Note: The job is a remote job and is open to candidates in USA. Alector is seeking an Associate Director of Clinical Project Management to lead end-to-end operational delivery of assigned clinical trials across its product development portfolio. The role leads cross-functional study teams and external partners, overseeing study plans, timelines, budgets, risks, compliance, and execution from initiation through closeout.
Responsibilities
- 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
- 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!
Skills
- Bachelor's Degree or Graduate Degree in a field of science or nursing
- 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
- 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
- Preferably biology, chemistry, pharmacy or other field related to human study
- PMP certification is preferred
- Highly desired to bring a strong understanding of neuroscience drug development processes from clinical-stage programs to the job
Benefits
- Flexible hybrid work options
Company Overview
Company H1B Sponsorship