Erasca, Inc.

Clinical Research

• Manage or assist in the management of large global oncology clinical trials (Phase 1-3), ensuring that studies are carried out in accordance with the protocol, ICH GCP, and local regulatory requirements.
• Support key study-related activities and deliverables.
• Support implementation of training programs ensuring relevant employees are trained as needed to ensure compliance with the protocol and other study-related documents.
• Track study progress and maintain study status updates (e.g., site selection, IRB approvals, regulatory document collection, enrollment, SDV status, study drug inventory, clinical specimen tracking).
• Provide progress updates to relevant project teams and present a plan of action for resolution of issues (e.g., trial issues, investigator/study coordinator feedback, monitoring issues, patient enrollment issues).
• Maintain and support the eTMF and CTMS platform for clinical studies and operational workflows.
• Manage user accounts, permissions, roles and eTMF/CTMS access.
• Monitor eTMF/CTMS system performance, trouble shoot issues, and coordinate resolutions with vendor and/or study team members.
• Support eTMF/CTMS system upgrades, patches, testing, and validation activities.
• Maintain TMF structure and index according to ICH-GCP and Erasca SOPs.
• File, classify, and index documents into the eTMF.
• Perform ongoing review of trial TMF(s) to assure quality and compliance with relevant SOPs and ICH-GCP.
• Track, triage, and resolve missing or nonconformant documents. Collaborate with study team members to obtain required documents and ensure timely filing.
• Prepare and support regulatory and sponsor inspections/audits (document retrieval, audit trails, and corrective actions).
• May conduct (co)monitoring visits (pre-study, initiation, monitoring, and closeout) with contracted monitors/CRO.
• Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations.

Associate Clinical Trial Manager

Vice President

• Provide medical direction and high-quality scientific and clinical knowledge to guide the strategy and execution of late-stage clinical programs and contribute to clinical decision making across the Erasca portfolio.
• Lead late clinical development function, directly and through reports.
• Responsibilities include clinical development strategy, protocol development, registrational strategy, KOL and academic site interactions, competitive landscape diligence, presentation of data, and other clinical deliverables.
• Serve as Medical lead on clinical programs and represent Clinical Development on program teams.
• Design and implement novel and efficient registration enabling clinical trials to assess appropriate endpoints.
• Responsible for leading clinical study subteams, monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data.
• In collaboration with head of Medical Affairs, continue the establishment and execution of medical affairs strategy and tactics.
• Contribute to regulatory filings including authoring clinical sections for NDAs and other related documents.
• Partner with Drug Safety to assess the safety profile of compounds.
• Write medical aspects of core study and regulatory documents including clinical research plans, protocols, investigator brochures, clinical study reports and regulatory submissions.
• Contribute to the development and review of scientific publications; author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives.
• Present at scientific, medical, and regulatory meetings.
• Maintain a high level of clinical and scientific expertise by reviewing literature, attending medical or scientific meetings, and through personal exchange with thought leaders, investigators, and internal stakeholders and partners.
• Participate in due diligence or other business development activities.
• Recruit, retain, and develop high-functioning late clinical development team.
• Establish, develop, and maintain relationships across Erasca, particularly with partners and stakeholders in Research and Development.
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.

Associate Clinical Trial Manager

SVP Late Clinical Development