Associate Director, Pharmacovigilance Scientist

🔥 6 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $184k - $200k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Candel Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1999

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Candel Therapeutics is a clinical-stage biotechnology company developing off-the-shelf engineered viral immunotherapies for solid tumors. The company advances two genetically modified viral platforms: aglatimagene besadenovec (CAN-2409), an intratumoral adenoviral gene therapy encoding HSV-thymidine kinase used with oral prodrugs to induce immunogenic cell death and CD8+ T cell–mediated anti-tumor immunity; and linoserpaturev (CAN-3110), a replication-competent, Nestin-promoter–controlled oncolytic HSV designed for tumor-specific killing (notably high-grade glioma). Candel reports Phase 3 data for aglatimagene in prostate cancer with strong pathological response rates and has received FDA Fast Track and RMAT designations; it positions itself as an immuno-oncology company focused on improving outcomes and preserving quality of life.

📋 Description

• Support ongoing safety evaluation and pharmacovigilance activities for all Candel products across clinical development and applicable post-marketing readiness • Perform sponsor review and approval of serious adverse event and other individual case safety reports in Argus • Assess case completeness, medical consistency, query adequacy, coding accuracy, narrative quality, causality, expectedness, reportability, and required follow-up • Author and contribute to safety topic reviews, signal evaluations, aggregate safety analyses, benefit-risk assessments, and safety summaries • Support internal governance, regulatory submissions, Investigator Brochure updates, DSURs, clinical study reports, and other clinical or regulatory documents • Support implementation and continuous improvement of Candel’s signal management process and platform • Review clinical trial, safety database, clinical database, literature, nonclinical, and other relevant safety data to identify emerging concerns and changes in known risks • Partner with Clinical Development and study teams on protocols, amendments, safety monitoring plans, adverse event reporting sections, and other safety documents • Contribute to SAE reconciliation, safety data review meetings, Safety Management Team or Safety Governance Team activities, Data Monitoring Committee support, and cross-functional patient-safety discussions • Support Reference Safety Information, expectedness criteria, adverse event terms of special interest, product risk language, and other safety content • Collaborate with pharmacovigilance vendors and CROs on case processing, query resolution, safety database documentation, safety management plans, and delegated activity oversight • Provide pharmacovigilance input to regulatory responses, health authority questions, inspection readiness, SOPs, work instructions, vendor oversight plans, training materials, and process improvement initiatives • Maintain current knowledge of global pharmacovigilance regulations, ICH guidance, FDA requirements, EU GVP expectations, oncology safety considerations, MedDRA terminology, and evolving clinical safety surveillance practices • Report to the Senior Director, Pharmacovigilance and Safety

🎯 Requirements

• Advanced degree in a health sciences or life sciences discipline preferred, such as PharmD, MSN/NP, MPH, or related field • Bachelor’s degree in nursing, pharmacy, biological sciences, public health, or a related discipline may be considered with significant relevant pharmacovigilance, clinical safety, or drug development experience • Typically 8 or more years of relevant experience in pharmacovigilance, clinical safety, drug safety science, clinical development, or a related function within biotechnology, pharmaceutical, or CRO settings • Oncology and/or gene-mediated therapy experience preferred • Strong working knowledge of global pharmacovigilance requirements and guidance, including ICH GCP, ICH E2 guidance, FDA IND safety reporting requirements, EU clinical trial safety reporting expectations, and Good Pharmacovigilance Practice principles • Hands-on experience with safety databases, preferably Argus, including review of individual case safety reports, case narratives, medical coding, queries, workflow routing, and sponsor approval activities • Ability to review complex clinical and safety data, synthesize medical and scientific evidence, and prepare clear, balanced, well-supported written safety assessments • Experience contributing to safety sections of clinical protocols, Investigator Brochures, DSURs, clinical study reports, safety monitoring plans, signal assessments, regulatory responses, and related clinical or regulatory documents • Knowledge of signal detection and signal management practices, including aggregate review, case series evaluation, literature assessment, documentation of rationale, escalation of emerging safety issues, and governance support • Excellent written and verbal communication skills • Strong organizational skills and attention to detail, with the ability to manage multiple priorities, timelines, vendors, and deliverables in a small-company environment • Collaborative, proactive, and accountable working style, with the ability to operate independently while maintaining close alignment with internal stakeholders and external partners • Must be authorized to work in the US and not require sponsorship

🏖️ Benefits

• Supportive, mission-driven environment • Diversity, collaboration, and bold thinking culture • Transparent and empowering leadership • Flexibility and accountability • Ownership and innovation opportunities • Remote or hybrid work arrangement

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