AVENZO THERAPEUTICS INC

Role Description Reporting to the Senior Director, Data Management, the Associate Director, Clinical Data Management (CDM) Programmer will lead and oversee clinical data management activities across our clinical programs, ensuring the delivery of high-quality, compliant, and timely clinical trial data. This role serves as a hands-on leader and subject matter expert, partnering closely with Clinical Development, Biometrics, Medical, Regulatory, and external vendors to support decision-making and regulatory submissions. - Lead and oversee end-to-end clinical data management activities across assigned clinical programs, from study start-up through database lock and study close-out. - Define programming strategy, standards, and best practices for inspection-ready deliverables, including edit checks, derivations, custom functions, and automated data review tools. - Generate data listings, reconciliation outputs, and other programmed deliverables to support clinical data management and biostatistics. - Direct the design, development, validation, and oversight of clinical data capture systems, ensuring data integrity and effective Contract Research Organization (CRO) oversight. - Oversee database build, User Acceptance Testing (UAT), data cleaning, medical coding, and database lock activities, ensuring timelines and quality expectations are met. - Serve as the clinical data management subject matter expert and study-level lead on cross-functional teams, partnering closely with Clinical Development, Biometrics, Clinical Operations, Medical, Regulatory, Quality, and Compliance. - Apply risk-based data management and quality oversight methodologies to proactively identify, assess, and mitigate data-related risks. - Manage CROs and external data vendors, including scope definition, performance monitoring, and issue escalation/resolution. - Ensure data management processes, documentation, and vendor deliverables comply with applicable regulations and standards (e.g., ICH-GCP, 21 CFR Part 11, GCDMP). - Support inspection readiness and participate in audits and regulatory inspections as required. - Develop and maintain reusable programming assets (e.g., SAS macros) and automated outputs (listings/tables/visualizations) to support ongoing and ad hoc data review. - Provide technical leadership and guidance on clinical database structure, data standards, and downstream data use to internal teams and external vendors. - Ensure all programming outputs meet CDISC standards (e.g., SDTM/ADaM) and regulatory expectations. - Maintain study-level data management documentation in an audit-ready state and oversee quality-controlled filing within the electronic Trial Master File (eTMF). - Proactively identify issues impacting study timelines, milestones, or data quality and implement effective mitigation strategies. - Contribute to the development, implementation, and continuous improvement of Clinical Data Management SOPs, standards, and best practices. - Support Clinical Operations, Biostatistics, and Data Management by providing data insights and solving complex technical and programming challenges. Qualifications - Bachelor’s degree in Life Sciences or Computer Science required, or a related area degree preferred (e.g., MBA) with 10+ years of progressive Clinical Data Management experience in the life sciences industry or an equivalent combination of academic and industry experience. - Proficiency in SAS programming; experience with SQL, R, or Python is an advantage. - Strong understanding of clinical data management processes, including EDC design, data cleaning, query management, and database lock procedures. - Hands-on experience with CDISC standards (CDASH, SDTM) and data readiness for regulatory submissions. - Recognized for consistently delivering high-quality programming outputs, mentoring junior programmers, and improving CDM processes through automation and standardization. - Proficient with various data collection and Electronic Data Capture (EDC) systems. - Experience managing CROs and external vendors in a sponsor oversight mode. - Strong knowledge of clinical research, regulations and industry standards (e.g. FDA/ICH, ICH-GCP, 21 CFR Part 11, GCDMP). - Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders. - Strong analytical and problem-solving abilities, with a strategic mindset. - Promote knowledge sharing, documentation, and consistent application of programming standards. Requirements - This position requires periodic/regular travel, including up to 10% of work time, which may include overnight travel. Benefits - Employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance. - Additional benefit programs include short-term and long-term disability insurance, flexible spending accounts, health savings accounts, and voluntary insurance programs, including voluntary life, AD&D accident, and critical illness. - Employees will also be able to enroll in the Company’s 401(k) plan. - Employees will accrue 10 hours of paid vacation time every month and accrue 1 hour of paid sick leave for every 30 hours worked. - Employees enjoy 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies.

Role Description The Senior Director, Regulatory Affairs will have the opportunity to shape both program-level strategy and the evolving regulatory function within a dynamic, mission-driven organization. This individual will be responsible for primary authorship and supporting regulatory activities, preparing regulatory submissions and ensuring compliance with global regulatory requirements. - Develop and execute U.S. and global regulatory strategies for one or more solid tumor oncology programs across the clinical development lifecycle, aligned with corporate and program objectives. - Serve as the Regulatory Affairs lead on cross‑functional program teams, providing regulatory guidance to Clinical, CMC, Biometrics, Pharmacovigilance, Quality, and other stakeholders. - Lead the strategic planning, review, and execution of regulatory submissions and maintenance activities (e.g., INDs, CTAs, amendments, briefing packages, and, as applicable, BLAs/MAAs), ensuring compliance with global regulatory requirements. - Assess and pursue oncology-specific expedited programs and designations, including Fast Track, Breakthrough Therapy Designation, Orphan Drug Designation, Accelerated Approval, and EMA PRIME, as appropriate for solid tumor indications. - Lead and coordinate health authority interactions, including meeting strategy, preparation and oversight of briefing documents, responses to requests for information, and management of post‑meeting commitments. - Conduct regulatory risk assessments and gap analyses; identify potential issues and develop mitigation strategies to support successful regulatory outcomes. - Provide regulatory leadership in the assessment of emerging clinical data and operational activities, evaluating regulatory impact and advising on strategy adjustments as needed. - Contribute to and/or lead the development and review of key regulatory documents, including clinical protocols and clinical and nonclinical study reports. - Drive high‑quality execution of regulatory deliverables, including alignment of timelines, content consistency across documents, and adherence to internal standards and best practices. - Translate evolving global regulatory guidance and regulatory intelligence into actionable recommendations for program teams and senior leadership. - Support the growth and scalability of the Regulatory Affairs function through process improvement, cross‑functional alignment, and mentoring of internal team members and external partners, as appropriate. - Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders. - Strong analytical and problem-solving abilities, with a strategic mindset. - This position requires periodic/regular travel, including up to 10% of work time, which may include overnight travel. Qualifications - Bachelor’s degree required, advanced medical or life sciences or a related area degree preferred (e.g., MS, Ph.D.) with 12+ years of regulatory affairs experience in the life sciences industry or an equivalent combination of academic and industry experience. - Direct experience supporting early-stage (pre-IND to Phase 1/2) solid tumor oncology programs. - Familiarity with multiple oncology modalities (e.g., small molecules, biologics, ADCs). - Demonstrated ability to develop, lead, and implement global regulatory strategies for complex development programs across multiple phases of the product lifecycle. - Extensive knowledge of U.S. and international regulatory requirements, including FDA and EMA regulations, guidance, and industry standards applicable to oncology development programs. - Proven experience leading major regulatory submissions and global filing activities (e.g., INDs, CTAs, and, as applicable, BLAs, MAAs, NDAs/NDSs). - Demonstrated success leading regulatory interactions with health authorities, including briefing package development, response strategy, and negotiation of regulatory positions and commitments. - Strong track record of independent decision‑making, regulatory risk identification, and development of mitigation strategies affecting program and portfolio outcomes. - Demonstrated ability to influence and lead cross‑functional teams in a matrix environment, providing strategic regulatory guidance to Clinical, CMC, Biometrics, Pharmacovigilance, and related functions. - Strategic thinker with strong analytical judgment, problem‑solving skills, and the ability to thrive in a fast‑paced, evolving biotech environment. - Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders. - Strong analytical and problem-solving abilities, with a strategic mindset. - This position requires periodic/regular travel, including up to 10% of work time, which may include overnight travel. Benefits - Eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance. - Additional benefit programs include short-term and long-term disability insurance, flexible spending accounts, health savings accounts, and voluntary insurance programs, including voluntary life, AD&D accident, and critical illness. - Enrollment in the Company’s 401(k) plan. - Accrue 10 hours of paid vacation time every month and accrue 1 hour of paid sick leave for every 30 hours worked. - Enjoy 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies.

Role Description Reporting to the Executive Director, Clinical Science, the Associate Director, Clinical Science will provide scientific and clinical support for the design, conduct, analysis, and reporting of clinical trials. This role contributes hands-on clinical expertise across study teams while collaborating closely across the organization to ensure high-quality scientific execution. - Represent Clinical Sciences on study teams and sub-teams by providing clinical input, addressing relevant questions, and communicating study progress and emerging data, as needed. - Support study oversight with Clinical Operations, ensuring protocol adherence and subject safety. - Develop and review site and Clinical Research Associate (CRA) training materials, present at Site Initiation Visits (SIVs) and Investigator Meetings (IV), and support activities of Safety Review and Data Monitoring Committees. - Provide clinical input to support the development of trial budgets, CRO scopes of work, and related materials, in collaboration with Clinical Outsourcing and Operations. - Collaborate with internal Clinical Operations, Data Management, Biostatistics, Safety, and Regulatory groups to support scientific and operational execution of the clinical protocol. - Conduct ongoing clinical data review and support data exploration to identify trends, patterns, and potential safety or efficacy signals. - Perform clinical review of trial data for safety and efficacy, assessing consistency and completeness, and provide preliminary interpretations and recommendations to the team. - Participate in cross-functional clinical data review meetings and support study closeout activities, including data archiving and contributions to clinical study reports. - Contribute to clinical development activities under the guidance from senior Clinical Science or Clinical Development leaders. - Review and contribute to the authoring of study protocols, study-related documents, and clinical sections of regulatory documents (e.g., INDs, Investigator’s Brochure [IB], DSURs, regulatory responses, case report forms), ensuring consistency and scientific accuracy. - Collaborate with Pharmacovigilance function by supporting clinical review of safety narratives and other safety-related documents and participate in internal safety discussions as needed. - Support the Medical Monitor and development team in interactions with study investigators and clinical subject matter experts. - Develop and review clinical narrative plans and individual clinical narratives as assigned. - Review scientific literature and competitive intelligence to support study and program activities. - Develop scientific and clinical presentations for internal and external meetings, and present as needed (e.g., investigator meetings, site visits, and internal review meetings). - Contribute to abstracts, posters, and other scientific meeting materials, including supporting internal review and submission processes as needed. - Participate in discussions related to the design and development of early- and late-stage studies, providing clinical science input as needed. Qualifications - Bachelor’s degree required, advanced medical or life sciences or a related area degree preferred (e.g., MS, Ph.D., MPH, PharmD) with 8+ years of experience in the life sciences industry or an equivalent combination of academic and industry experience. - Experience conducting clinical data listing reviews and demonstrating familiarity with standard clinical and regulatory references (e.g., CTCAE, MedDRA). - Working knowledge of principles and techniques of clinical data analysis and interpretation. - Experience reviewing and contributing to clinical study protocols and related documents. - Knowledge of GCP (Good Clinical Practice), ICH, FDA, EMA, and other relevant guidelines and regulations. - Proven ability to collaborate within cross-functional teams. - Ability to understand and assimilate complex scientific and clinical information. - Demonstrates initiative, strong organizational skills, and attention to detail. - Proficiency in Microsoft Word, Excel, PowerPoint, and Electronic Data Capture systems (e.g., RAVE), J-Review, or similar data review tools. - Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders. - Strong analytical and problem-solving abilities, with a strategic mindset. - This position requires periodic/regular travel, including up to 20%, which may include overnight travel. Benefits - Employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance. - Additional benefit programs include short-term and long-term disability insurance, flexible spending accounts, health savings accounts, and voluntary insurance programs, including voluntary life, AD&D accident, and critical illness. - Employees will also be able to enroll in the Company’s 401(k) plan. - Employees will accrue 10 hours of paid vacation time every month and accrue 1 hour of paid sick leave for every 30 hours worked. - Employees also enjoy 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies.