Position SummaryThe Scientist, Pharmacology and Toxicology, reporting to the Sr. Director of Pharmacology & Toxicology is an individual contributor who works in a team environment (toxicology, pharmacology, medical/clinical, regulatory, CMC) in biotech drug discovery and development. The position includes study design and monitoring, development of relationships with toxicology CROs and university discovery pharmacology activities, data review, data interpretation, and data presentations. This includes exploratory studies and GLP studies to support regulatory filings. In addition, the role will liaise with discovery and development colleagues and participate in development of the overall toxicology and pharmacology strategies. The role will contribute strategically to the development of assets including presenting these strategies to the asset development team as needed to ensure alignment. This role will also work with external partners such as CROs to conduct the necessary studies to support drug development and to monitor study progress.
Key Responsibilities- Support the conduct of preclinical toxicology programs for small and large molecules in discovery and development stages.
- Propose and support the development of preclinical toxicology strategies to advance programs.
- Interface with internal stakeholders in discovery and development.
- Interface with MBX regulatory affairs on documents for FDA and other regulatory bodies.
- Work with the clinical group to develop nonclinical timelines, and risk-benefit approaches for molecules selected to move forward to FIH trials.
- Establish collaborations with CROs and/or academic institutions supporting MBX drug development programs.
- Provide tactical support for multiple project teams as they advance molecules from target discovery through lead optimization to clinical development.
- Support writing of toxicology and pharmacology sections of regulatory documents, including but not limited to the IND, IB and BLA.
- Other duties as assigned.
Education& Qualifications- B.S., M.S., or PhD in Toxicology, Pharmacology, or related sciences.
- Minimum of 5 years of related experience in biopharma or a CRO.
- Excellent communication and interpersonal skills, with the ability to effectively influence opinion and actions.
- Communicate strategies, plans, results, and analyses.
- Study directing or monitoring experience in the CRO environment.
- Demonstrated scientific excellence in the application of toxicology and pharmacology principles across pharmaceutical research and development.
- Knowledge of U.S. and International safety guidelines and requirements for pharmaceutical development.
- Ability to think strategically and to provide clear direction and expectations to other team members in a highly dynamic environment.
- Strong ability to prioritize daily work based on changing business requirements.
- Self-motivated, independent, and results oriented.
- Ability to work productively in a matrix environment, as a team contributor supporting multiple projects.
TravelThis role is expected to be on site 3 days per week. You will be expected to travel periodically based on the needs of the business to the extent requested by the Company, including attendance at Together Weeks, Together Days, and functional meetings as requested by the Company.
