Candel Therapeutics

Title: Associate Director, TMF Operations Location: Needham, MA Job Description: Full Time Manager/Supervisor Salary: $184-$210k + bonus + options + benefits Hybrid role- 2-3 days in Needham office Why Work With Us? At Candel, our people drive our success. We value diversity, collaboration, and bold thinking in a supportive, mission-driven environment. Like a team, we show up for each other and stay focused on making a difference for patients and families. Our leadership is transparent and empowering, and our culture is built on trust, flexibility, and accountability, encouraging ownership and innovation every day. Our Science: Advancing Cancer Immunotherapies Candel is a clinical-stage biopharma company developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses. Our platforms use genetically modified adenovirus and HSV constructs. With positive Phase 3 results for our lead candidate, it’s an exciting time to join us and help bring transformative cancer treatments to patients. Learn more: www.candeltx.com Position Summary: We’re looking for an experienced Associate Director, Trial Master File (TMF) Operations to lead the Trial Master File operations across our oncology clinical programs. This role is ideal for someone who enjoys creating structure in a fast-paced biotech environment and can confidently partner across Clinical Operations, Quality, Regulatory, IT, and external vendors to ensure inspection readiness and operational excellence. You’ll play a critical role in strengthening TMF strategy, oversight, quality, and reporting infrastructure while helping build scalable processes that support a growing clinical portfolio. This is a highly visible opportunity for someone who combines strategic thinking with hands-on execution and enjoys driving continuous improvement. What You’ll Do: • Lead TMF operational strategy and help build scalable, inspection-ready processes across ongoing and future clinical studies • Drive oversight of electronic TMF activities to ensure quality, completeness, accuracy, and regulatory compliance across internal teams and external partners • Develop and refine TMF standards, governance models, workflows, and procedural documentation aligned with industry best practices and global regulations • Act as a trusted TMF subject matter expert and strategic partner to Clinical Operations leadership and cross-functional stakeholders - Management of the eTMF system vendor • Establish and monitor TMF health metrics, dashboards, and operational KPIs to identify trends, risks, and opportunities for improvement • Conduct TMF reviews, quality assessments, and operational audits to ensure inspection readiness at all times • For outsourced studies, partner closely with CROs and vendors to ensure deliverables, timelines, expectations, and performance standards are consistently met • Support implementation, optimization, and integration of TMF-related systems and technologies including eTMF platforms, CTMS, EDC, and other clinical systems • Collaborate with IT and business stakeholders on system enhancements, upgrades, validation activities, and change management initiatives • Help drive operational excellence by identifying process gaps, improving workflows, and creating sustainable solutions that support organizational growth • Provide training and guidance to internal teams on TMF processes, expectations, and best practices • Support clinical trial disclosure and registry compliance activities in partnership with cross-functional teams What You Bring: • Bachelor’s degree in a scientific, healthcare, or related discipline, or equivalent industry experience • 10+ years of clinical research experience within biotech, pharmaceutical, or CRO environments • Strong background in TMF operations, document management, and inspection readiness activities • Hands-on experience managing eTMF systems and TMF reporting processes • Deep understanding of ICH-GCP requirements, TMF best practices, and global regulatory expectations • Experience working collaboratively with CROs, vendors, and cross-functional stakeholders in a matrixed environment • Ability to operate effectively in a growing biotech company where priorities may evolve quickly • Strong organizational skills with the ability to manage multiple priorities while maintaining exceptional attention to detail • Excellent communication, collaboration, and problem-solving skills • A proactive mindset with the ability to work independently, influence others, and drive initiatives forward Work Environment: • Hybrid role based in Needham, MA • Regular onsite collaboration expected approximately 2–3 days per week depending on business needs • Occasional travel may be required to support audits, inspections, vendors, or cross-functional meetings You must be authorized to work in US. We are unable to provide any sponsorship at this time. NOTE: We are not allowing agencies at this time.

Title: Clinical/Commercial Supply Chain Senior Manager- CONTRACT Location: Needham, MA Job Description: Clinical/Commercial Supply Chain Senior Manager- CONTRACT - Hybrid role (3 days a week) Needham, MA - Contract until December 31,2026 - Salary: $160-$180k annualized Position Overview We are seeking a talented, self-driven, and highly motivated Clinical/Commercial Supply Chain Manager/Senior Manager with deep expertise in supply chain management. This role is responsible for overseeing the end-to-end supply of Clinical Trial Materials (CTM) across all stages of clinical development, as well as commercial operations in the future, including packaging, labeling, and distribution. The position will also serve as a key partner to Clinical Operations, Regulatory, Quality, and clinical sites, providing guidance on all aspects of CTM, comparators, and supplemental products, as applicable.Key Responsibilities - Support clinical/commercial supply activities for ongoing and new clinical trials or commercial launch to ensure on-time delivery, including demand forecasting, trial monitoring, resupply planning, IRT or inventory system setup, and distribution. - Lead the design and execution of packaging and labeling campaigns, including timeline management, documentation review/approval, and coordination with Contract Development and Manufacturing Organizations (CDMOs). - Manage CDMO relationships and provide comprehensive oversight of clinical or commercial supply activities. - Ensure uninterrupted supply of clinical trial materials for studies across U.S. and international (ex-U.S.) sites. - Support timely startup of new clinical studies by ensuring availability of required materials. - Oversee and track manual distribution activities to global clinical sites, ensuring on-time delivery. - Develop and maintain efficient processes and tracking tools for manual shipments. - Review clinical protocols and develop appropriate supply chain strategies. - Manage logistics operations, including inventory control, import/export activities, transportation, and third-party warehousing. - Act as a cross-functional liaison for inventory and distribution activities, including scheduling, issue resolution, change management, and vendor oversight. - Drive timelines for bulk manufacturing, packaging, labeling, and final release to meet forecasted demand. - Develop, maintain, and present Supply Chain dashboards to senior leadership. - Partner with Accounts Payable and Legal to ensure timely processing and approval of purchase orders, change orders, and invoices related to CDMOs. - Collaborate effectively with cross-functional teams, including Clinical Operations, Pharmaceutical Sciences, Quality Assurance, and Regulatory Affairs. NOTE: This person must be able to lift 80 to100 lbs as this will be a requirement on handling shipments.Preferred Qualifications - Bachelor’s degree with 8-10 years of experience in supply chain planning within the biotechnology or pharmaceutical industry; PMP certification is a plus. - Strong project management, organizational, and communication skills. - Ability to thrive in a fast-paced, innovative environment while remaining flexible, proactive, and resourceful. - Experience managing contract packaging and labeling vendors (strongly preferred). - Knowledge of regulatory requirements for clinical/commercial supply distribution across the U.S., APAC, and EU, including testing and labeling standards. - Experience with cold-chain logistics and shipping validation is a plus. - Solid understanding of cGMP, GCP, GDP, and global transportation regulations for pharmaceutical materials. - Experience working with Qualified Persons (QP), IRT systems, depots, and global CTM distribution. NOTE: This person must be authorized to work in US. We are unable to accommodate any sponsorships.

Salary: $160,000-$200,000 Location: Remote (US) Core hours: Eastern or Central Time Why Work With Us At Candel, our people drive our success. We value diversity, collaboration, and bold thinking in a supportive, mission-driven environment. We are a high-performing team that shows up for each other and stays focused on making a difference for patients and families. Our leadership is transparent and empowering, and our culture is built on trust, flexibility, and accountability—encouraging ownership and innovation every day.Our Science: Advancing Cancer Immunotherapies Candel is a clinical-stage biopharma company developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses. Our platforms use genetically modified adenovirus and HSV constructs. With positive Phase 3 results for our lead candidate, it’s an exciting time to join us and help bring transformative cancer treatments to patients. Learn more: www.candeltx.comPosition Summary The Associate Director, Regulatory Affairs will serve as a regulatory strategist supporting one or more development programs across the product lifecycle, from clinical development through marketing authorization and post-approval maintenance. This is a global role with primary responsibility for developing and executing regulatory strategies that enable efficient multinational clinical development and timely marketing approvals across major markets, including the US, EU, UK, Japan, and other regions. The successful candidate will bring substantial experience navigating the global regulatory landscape for biologics, with demonstrated expertise in late-stage clinical development and ex-US health authority interactions. The ideal candidate will have familiarity with oncology product development as well as the unique regulatory considerations for advanced therapy medicinal products (ATMPs).What You’ll Do Global Regulatory Strategy - Develop, communicate, and execute global regulatory strategies for assigned programs, ensuring alignment across US (FDA), EU (EMA), UK (MHRA), Japan (PMDA) and other target markets. - Lead the preparation of global regulatory submission plans, including sequencing and interdependencies across INDs/CTAs, Orphan Drug Designations, Pediatric Study Plans/PIPs, Breakthrough Therapy / PRIME / Innovation Passport designations, and marketing applications. - Provide regulatory input to clinical development plans, protocol design, and study endpoints, ensuring alignment with health authority expectations and regional requirements. - Advise on regulatory implications of evolving clinical data, including benefit-risk assessment, labeling strategy, and indication scope. - Develop and maintain regulatory risk assessments and mitigation strategies for assigned programs. Ex-US Health Authority Interactions - Develop relationships with expert regional consultants/services for advice and local legal and health authority representation - Serve as a primary Candel regulatory point of contact via regional consultants/services for health authority interactions across multiple regions, including EMA (Scientific Advice, CHMP/CAT interactions), MHRA, PMDA, and other national competent authorities. - Lead preparation of briefing documents, meeting requests, and regulatory correspondence for health authority meetings by managing activities of outside consultants/services. Regulatory Submissions & Operations - Oversee preparation and submission of CTAs across multiple countries, in conjunction with a CROs as applicable, ensuring compliance with regional requirements and timely site activations for multinational clinical trials. - Lead the preparation of ex-US marketing applications (MAAs), including coordination of Module 1 regional requirements and assist in the development of core dossier Modules 2–5. - Ensure consistency and quality of regulatory documents across submissions, maintaining a coherent global regulatory narrative. - Manage regulatory aspects of protocol amendments, safety reporting obligations, and annual reporting requirements across active INDs/CTAs globally. Cross-Functional Partnership & Regulatory Intelligence - Partner with Clinical, CMC, Quality, Research, and Commercial teams to ensure regulatory alignment across all functional deliverables. - Collaborate with CMC regulatory colleagues on integrated regulatory strategy, particularly for programs involving novel manufacturing platforms or ATMP-specific regulatory pathways. - Monitor and interpret evolving regulatory guidance, legislation, and policy across major markets, with particular attention to oncology/immuno-oncology regulatory trends, ATMP/gene therapy frameworks, and expedited development pathways. What You’ll Bring Education: - Bachelor’s degree - RAC certification is a plus Minimum Experience: - 8+ years of progressive experience within the biopharmaceutical industry, with a minimum of 5 years focused in regulatory and a substantial portion in global or international regulatory roles preferred. - Direct experience supporting multinational late-stage (Phase II/III or pivotal) clinical trials, including multi-country CTA submissions and management of region-specific regulatory requirements. - Demonstrated experience working with ex-US health authorities, including EMA (centralized procedure, Scientific Advice, CAT/CHMP interactions), MHRA, Health Canada, PMDA, TGA, or other major regulatory agencies. - Experience with biologics development, including familiarity with the regulatory framework for biological products - Experience working with CROs and regulatory consultants to manage multi-country regulatory filings and health authority interactions - Track record of authoring or leading the preparation of major regulatory submissions (INDs/CTAs, marketing applications, or significant supplements/variations). - Strong working knowledge of ICH guidelines, FDA regulations, EU regulatory framework (Regulation 536/2014, centralized/decentralized procedures), and eCTD format. Additional Preferences: - Direct experience with the preparation and submission of a Marketing Autorisation Application (MAA) through the EMA centralized procudure, including interactions with the rapporteur/co-rapporteur, responses to Day 120/180 questions, and oral explanations. - Experience with gene therapy, cell therapy, or other ATMP products, including familiarity with EMA’s CAT (Committee for Advanced Therapies) review pathway, ATMP classification, and the distinct regulatory considerations for these modalities (e.g., long-term follow-up requirements, conditional marketing authorization, hospital exemption frameworks). - Excellent written and verbal communication skills, with the ability to articulate complex scientific and regulatory concepts clearly and concisely. - Proven leadership and interpersonal skills, with the ability to influence and collaborate effectively with diverse cross-functional teams and external stakeholders. - Strategic thinker with strong problem-solving and decision-making abilities. - Ability to manage multiple projects simultaneously in a fast-paced and dynamic environment. - Proven collaboration with Clinical, Biostatistics, Regulatory, Safety, Research and CMC; consistent milestone and risk tracking with timely issue resolution. - Core working hours will be based in U.S. Eastern Time. The successful candidate must have flexibility to participate in meetings outside of core hours as needed to support collaboration with international teams across Europe and Asia. Applicants must be legally authorized to work in the United States at the time of hire and throughout employment. We are unable to provide, assume, or sponsor work visas or employment authorization for this role now or in the future.

Base Salary: $160,000- $200,000 Location: Remote (U.S.) Core hours: Eastern or Central Time Why Work With Us At Candel, our people drive our success. We value diversity, collaboration, and bold thinking in a supportive, mission-driven environment. We are a high-performing team that shows up for each other and stays focused on making a difference for patients and families. Our leadership is transparent and empowering, and our culture is built on trust, flexibility, and accountability—encouraging ownership and innovation every day. Our Science: Advancing Cancer Immunotherapies Candel is a clinical-stage biopharma company developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses. Our platforms use genetically modified adenovirus and HSV constructs. With positive Phase 3 results for our lead candidate, it’s an exciting time to join us and help bring transformative cancer treatments to patients. Learn more: www.candeltx.com Position Summary The Associate Director/Director, Regulatory Affairs CMC will serve as the CMC regulatory lead for one or more viral vector-based gene therapy programs across the product lifecycle, from preclinical development through clinical trials, marketing application (BLA/MAA), and post-approval lifecycle management. This individual, in collaboration with cross-functional stakeholders, will develop and execute global CMC regulatory strategies, author and review CMC sections of regulatory submissions, and serve as a key liaison with health authorities on manufacturing, analytical, and quality matters. The successful candidate will bring deep expertise in the CMC regulatory landscape for biological products, ideally with hands-on experience in viral vector-based gene therapies (adenovirus, AAV, or other modalities). This role requires the ability to navigate evolving regulatory expectations and to translate complex manufacturing and analytical challenges into sound regulatory strategy. What You’ll Do CMC Regulatory Strategy & Submissions · Develop and execute phase-appropriate global CMC regulatory strategies for assigned viral vector-based gene therapy programs, ensuring alignment with FDA, EMA, and ICH expectations. · Lead preparation, review, and submission of CMC sections for INDs/IMPDs, CTAs, BLAs/MAAs, annual reports, supplements, variations, and health authority responses. · Provide strategic CMC regulatory input to product development plans, including manufacturing process changes, analytical method development, and comparability assessments. Health Authority Interactions · Serve as CMC regulatory representative in health authority meetings (Pre-IND, Type A/B/C, Scientific Advice, PLI readiness). · Prepare CMC module sections, briefing documents, meeting requests, and responses to information requests or clinical holds related to CMC issues. · Monitor and interpret evolving regulatory guidance relevant to viral vector-based gene therapies, including empty/full capsid characterization, potency assay strategies, and process validation expectations. Cross-Functional Collaboration · Partner with manufacturing, analytical development, quality, research, biostatistics and clinical teams to ensure regulatory alignment across CMC activities. · Collaborate with CDMO partners and external regulatory consultants on CMC regulatory deliverables and strategy. · Support due diligence activities for business development and in-licensing opportunities, assessing CMC regulatory risk and readiness. Regulatory Intelligence & Compliance · Maintain current knowledge of global CMC regulatory requirements for gene therapy products, including ICH guidelines (Q5A–Q14), FDA CBER guidance, EMA ATMPs framework, and Ph. Eur. chapters. · Proactively identify regulatory risks and develop mitigation strategies for CMC-related issues such as comparability, low endotoxin recovery (LER), release testing strategy, and supply chain compliance. · Contribute to internal SOPs, regulatory process improvements, and best practices for CMC regulatory operations. What You’ll Bring Education: · Bachelor's degree in a scientific discipline (e.g., Biochemistry, Molecular Biology, Chemistry, Pharmacy, Chemical Engineering) is required. Minimum Experience: · 8+ years of progressive experience in regulatory affairs within the biopharmaceutical industry, with a minimum of 5 years focused on CMC regulatory. · At least 3 years of direct experience with biologics (cell and/or gene therapy products and viral vector-based preferred). · Demonstrated track record of authoring and submitting CMC sections of INDs, CTAs, BLAs/MAAs, or equivalent regulatory filings. · Experience interacting with FDA (CBER/OTP preferred), EMA, or other major health authorities on CMC matters. · Working knowledge of cGMP manufacturing for viral vectors, including upstream/downstream processing, analytical characterization, and release testing. Additional Preferences: · Excellent written and verbal communication skills, with the ability to articulate complex scientific and regulatory concepts clearly and concisely. · Proven leadership and interpersonal skills, with the ability to influence and collaborate effectively with diverse cross-functional teams and external stakeholders. · Strategic thinker with strong problem-solving and decision-making abilities. · Ability to manage multiple projects simultaneously in a fast-paced and dynamic environment. · Proven collaboration with manufacturing, analytical development, quality, research, biostatistics and clinical teams; consistent milestone and risk tracking with timely issue resolution · Ability to work core Eastern or Central U.S. hours (remote, U.S.-based) Applicants must be legally authorized to work in the United States at the time of hire and throughout employment. We are unable to provide, assume, or sponsor work visas or employment authorization for this role now or in the future.

Salary: $160,000-$200,000 Location: Remote (US) Core hours: Eastern or Central Time Why Work With Us At Candel, our people drive our success. We value diversity, collaboration, and bold thinking in a supportive, mission-driven environment. We are a high-performing team that shows up for each other and stays focused on making a difference for patients and families. Our leadership is transparent and empowering, and our culture is built on trust, flexibility, and accountability—encouraging ownership and innovation every day.Our Science: Advancing Cancer Immunotherapies Candel is a clinical-stage biopharma company developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses. Our platforms use genetically modified adenovirus and HSV constructs. With positive Phase 3 results for our lead candidate, it’s an exciting time to join us and help bring transformative cancer treatments to patients. Learn more: www.candeltx.comPosition Summary The Associate Director, Regulatory Affairs will serve as a regulatory strategist supporting one or more development programs across the product lifecycle, from clinical development through marketing authorization and post-approval maintenance. This is a global role with primary responsibility for developing and executing regulatory strategies that enable efficient multinational clinical development and timely marketing approvals across major markets, including the US, EU, UK, Japan, and other regions. The successful candidate will bring substantial experience navigating the global regulatory landscape for biologics, with demonstrated expertise in late-stage clinical development and ex-US health authority interactions. The ideal candidate will have familiarity with oncology product development as well as the unique regulatory considerations for advanced therapy medicinal products (ATMPs).What You’ll Do Global Regulatory Strategy - Develop, communicate, and execute global regulatory strategies for assigned programs, ensuring alignment across US (FDA), EU (EMA), UK (MHRA), Japan (PMDA) and other target markets. - Lead the preparation of global regulatory submission plans, including sequencing and interdependencies across INDs/CTAs, Orphan Drug Designations, Pediatric Study Plans/PIPs, Breakthrough Therapy / PRIME / Innovation Passport designations, and marketing applications. - Provide regulatory input to clinical development plans, protocol design, and study endpoints, ensuring alignment with health authority expectations and regional requirements. - Advise on regulatory implications of evolving clinical data, including benefit-risk assessment, labeling strategy, and indication scope. - Develop and maintain regulatory risk assessments and mitigation strategies for assigned programs. Ex-US Health Authority Interactions - Develop relationships with expert regional consultants/services for advice and local legal and health authority representation - Serve as a primary Candel regulatory point of contact via regional consultants/services for health authority interactions across multiple regions, including EMA (Scientific Advice, CHMP/CAT interactions), MHRA, PMDA, and other national competent authorities. - Lead preparation of briefing documents, meeting requests, and regulatory correspondence for health authority meetings by managing activities of outside consultants/services. Regulatory Submissions & Operations - Oversee preparation and submission of CTAs across multiple countries, in conjunction with a CROs as applicable, ensuring compliance with regional requirements and timely site activations for multinational clinical trials. - Lead the preparation of ex-US marketing applications (MAAs), including coordination of Module 1 regional requirements and assist in the development of core dossier Modules 2–5. - Ensure consistency and quality of regulatory documents across submissions, maintaining a coherent global regulatory narrative. - Manage regulatory aspects of protocol amendments, safety reporting obligations, and annual reporting requirements across active INDs/CTAs globally. Cross-Functional Partnership & Regulatory Intelligence - Partner with Clinical, CMC, Quality, Research, and Commercial teams to ensure regulatory alignment across all functional deliverables. - Collaborate with CMC regulatory colleagues on integrated regulatory strategy, particularly for programs involving novel manufacturing platforms or ATMP-specific regulatory pathways. - Monitor and interpret evolving regulatory guidance, legislation, and policy across major markets, with particular attention to oncology/immuno-oncology regulatory trends, ATMP/gene therapy frameworks, and expedited development pathways. What You’ll Bring Education: - Bachelor’s degree - RAC certification is a plus Minimum Experience: - 8+ years of progressive experience within the biopharmaceutical industry, with a minimum of 5 years focused in regulatory and a substantial portion in global or international regulatory roles preferred. - Direct experience supporting multinational late-stage (Phase II/III or pivotal) clinical trials, including multi-country CTA submissions and management of region-specific regulatory requirements. - Demonstrated experience working with ex-US health authorities, including EMA (centralized procedure, Scientific Advice, CAT/CHMP interactions), MHRA, Health Canada, PMDA, TGA, or other major regulatory agencies. - Experience with biologics development, including familiarity with the regulatory framework for biological products - Experience working with CROs and regulatory consultants to manage multi-country regulatory filings and health authority interactions - Track record of authoring or leading the preparation of major regulatory submissions (INDs/CTAs, marketing applications, or significant supplements/variations). - Strong working knowledge of ICH guidelines, FDA regulations, EU regulatory framework (Regulation 536/2014, centralized/decentralized procedures), and eCTD format. Additional Preferences: - Direct experience with the preparation and submission of a Marketing Autorisation Application (MAA) through the EMA centralized procudure, including interactions with the rapporteur/co-rapporteur, responses to Day 120/180 questions, and oral explanations. - Experience with gene therapy, cell therapy, or other ATMP products, including familiarity with EMA’s CAT (Committee for Advanced Therapies) review pathway, ATMP classification, and the distinct regulatory considerations for these modalities (e.g., long-term follow-up requirements, conditional marketing authorization, hospital exemption frameworks). - Excellent written and verbal communication skills, with the ability to articulate complex scientific and regulatory concepts clearly and concisely. - Proven leadership and interpersonal skills, with the ability to influence and collaborate effectively with diverse cross-functional teams and external stakeholders. - Strategic thinker with strong problem-solving and decision-making abilities. - Ability to manage multiple projects simultaneously in a fast-paced and dynamic environment. - Proven collaboration with Clinical, Biostatistics, Regulatory, Safety, Research and CMC; consistent milestone and risk tracking with timely issue resolution. - Core working hours will be based in U.S. Eastern Time. The successful candidate must have flexibility to participate in meetings outside of core hours as needed to support collaboration with international teams across Europe and Asia. Applicants must be legally authorized to work in the United States at the time of hire and throughout employment. We are unable to provide, assume, or sponsor work visas or employment authorization for this role now or in the future.