Clinical Science Director

Clinical Science      ·        South San Francisco, CA (Remote)       ·       Full time 

At Alector, our mission is to develop therapies that empower the immune system to combat neurodegeneration. 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.

The Clinical Science Director will be responsible for providing scientific support for clinical development activities. This role sits in the Clinical Science organization and will collaborate closely with Clinical Operations, Biomarkers, Research, Biometrics, Regulatory Affairs, Non-clinical, and Quality Assurance.

The Director of Clinical Science will ensure alignment between strategy and study protocols, operational structure, and operating procedures. You will be responsible for ongoing data analysis, summarizing study results for the preparation of documents and publications, and supporting project teams with scientific information and progress updates related to the assigned clinical studies. Other responsibilities will include leading the development of clinical development-related documents including study synopses and protocols, investigational brochures, clinical study reports, and documents that support the development and execution of clinical studies.

This position will be based in our SSF office or remote.

During your first year, your goals will include:

• Provide strategic direction and lead staff in the design, and execution of the Clinical Science function.
• Provide scientific input to translational studies, clinical development programs, and definition of efficacy and safety endpoints for Phase I, II, and III clinical trials.
• Collaborate with the Medical Monitors and Pharmacovigilance team on medical and safety monitoring, and the review, analysis, and interpretation of study results, including exploratory endpoints, and assure appropriate data review and accurate data reporting.
• Act as Lead clinical development person for studies and collaborate closely with the Study Leader to assure efficient study execution and accurate study conduct.
• Prepare and interpret data and contribute to scientific publications including posters, abstracts, and manuscripts.
• Provide support to advisory boards, consultant meetings, and investigator meetings, including preparation and delivery of presentations.
• Collaborate with Clinical Outcome Assessment (COA) vendors, Imaging vendors, and specialty vendors during study startup and during study execution to enable quality study assessments and troubleshoot issues.
• Provide input and collaborate across all functional areas, including research, non-clinical, biomarkers, clinical pharmacology, clinical operations, project management, biostatics, data management, and regulatory affairs departments.
• Represent the company at investigators’ meetings.
• Co-author relevant sections of clinical documents and publications pertaining to translational biomarkers (e.g., Clinical Protocols, Informed Consent, Clinical Study Reports, Investigator Brochures, abstracts, and manuscripts) and documentation for submission to regulatory agencies.
• Direct medical writing and study team in the development of Clinical Protocols, Investigator Brochures, and other documents owned by the Clinical Science function.

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

• D. in a relevant scientific area with 12+ years of industry experience in the biotechnology or pharmaceutical industry or a combination of academia and industry.
• Deep knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in the design of study protocols is required.
• Direct experience coordinating trial activities, in clinical sample management and biomarker analysis.
• Proven scientific leadership when working with collaborative, multi-functional teams.
• Excellent technical writing and communication skills; able to articulate sophisticated scientific concepts to diverse functional groups and external partners.
• Proven experience authoring submissions documents to regulatory agencies.
• Knowledge of clinical outcome assessments (COAs) and experience working with COA / Rater vendors highly desirable
• A history of strong collaboration and personal interaction with all levels of internal partners including, Regulatory Affairs, Medical Affairs, Clinical Operations, Biometrics, Research, Non-clinical Science, and Product Development.
• Highest level of scientific integrity.
• Strong digital literacy including MS Office (Word, Excel

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Alector is a phenomenal place to learn and experiment. If you excel in a dynamic environment where everyone is committed to finding a treatment, where you’ll drive growth, this is your role. There is no limit to how far you can go with us.

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 the heart of the biotech area, flexible remote work options, and competitive compensation and benefits. But these matters only if you’re excited to build and own something great, and tackle these challenges with us. 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.