Director of Preclinical Safety
We are seeking an accomplished Director of Preclinical Safety with leadership experience in developing preclinical safety strategies and conducting GLP and IND-enabling studies, as well as overseeing and guiding the preclinical safety assessment of multiple drug candidates in parallel. The ideal candidate has extensive experience designing, monitoring, and interpreting toxicology and safety pharmacology studies, providing regulatory support and leadership, and mentoring junior scientists to advance our overall drug development strategy.
Marrow Therapeutics is a dynamic biopharmaceutical company with a mission to harness the power of precisely targeted, best in class genetic medicines to become the global leader for the treatment of hematological diseases. Leveraging our proprietary delivery platform, we achieve precise delivery of our novel therapeutics to specific cell types that are the root cause of the diseases we seek to correct.
Key responsibilities
Develop and implement preclinical safety strategies that align with the company’s overall drug development plans including building tox and safety plans for multiple indications/assets in parallel
Design and manage toxicology and safety pharmacology studies, both in-house and at external CROs, ensuring data quality and regulatory compliance
Identify and qualify vendors and monitor all preclinical safety studies
Provide toxicology support for regulatory submissions, including authoring nonclinical safety sections of regulatory documents like INDs and NDAs
Identify potential safety risks and work closely with various teams to integrate safety data and risk assessments to mitigate those risks
Communicate scientific findings and safety assessments to various stakeholders, including senior management, project teams, and regulatory agencies
Foster professional development and ensure scientific rigor by acting as a mentor and guiding junior scientists
Qualifications
DVM, Ph.D. or equivalent with board certification in a relevant field like veterinary pathology (ACVP)
10-15+ years of experience in preclinical safety, including experience in both GLP and non-GLP studies
Strong understanding of regulatory requirements for biologics and nucleic acid drug development including interactions with US and global regulatory agencies (e.g. CDER, CBER, EMA)
Deep knowledge of toxicology, safety pharmacology, pharmacokinetics and drug development process
Skills
Experience in authoring and submitting regulatory documents (INDs, NDAs, etc.)
Proven ability to work effectively in a cross-functional team environment and support developmental growth through mentoring and guiding junior colleagues
Develop and oversee PK and/or PD assays in collaboration with broader team internally/externally
Excellent leadership, communication, and interpersonal skills
Please apply through the open roles on our LinkedIn or send your resume and cover letter to careers@marrowtx.com.
This company is an Equal Opportunity Employer and does not discriminate based on race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran, disability status or any other characteristic protected by applicable law.