Agenus Inc.

The Role: Agenus is searching for a collaborative, resourceful, and innovative Director, Safety Science (MD) to work in conjunction with the Safety Medical team to provide scientific/clinical expertise, strategic input, support for deliverables and activities associated with signal management activities, aggregate reports, benefit-risk evaluations for assigned products, and providing support and assistance in crafting responses to regulatory authorities as appropriate. As the Director of Drug Safety and Pharmacovigilance, you will play a key role in characterizing the safety profiles of Agenus’ compounds and mitigating and communicating their risks throughout the product lifecycle (from First-In-Human to post-marketing). This role will conduct and oversee cross-functional Signal Detection and Safety Surveillance, guiding the analysis, interpretation and presentation of safety data to stakeholders as needed. This role also contributes to the safety content of regulatory and study documents and collaborates actively with colleagues in numerous cross-functional departments. You will interact with stakeholders ranging from colleagues at Agenus to regulatory authorities. In the role you will: - Perform safety review of Adverse Event reports for Agenus products. - Perform ongoing surveillance (including signal detection/evaluation) of Agenus clinical trials and post marketing safety data - Lead active monitoring and continual assessment of safety profiles through systematic signal detection and critical review of aggregate safety data from various sources - Be the primary safety contact for other departments and ensure appropriate and timely handling of safety issues. - Provide safety review and safety science to various documents including but not limited to: Protocols, IBs, ICFs, SAPs/ TFLs, Medical Monitoring Plans, CSRs, ad-hoc safety queries, health authority questions, etc. You will also be contributing to the development of other documentation such as: Investigator’s Brochures, and Subject Informed Consent - Proactively resolve issues, propose solutions, and escalate to PSL accordingly. - Signal assessment strategy and assess potential impact to the product safety profile with recommendation for action. - Collaborate with Data Analytics, Biostats and Data Management to ensure that outputs of safety data from both safety and clinical trial databases are standardized and of high quality to meet the need for preparation of aggregate safety reports including DSUR, PBRER and other required aggregate safety analyses required by regulatory authorities. - Lead authorship of aggregate reports, exercising judgment in method selection and networking with cross-functional stakeholders to ensure high-quality and timely submissions. - Collaborate with the clinical development team to develop and implement a comprehensive safety surveillance strategy for clinical trials across different platforms. - Lead and perform in-depth evaluation of safety data from multiple sources to support product safety surveillance and signal detection activities, partner queries, and health authority requests. Support internal PV audits, regulatory inspections, updates to safety management plans, and Sponsor training materials. - Author and contribute to SOPs, WIs, and corporate policies to maintain a state of inspection readiness. - Maintain a central repository of drug safety documents, including records of signal detection and other PV activities pertinent to regulatory inspections. - Conduct signal detection, including adverse event data, literature and other sources in collaboration with PV Physician and according to Agenus Signal Management and Safety Governance process. - Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection. - Manage and prioritize safety signals, ensuring effective risk mitigation and response. - Perform data analysis to evaluate safety signals and prepare written signal analysis reports. - Collaborates with Safety Medical for signal detection activities including monthly SAE reviews, bi-annual clinical and safety reviews, and any ad hoc analysis as appropriate. - Project Management of periodic aggregate safety reports (e.g. PBRERs, DSURs), as well as reviewing the content and authoring of portions of these documents. - Evaluate and document safety assessment, and if warranted, prepare safety assessment reports and other safety documents and regulatory responses. - Prepare and present the Global Safety Team’s recommendations on safety issues to cross-functional decision-making bodies. - Collaborate with other functional areas to achieve business goals and objectives. Qualifications: About You - MD required (not PharmD) with 8+ years experience in clinical development pharmacovigilance - Safety Scientist for products in the clinical trial and post-marketing environments - Experience within the field of oncology is required - Demonstrated hands-on safety science experience in immuno-oncology (IO) programs is strongly preferred, including direct involvement in safety strategy, signal evaluation, and benefit-risk assessment. - Experience supporting early-phase (First-in-Human) programs and/or expanded access / compassionate use settings (e.g., EAP/AAC) strongly preferred - Experience authoring safety signal assessment report, DSUR, PBRER, RMP, and RSI - Skilled in signal detection process and managing safety information from clinical development and post-marketing sources. - Prior experience as a Safety Scientist and competency around safety scientist core responsibilities including: - Signal detection and signal management strategy and execution. - Aggregate safety analysis with a particular focus on early development for Phase I, Phase II/III, and filing pharmacovigilance activities. - Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management. - Documented experience from overseeing multiple trials with safety inputs at the Global level. - Ability to influence cross-functional teams and contribute to safety governance decisions at a global level - Sound strategic evaluation, analysis, and decision-making skills. - Ability to work effectively in a dynamic, complex, and fast-paced team environment. #LI-JW1

The Role: We are seeking a hands-on Pharmacovigilance Operations professional to support clinical-stage oncology programs. This role will be responsible for direct execution of PV activities, including case review, safety document authoring, and signal detection, while partnering closely with cross functional teams. In the role you will: Core PV Operations - Perform hands-on review of Individual Case Safety Reports (ICSRs), including assessment of seriousness, expectedness, and regulatory reporting requirements. - Author and contribute directly to DSURs, Investigator Brochures (IBs), and other aggregate safety reports, including safety narratives and data interpretation. - Conduct and support signal detection and safety trend analyses, including preparation of data listings and participation in safety review meetings. - Work directly in the safety database (e.g., Argus/ARISg) to review, QC, and manage safety data. Operational Execution & Quality - Support day-to-day pharmacovigilance operations, ensuring timely, accurate, and compliant safety reporting. - Partner closely with safety vendors, performing quality review of deliverables and following up on queries and timelines. - Support SAE reconciliation between clinical and safety databases. - Contribute to the development and maintenance of SOPs, Safety Management Plans (SMPs), and work instructions. Cross-Functional Collaboration - Collaborate with Medical Safety, Clinical Operations, Data Management, and Regulatory Affairs to ensure consistent and compliant safety data. - Participate in safety review committees and study team meetings as an operational PV representative. - Support inspection readiness activities, including documentation preparation and response support. Qualifications: About you - 4–8 years of direct pharmacovigilance or drug safety experience, with a strong emphasis on hands-on execution. - Demonstrated experience with: - ICSR review and processing - DSUR and IB safety section writing - Signal detection or safety data trending - Working knowledge of GCP, GVP, and ICH guidelines. - Experience using global safety databases (Argus, ARISg, or similar). - Ability to work independently in a lean, fast-moving biotech environment. - Oncology or immuno-oncology experience. - Prior experience supporting clinical-stage programs. - Experience contributing to audits or inspections. #LI-JW1

The Role: The Regional Medical Leader (RML) is a senior field-based scientific ambassador for Agenus, operating at the intersection of medical strategy, scientific engagement, and regional leadership. This hybrid Medical Advisor–MSL role requires strong scientific credibility, strategic clarity, and the ability to influence clinical practice within Oncology, Immuno-Oncology and GI malignancies, including MSS-CRC. The RML represents Agenus’ scientific vision in the field, builds trust with leading clinicians, and helps shape how innovation is understood and adopted across the region. In the role you will: - The RML develops and executes the regional medical plan, providing a refined understanding of clinical dynamics, referral pathways, and emerging needs. He or she engages KOLs through impactful scientific dialogue, contributes to clinical research activities, and ensures that field insights inform national decision-making. - This role strengthens Agenus’ scientific credibility by bringing medical clarity, engaging experts with depth and authenticity, and supporting evidence‑generation initiatives that align with the company’s oncology strategy. Scientific Engagement: - The RML demonstrates strong command of immunology, biomarkers, tumor biology, and the evolving GI/IO landscape. This expertise enables high‑level scientific discussions and positions the RML as a trusted counterpart for clinicians. The role blends scientific rigor with strategic listening, ensuring meaningful and influential exchanges. Strategic Insights& Cross-Functional Collaboration - By analyzing medical trends, competitive changes, and clinical behavior, the RML provides insight that supports strategic planning and launch excellence. Collaboration with Market Access, HEOR, Regulatory and Commercial (in a strictly non‑promotional context) ensures scientific alignment across the organization. Operational Excellence - The role requires autonomy, organizational discipline, and respect for medical governance. The RML manages regional responsibilities with maturity, clarity, and a strong ethical mindset. Qualifications: About you - The ideal candidate is an MD, PharmD or PhD with solid experience in oncology and Medical Affairs, able to interact credibly with national experts. He or she brings analytical depth, scientific presence, and the ability to translate complexity into clear medical value. The Agenus environment suits individuals who are agile, rigorous and motivated by scientific impact. - Candidates must be based in France and able to travel regularly across the assigned region to engage oncology investigators and treatment centers. #LI-JW1