At Alector, we value shared wins, perseverance, and a growth mindset.

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

Among the things you’ll discover at Alector on Day 1 and throughout your tenure: Committed and driven colleagues, a bold and important company goal, brand-new brightly lit offices in Oyster Point, right at the heart of Biotech Bay. Alector offers flexible remote work options, and competitive compensation and benefits. Come join us!

At Alector, 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.

Employees of Alector working on-site are required to be vaccinated against COVID-19, and are required to provide proof of vaccination. Employees may be entitled to an exception or reasonable accommodation if they cannot be vaccinated because of a disability/medical necessity, or sincerely held religious belief. 

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

Please click here to apply.