Job Description

Job Title: Associate Director/Director Non-Clinical Safety (Toxicology)

Job Location: United States

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: Director

Mural Oncology is a clinical-stage oncology business focused on discovering and developing immunotherapies that may meaningfully improve the lives of patients with cancer. By leveraging its core competencies in immune cell modulation and protein engineering, Mural Oncology has developed a portfolio of novel, investigational cytokine therapies designed to address areas of unmet need for patients with a variety of cancers. The Company's lead product candidate, nemvaleukin alfa, is an investigational, engineered interleukin-2 (IL-2) cytokine designed to capture and expand the therapeutic benefits of high-dose recombinant human IL-2, while mitigating its hallmark toxicities.

Serving as the function head, this role will lead the Non-Clinical safety strategy and execution for programs from discovery through late stage. This role will also oversee aspects of investigative toxicology, strategic review and interpretation of all non-GLP and GLP toxicology studies, collaborate with team members, project teams, and external partners to ensure alignment and drive excellence in nonclinical safety practices.

Essential Areas Of Responsibility

• Serve as the primary non-clinical safety lead and will be responsible for designing, implementing and analyzing project-specific nonclinical toxicology studies (non-GLP and GLP), and ensure execution of toxicology studies to support company timelines and goals for both new and existing oncology agents.
• Develop and implement Non-Clinical safety strategy. Oversee the selection and management of consultants and CROs. Manage nonclinical safety studies conducted by CROs with efficient governance by reporting progress to stakeholders, interpreting the data, reviewing draft study reports, completing contract and budgetary milestones and study close-out, and aligning nonclinical safety evaluations with drug development efforts and priorities.
• Prepare all Non-Clinical safety-relevant documents to support regulatory filings including initial INDs, IND annual updates, IBs, DSURs.
• Initial BLAs/review queries, as well as briefing books for US FDA, EMA, and other international regulatory meetings and filings.
• Respond with scientifically robust rationale to questions from US FDA, EMA, and other health authorities in support of development programs
• Collaborate with CMC, Program & Portfolio Management, Clinical, and Regulatory Affairs to develop program-specific strategies for appropriate data generation in support of development candidate nomination, IND filing, and clinical development of biologics.
• Provide leadership and management support that can build and inspire our team and drive collaboration and innovation
• Represent Non-Clinical Safety at cross-functional project and safety teams as well as leadership teams/reviews

Minimum Education & Experience Requirements

• PhD and/or DVM in Toxicology or related health discipline with 10+ years of toxicology experience in the pharmaceutical and/or biotechnology industry.
• Current knowledge of FDA regulatory guidance related to nonclinical safety.
• Experience with direct interaction with the FDA.
• Experience in submission of IND, NDA/BLA and other regulatory documents is required.
• Scientific and financial oversite of CROs
• Ability to oversee contractors in addition to being an individual contributor.
• Scientific writing and presentation skills are essential; peer reviewed publications in a relevant field are valued.
• Understanding of, and compliance with, regulatory, protocol, standard operating procedures, and Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) as appropriate.
• Excellent interpersonal, leadership, communication and time-management skills are essential; demonstrated direct management of internal and external personnel (outsourced projects) is required.

Mural Oncology is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Mural Oncology also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Mural Oncology is an E-Verify employer.

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