Associate Director Clinical Project Management

Job description

Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. By harnessing advancements in genetics, immunology and neuroscience, we are pioneering the development of potential therapies to counteract the devastating progression of neurodegeneration. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare investors, and pharma company partners, who share in our commitment to bettering the lives of patients and realizing a world where we make brain disorders history. As Associate Director Clinical Project Management, you will serve end to end operational delivery of assigned clinical trial studies in support of our product development portfolio and will lead the cross-functional clinical trial team and partners with internal and external team members (CROs and vendors) and other key stakeholders ensuring alignment of activities with study projects and timelines (from study concept, initiation, conduct through closeout and associated final deliverables). Clinical Project Manager will translate protocols, contracts, Alector’s neurogenerative disease program requirements into executable study plans and supervises contracted clinical trial activities to study timelines, scope, budget, risks, dependencies, documentation and corporate deliverables. You will bring clarity to ambiguity and complexity by driving cross-functional alignment, enabling timely decision-making, and ensuring disciplined execution across all phases of development. Reporting to the VP of Clinical Development Operations, you will collaborate with leaders and subject matter experts across Research, Development, Clinical, Regulatory, CMC, and other functions to translate strategy into actionable plans, proactively manage risks, and accelerate program progress. We are looking for someone who thrives in a fast-paced, flexible, evolving biotechnology environment, builds trusted relationships across teams, and enjoys improving how work and finding efficiencies where possible. ### Key Goals & Accountabilities: - Develop, maintain, and execute an integrated clinical development plan strategy that advances clinical development objectives while aligning cross-functional priorities. This involves translation of protocols, contracts and study requirements to support overall strategy. - Lead cross-functional study teams to make informed decisions, resolve complex issues, and maintain clear, proactive communication across stakeholders worldwide. - Design, develop, and manage integrated study project plans with clinical development, including critical path management, scenario planning, milestone tracking, and proactive identification of key risks and opportunities. Routinely re-align contracted vendors to study scope, timelines milestones, deliverables, responsibilities and dependencies. - Manages contracts to ensure adequate study activity scope and budget, identify out of scope activities, and support development of change orders, revised budgets, and impact assessments. - Develop and maintain effective stakeholder communication across functions including Toxicology, Formulation/CMC, Clinical Development, Regulatory, Clinical Pharmacology, Biometrics, Biomarkers and other technical disciplines to ensure seamless program execution. Informs (as appropriate) on overall clinical trial plans, recruitment status, and raises potential issues/mitigation. - Responsible for providing sponsor oversight of clinical study conduct (start-up through database lock and reporting) in compliance with Alector SOPs, FDA/EMA/ other RA regulations, ICH/GCP guidelines and applicable local laws, including review of study documents (protocol, ICF), study presentations, study tools, and study plans (e.g. RBM, IRT, EDC, ePRO, SRM, Recruitment, Laboratory Manuals, etc.) and coordinating cross-functional efforts to achieve study objectives with a focus on quality. Drives study execution utilizing available performance metrics and quality indicators and study milestones and drivers. - Provide oversight of activities associated with the implementation, management and monitoring of clinical trials including but not limited to review of monitoring reports, site recruitment, attrition effort. Oversees data discrepancy management and assists mapping as needed with routine review of risk management plans, protocol deviations lists, ongoing data cleaning, listing review and TLFs (when available). Provides input/reviews clinical study report and appendices, DSUR, and regulatory annual and periodical reports. - Work with QA to review contract service providers and perform audits as required - Responsible for clinical trial material (CTM) label review and approval and assisting with CTM forecasting for studies - May participate in company initiatives, company policies/procedures, continuous improvement initiatives, and shares knowledge where applicable. - May require travel up to 15%. - The role is expected to grow as portfolio advances. - Champion and embrace the thoughtful adoption of innovative technologies, including AI-enabled tools and large language models, to improve planning, decision-making, and operational efficiency while accelerating development programs and maximizing organizational resources! ### You will be successful at this role if you: - Bachelor’s Degree or Graduate Degree in a field of science or nursing, preferably biology, chemistry, pharmacy or other field related to human study. PMP certification is preferred - Minimum of 8+ years of relevant and progressive clinical trial management experience and proven track record of successful management of global clinical research studies (Phase 1b/2/3) and timeline fulfillment including at least 3 years of project management experience supporting drug development programs. - Deep knowledge of FDA and EMA drug development and clinical trial regulations (21 CFR Parts 11,50,54,56, 312 and 312 and ICH/GCP/GDPR) - Experience selecting, qualifying and overseeing CROs/vendors/consultants - Working knowledge of data management, data review and analysis activities, as well as drug safety and pharmacovigilance reporting requirements. - Software proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, MS Project, Teams), Smartsheet, and document sharing sites (e.g. SharePoint) - Experience with electronic quality, compliance, EDMS and CTMS systems - Highly desired to bring a strong understanding of neuroscience drug development processes from clinical-stage programs to the job. - Are influential without formal authority and build trusted relationships across scientific and business functions. - Pride yourself on your organizational, facilitation, communication, and strategic planning skills with exceptional attention to detail. - Thrive in a dynamic, fast-growing biotechnology environment where priorities evolve and ambiguity is expected. Large companies, overbuilding, and red tape are not for you. Flexibility and efficiency are highly valued here. - Actively use of large language models (LLMs) and enthusiastic about leveraging emerging AI technologies to improve productivity, collaboration, and project execution. Productivity, streamlining, and adopting new technologies to support these goals are core to your personal working ethos.