Senior Clinical Trial Manager – Neurology

Clinical Operations       ·       South San Francisco, CA       ·       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.

As a Senior Clinical Trial Manager on the Clinical Operations Team, you’ll work closely with the Program Manager, Clinical Science, Data Management, Regulatory, and other key functions both internally and externally to support the critical Alector programs. You may contribute to a variety of programs and have broad involvement in work central to Alector’s strategic goals. You will apply your existing technical skills, learn new skills, and play a key role in clinical trial planning and execution to help grow the company and guide its direction.

This role requires an individual who will be responsible for the operational management, including documentation and reporting requirements of a clinical development program. They will work directly with internal and external stakeholders to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget. 

During your first year, goals will include:

• Lead Phase 2 Alzheimer’s study and primary point of contact for operational day-to-day activities and managing clinical trial execution
• Responsible for study activities, including investigator recruitment and site selection, study start-up, enrollment, data collection, drug projections, and reports
• Manage CRO, central lab, system vendors, and ancillary vendors to ensure on target, in budget deliverables with appropriate oversight
• Lead cross-functional Study Team, Stakeholder management with business partners, Key Opinion Leaders and Scientific Advisors, and external partners
• Manage creation of study plans and documents, coordinating study reports, and sections for Investigator’s Brochure and Regulatory documents (e.g., IND, NDA, BLA)
• Establish systems for tracking various activities during clinical trials (e.g., tracking metrics, monitoring reports, data review and query resolution, etc.)
• Plan resources and tasks to meet study and program objectives for timely initiation and completion of clinical studies
• Provide strategic input and leadership in study panning, set-up, and execution
• Contribute SOPs and guidelines in compliance with global regulatory guidelines and requirements.

We’d love to hear from candidates who:

• Have experience leading larger global Phase II-III clinical trials from planning to closeout, particularly with a focus in Neurology (ie Alzheimer’s, ALS, and other neurodegenerative diseases)
• Possess excellent project management skills with ability to prioritize, and collaborate with internal and external personnel
• Have an academic background which includes a Bachelor’s with 7+ years experience in clinical study management within a Pharmaceutical, Biotechnology company or at a CRO
• Are experienced managing CROs, consultants, and vendors in a complex team environment
• In-depth knowledge of FDA, EMEA, and ROW ICH and GCP guidelines
• Take pride in being a great teammate, savvy, self-motivated, and efficient
• Demonstrated track record of being a self-starter and troubleshooting independently
• Thrive in an environment where work is done both independently and on teams
• Managed direct reports and a champion for mentoring their team

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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.

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!

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.

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.