Senior Director, Clinical Operations

Company Summary: Atavistik Bio is focused on unlocking hidden functional pockets to discover transformative allosteric precision therapeutics to address serious unmet patient needs. By integrating our propriety screening technology using the body’s natural regulators, with our powerful AI-enabled drug discovery platform, we are able to efficiently identify novel, biologically relevant allosteric sites for protein or RNA targets, and rapidly advance structural insights into small molecule therapeutics design. Atavistik is advancing multiple high value oncology programs and anticipates initiating clinical development in early 2025. Atavistik is based in Cambridge, MA and backed by leading biotech venture capital firms The Column Group, Nextech and Lux Capital. Position Summary: The Senior Director, Clinical Operations is responsible for the operational efforts of shaping our clinical programs and building our clinical operations function. You will work closely with a cross-functional team in a fast-paced environment to ensure clinical trials are appropriately supported by internal and external stakeholders, conducted on time and budget, and in accordance with applicable guidelines and regulatory requirements. Key Responsibilities:

• Accountable for and manages and drives excellence in the overall clinical operational activities for multiple clinical studies, including close collaboration with and oversight of clinical research organizations (CROs) and other external partners
• Provides functional expertise for Clin Ops strategies and tactical implementation of the studies by managing timelines and deliverables
• Lead preparation of vendor requirements and project scope and support selection of and contracting with CROs and clinical study vendors, and in turn, clinical study budget development, forecasting and tracking
• Implement appropriate systems, standards, and processes to ensure quality in study execution with our investigator sites, CROs, and other clinical trial vendors
• Oversees the operational aspects for the development and delivery of standard study protocols, informed consents, vendor selection/management, site/country selection, etc
• Ensures oversight and study-specific Risk Management Plans (RMP) (e.g., milestones, metrics, and critical path), ensuring appropriate escalation when required. Evaluate study-level issues for broader impact (e.g., cross-study, cross-program, etc.) and ensure resolution
• Oversee ongoing and timely data analysis to ensure on-time availability of clinical study results and data integrity
• Set up and implement effective investigator and site monitor training; facilitate operational and disease area training for internal and external stakeholders as required to support high quality study execution.
• Develops site recruitment, enrollment, and engagement strategies for all clinical trials
• Review and approve study invoices and participate in accrual reviews with Finance, and external vendors
• Responsible for establishing and updating clinical operations SOPs, Work Instructions, guidelines, standards, and best practices
• Provide Senior Management with timely updates on progress (including any changes in scope, schedule, and resources across the program)
• Depending on experience, may contribute to or be primarily responsible for formulation of a Clinical Development Plan (CDP)
• Collaborates with cross functional team members to prepare strategy presentations, present and discuss data at relevant meetings, external consultants, KOLs and potentially regulatory meetings as well as author sections of regulatory documents (IB, Annual Reports, IND sections, CSR). Must have proven scientific writing skills and good communication skills
• Ensures effective communications to internal and external stakeholders through meetings, presentations, and other methods. Manages content, agenda, and discussions at clinical operations sub-teams and ensures action items are closed
• Participates in resource prioritization to ensure department and corporate goals and milestones are achieved
• Collaborates with Clinical Quality Assurance to develop a strategic plan for CRO and vendor audits
  
  
  

Qualifications:

• Bachelor’s degree required; scientific background / RN is a plus.
• 15 years of clinical research experience, including working directly with CROs to manage clinical trials within the pharmaceutical/biotech industry; experience in precision oncology is a plus
• Excellent understanding of ICH and GCP guidelines, as well as applicable regulations and industry best practice
• Excellent organizational skills and attention to detail; willing to operate deep in the details and in a fast-paced environment.
• Effective communication and interpersonal skills
• Able to distill complex matters into a clear business case and roadmap for execution
• Strong project management skills with a high sense of urgency
• Capable of setting and managing multiple competing priorities which evolve over time
• Proven ability to effectively execute clinical trials within designated program budgets, timelines, and compliance guidelines
• Comfortable working closely with a team of external consultants and hiring to build out Clinical Operations team as our programs progress.
• Ability to travel as needed