Erasca, Inc.

Role Description Reporting to a Sr. Clinical Project Manager of Clinical Operations, the Associate Clinical Trial Manager (aCTM) will assist in the implementation and conduct of clinical research projects and provide support for project teams. The position requires knowledge of clinical trial processes and experience in many aspects of trial execution from study start-up to close-out, including assisting in the management of clinical vendors or CROs and assisting in the oversight of resources, budgets, contracts, and timelines. The aCTM will also manage the oversight of the CRO’s TMF activities, including maintenance and quality control of Trial Master File documents. - 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 for clinical studies and operational workflows. - Manage user accounts, permissions, roles and eTMF access. - Maintain TMF structure and index according to ICH-GCP and Erasca SOPs. - Review the CRO’s work filing, classifying, and indexing documents into the eTMF. - 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. Qualifications - Preference for undergraduate degree in Biological Sciences or professions (pharmacy, medicine, nursing, or other allied health sciences) with a minimum of 1-2 years of relevant experience. - At least 1-2 years of experience in clinical operations in pharmaceutical company or CRO including trial set-up, monitoring, and close-out of US and non-US trials at all phases of pre-NDA clinical research (Phases 1-3). - 1-2 years experience in TMF/document management or clinical trial support. - Experience with eTMF systems (e.g. Trial Interactive eTMF, Veeva Vault). - Demonstrated track record of successfully supporting multiple projects, trials, and priorities. - Experience with managing study vendors (e.g., CRO, IRT/IXRS, central laboratories, eTMF/CTMS) preferred. - Practical knowledge and implementation of ICH-GCP guidelines and US and ex-US regulations. - Ability to work well with global, multi-disciplinary teams. - Must be a self-starter able to thrive in an entrepreneurial, fast paced, and dynamic work environment. - Must be organized with excellent oral and written communication skills. - Strong learning orientation, curiosity, and commitment to science and patients. Requirements - The anticipated salary range for this position is $122,000 to $137,000. - The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. - In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price. Benefits - Paid Time Off, Holiday, and Sick Leave - Medical, Dental and Vision Plans - Short- and Long-Term Disability - Basic and Voluntary Life/AD&D Coverage - Flexible Spending Accounts (FSA, HSA, and Commute) - Critical Illness and Accident Coverage - Pet Insurance - Employee Assistance Program - 401(k) Plan with Erasca contribution - Opportunity to participate in an Employee Stock Purchase Program Company Description Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex, race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.

Role Description Reporting to the Executive Director, CMC Regulatory Affairs, the Senior Manager or Associate Director of CMC Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA development and maintenance for support of new and ongoing clinical trials, as well as planning for future MAA/NDA/BLA(s). This role requires an independent, self-directed, and highly motivated regulatory professional. - Deliver CMC regulatory support through QC review of submission components, including CMC documents, labeling, application forms, supporting GMP documentation, cover letters and verification of submission links, ensuring completeness, consistency, and compliance with regulatory requirements. - Prepare and/or review CMC regulatory documents and submissions to support product development (e.g. ND/CTAs, DSUR, health authority briefing document, iPSP/PIP, NDA/MAA). - Provide oversight of regulatory submission content and planning, to assure technical accuracy, compliance, and completeness. - Assess proposed CMC changes (e.g., manufacturing processes, analytical methods, specifications, manufacturing sites, container closure systems, stability programs, and suppliers) and support development of appropriate global regulatory filing strategies. - Collaborate cross-functionally on the eTMF processes and compliance alignment. - Represent regulatory on study and program teams throughout study conduct and product development. - Support or lead development of global regulatory submissions, including requests from regulatory authorities relating to clinical trials, and responses to health authority requests for information, as required. - Review relevant clinical and CMC documents (protocol, informed consent form, investigator’s brochure, and site quality documentation, and required regulatory forms) for regulatory compliance and consistency across submission components. - Maintain current knowledge of US and international CMC regulation requirements that apply to company products and processes. - Support or lead development of internal Erasca SOPs and processes, as needed. - May support other global submission activities as appropriate, independently or in collaboration with the Regulatory Affairs project lead. - Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations. Qualifications - Undergraduate degree required; advanced degree preferred. - 5+ years of experience in pharmaceutical or biotech regulatory affairs or related areas, including regulatory affairs for oncology products. - Ability to translate regulatory requirements into practical workable plans. - Diverse experience with regulatory activities including creation of systems and processes to support efficient and high quality submission of documents to regulatory bodies. - Strong organizational skills that reflect the ability to perform and prioritize multiple tasks with excellent attention to detail. - Ability to build strong relationships with co-workers of various backgrounds and expertise. - Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment. - Effective interpersonal and communication skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems. - Strong learning orientation, curiosity, and commitment to science and patients. Requirements - The anticipated salary range for this position is $175,000 to $205,000. - The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. - In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price. Benefits - Paid Time Off, Holiday, and Sick Leave - Medical, Dental and Vision Plans - Short- and Long-Term Disability - Basic and Voluntary Life/AD&D Coverage - Flexible Spending Accounts (FSA, HSA, and Commute) - Critical Illness and Accident Coverage - Pet Insurance - Employee Assistance Program - 401(k) Plan with Erasca contribution - Opportunity to participate in an Employee Stock Purchase Program Company Description Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name “Erasca” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer.

• Manage global clinical trials (Phase 1-3) in oncology indications, ensuring that studies are carried out in accordance with the clinical development plan, ICH-GCP, and FDA/other regulatory agency requirements. • Recruit global study sites and foster relationships with study investigators. • Participate in the process of site and vendor selection, qualification, and activation. • Develop Requests-for-Proposals and assist in vendor selection efforts. • Assist in review and negotiation of vendor contracts and study site clinical trial agreements. • Manage study vendors (e.g., CRO, IRT, laboratories, core ECG/imaging). • Monitor the progress of trials, including enrollment and clinical trial material inventory. • Review monitoring visit reports for completeness and adherence to the annotations. • Assist in packaging/labeling/distribution of clinical trial material. • Monitor and track biological samples for applicable analyses. • Provide progress updates to management and during program team meetings. • Assist in departmental budgeting, including accruals and projections. • Assist in development of protocols, consent forms, IRB/EC materials, and other trial documents. • Assist in development of Clinical SOPs. • Prepare/review/approve study materials such as CRFs, patient diaries, drug accountability forms, study and investigator manuals, project plans, and monitoring reports. • Assist in electronic case report form design and development. • Assist in IRT design and development. • Participate in data cleaning activities and developing appropriate data outputs. • Understand and help fulfill the needs of other Erasca departments (e.g., Finance, Research). • Provide leadership and mentoring of other Clinical team members. • Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.

• 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.

Role Description Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Reporting to the Chief Medical Officer, the SVP Late Clinical Development will provide medical leadership and oversight of late-stage clinical trials and collaborate with the CMO across the Erasca portfolio. A key area of focus will be the design and execution of multiple registration enabling trials in solid tumor indications. - Provide medical direction and high-quality scientific and clinical knowledge to guide the strategy and execution of late-stage clinical programs. - Participate in building and maintaining a culture of rigorous data-driven decision making. - Lead late clinical development function, directly and through reports. - Responsibilities will include: - Clinical development strategy - Protocol development - Registrational strategy - KOL and academic site interactions - Competitive landscape diligence - Presentation of data - 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. Qualifications - M.D. degree or equivalent, with subspecialty fellowship training and board certification or eligibility in Oncology or Oncology/Hematology. - 12+ years of oncology clinical trial and drug development experience, including extensive experience in the pharmaceutical or biotechnology industry. - Direct management of medical and scientific staff in clinical development required; experience leading medical affairs function highly preferred. - Experience as the clinical lead on complicated global programs with multiple indications and studies required. - Experience leading or being closely involved in the clinical aspects of a regulatory filing and direct interaction with health authorities required. - Experience with product launch and commercialization highly preferred. - Experience in early development a plus. - Extensive knowledge of clinical trial methodology and the regulatory and compliance requirements governing clinical trials. - Executive leadership skills to represent late development on LT, educate and influence stakeholders, and add value in strategic business planning and decision-making. - Demonstrated ability to collaborate successfully with multiple functions in a matrixed team environment. - Effective interpersonal, communication and influencing skills, including excellent writing skills. - Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment. - Strong learning orientation, curiosity, and commitment to science and patients. Requirements - The anticipated salary range for this position is $400,000 to $465,000. - The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. - In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price. Benefits - Paid Time Off, Holiday, and Sick Leave - Medical, Dental and Vision Plans - Short- and Long-Term Disability - Basic and Voluntary Life/AD&D Coverage - Flexible Spending Accounts (FSA, HSA, and Commute) - Critical Illness and Accident Coverage - Pet Insurance - Employee Assistance Program - 401(k) Plan with Erasca contribution - Opportunity to participate in an Employee Stock Purchase Program Company Description Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex, race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.

• Reporting to the Chief Medical Officer, the SVP Biometrics will be accountable for biometrics activities for all programs from IND-enabling to registration and launch. • This includes leadership of the Biostatistics, Statistical Programming & Analysis, and Clinical Data Management functions. • This role requires hands-on execution as well as oversight of internal and external staff. • In addition, this person will represent the Biometrics function on the Erasca leadership team and in cross-functional discussions and decision making. • Build, maintain, and develop a high performing team across Biostatistics, Statistical Programming, and Clinical Data Management. • Ensure systems, capabilities and resources are in place that optimize the design, conduct, analysis and interpretation of clinical and nonclinical data for all programs. • Demonstrate technical excellence, delivering advanced biometric strategies across the portfolio. • Act as the subject matter expert for biometrics, advising senior management, development, and clinical operations teams on current biostatistics methodology and tools in drug development. • Collaborate with VP, Biostatistics, to ensure statistical analysis and submission datasets meet regulatory requirements. • Collaborate with VP, Statistical Programming & Analysis, to ensure the intended analyses are performed, and analysis data sets and their specifications are in place. • Collaborate with Sr Director, Clinical Data Management, to provide support to clinical study teams on the collection, interpretation and reporting of clinical data. • Provide input on key development documents, clinical protocols, study reports, IBs, INDs, NDAs, and labeling for all products. • Support preparations for interactions with regulatory agencies and provide guidance to ensure high quality preparation of Regulatory Authority documents.