Clinical Trial Manager

Clinical Science        ·        South San Francisco, CA, United States       ·       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 a Clinical Trial Manager in the clinical operations team, you’ll work closely with the CMO, Regulatory and other key functions both internally and externally to support the critical Alector programs forward. You will 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, play a key role in clinical trial planning and execution and help grow the company and guide its direction.

In this role, you will be responsible for the operational management, including documentation and reporting requirements of a clinical development program. They will work directly with the VP of Operations, CMO, Regulatory, and other key functions internally and externally to ensure the successful completion of all clinical activities/project deliverables within the required time frame and budget. 

During your first year, goals will include:

• Support Study Lead in clinical trial planning through interaction with Key Opinion Leaders and Scientific Advisors
• All study activities at a program level, including investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports
• Vendor management including CROs, central labs, imaging, COAs
• Phase 2 study start-up and planning for phase 2 across indications
• Lead creation of monitoring plans, coordinating study reports, sections for Investigator’s Brochures, and Regulatory documents (e.g., IND, NDA, or BLA)
• Plan resources and tasks to meet program objectives for timely initiation and completion of clinical studies
• Develop and review SOPs and guidelines for compliance with global regulatory requirements, including establishing appropriate processes and procedures to conduct global clinical trials
• Establish systems for tracking various activities during clinical trials, e.g., tracking of clinical reviews, data query resolution, etc.
• Potential to elevate to the next level 

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

• Experience leading global Phase I-III clinical trials, particularly with a focus on Neuroscience, Oncology, orphan diseases, and/or Immunology
• Excellent project management skills and In-depth knowledge of ICH GCP guidelines
• An academic background that includes a Bachelor’s with 4+ years experience in clinical study management within a Pharmaceutical, Biotechnology company, or at a CRO
• Actively participated in leading clinical trial planning and execution from Phases 1-3. Oncology/Neuroscience experience is preferred
• Experience in leading and managing, trials including CROs, consultants, and vendors specific to the therapeutic areas (Neuroscience, Oncology)
• Take pride in being a team player, savvy, self-motivated, and efficient
• Proven track record of being a self-starter and troubleshooting independently
• Thrive in an environment where work is done independently and on teams

#LI-FS1

#LI-Hybrid

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.