Associate Director, Clinical Operations

Alector, Inc. San Francisco , CA 94118

Posted 11 months ago

At Alector, our mission is to develop therapies that empower the immune system to cure neurodegeneration. Our team is solely focused on developing cures for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and board members, leading healthcare investors and some of the most innovative pharma companies.

Would you like to take part in creating new therapies that really make a difference in patients' lives? Do you desire both autonomy and collaboration in tackling scientific challenges that interest you? Would you like to be part of a talented team where everyone has a voice?

As an Associate Director of Clinical Operations in the clinical operations team, you'll work closely with VP of Operations, CMO, Regulatory and other key functions both internally and externally to advance critical Alector programs forward. You will be able to contribute across 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 development of the programs and help grow the company and guide its direction. As an early hire, you'll be influential in championing and developing Alector's culture.

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

First year goals / responsibilities:

  • Support clinical development through interaction with Key Opinion Leaders and Scientific Advisors in order to design appropriate clinical trials

  • All study activities at a program level, including investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports

  • CRO selection, development of RFPs, budget negotiations and management, and CRO management

  • 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 of various activities during clinical trials, e.g., tracking of clinical reviews, data query resolution, etc.

At Alector, we believe that high-performing 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.

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

Requirements

We'd love to hear from you if:

  • You take pride in being savvy, self-motivated, and efficient

  • You thrive in an environment where we work independently and on teams

  • You have a point of view but are low ego

  • You have experience leading global Phase I-II clinical trials, particularly with focus on Neuroscience, Oncology, orphan diseases and/or Immunology

  • You demonstrate a track record of being a self starter and troubleshooting independently

  • You possess excellent project management skills and In-depth knowledge of ICH GCP guidelines

Desired:

  • Your academic background includes a Bachelor's (advanced degree preferred) with at least 7 years experience in clinical operations, program management within a Pharmaceutical, Biotechnology company or at a CRO

  • You have actively participated in leading clinical development planning through interactions with Key Opinion Leaders and Scientific Advisors in order to design appropriate and novel clinical trials from Phases 1-3. Oncology/Neuroscience experience is preferred

  • You possess excellent project management skills and in-depth knowledge of ICH GCP guidelines

  • You are experienced in leading, managing, and providing guidance to clinical operations study teams including CROs, consultants and vendors

  • You are able to travel as required for the project

Benefits

While we've focused on what to look forward to during the first year and beyond, Day One is great, too: committed and driven colleagues, a bold and important company goal, state-of-the-art brand-new brightly-lit offices in the heart of the biotech area, competitive compensation and benefits. But these matter only if you're excited to build and own something great, and tackle these challenges with us. Come join us.


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Associate Director, Clinical Operations

Alector, Inc.