Associate Director, Clinical Operations Program Lead

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.

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

As an Associate Director Program Lead, you will be responsible for the management of global clinical programs. You will lead study team, vendors, clinical monitors and clinical sites throughout the life cycle of a clinical program. You will lead a clinical program through the use of vendors and interactions between monitoring, data management, biostatistics, medical writing, safety, regulatory and QA.

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 nonclinical 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.

The AD Program Lead is responsible for the successful implementation of clinical programs, including providing mentorship and oversight of all aspects of international clinical trials within designated program budgets and timelines. Your experience in leading staff as well as mentoring and developing junior staff will be essential to your team’s success. You will represent Clinical Operations at Project team meetings and may represent company at professional events. 

During your first year, your goals will include:

• Support clinical programs planning through interaction with Key Opinion Leaders and Scientific Advisors
• Recruit, hire, mentor and lead CTCs and CTMs
• Participation in protocol development
• Responsible for 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
• Phase 1, 2 and 3 study start up and planning for Multiple indication.
• Oversee creation of monitoring plans, coordinating study reports, input for sections for Investigator’s Brochures, protocol 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.
• Collaborate with local medical affairs colleagues on country specific programs and initiatives 

We’d love to hear from you if:

• You should have strong experience as a Clinical Program Manager and at least 4 years as a Senior Clinical Trial Manager (Sr CTM) in Clinical Operations and have proven proficiency in all relevant areas.
• You have experience leading global Phase I-II clinical trials, particularly with focus on Neuroscience, Oncology, orphan diseases and/or Immunology.
• Are a self starter individual!
• You have ability to participate in or lead departmental critical initiatives
• You possess strong Program and excellent Project management skills and in-depth knowledge of ICH GCP guidelines
• You are detailed oriented with excellent planning , communication and organizational skills
• You are able to work independently but also within a team structure
• You take pride in being savvy, ambitious, 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 demonstrate a track record of being a self starter and troubleshooting independently

Desired:

• Your academic background includes a Bachelor’s with at least 7+ years experience in clinical study management within a Pharmaceutical, Biotechnology company or at a CRO
• You have actively lead clinical programs planning and execution from Phases 1-3. Neuroscience and Immuno-neurology experience is preferred
• You possess through knowledge and understanding of FDA and EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
• You are experienced in leading teams, including CROs, consultants and vendors.
• You have the ability to travel as required for the program

#LI-Hybrid

#LI-RS1

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.