Toxicologist

Position Summary:

The Toxicologist works in a team environment (toxicology, pharmacology, medical/clinical, regulatory, CMC) in Biotech drug discovery and development. The position includes study design and implementation, development of relationships with Toxicology CROs and University Discovery Pharmacology activities, data reduction, data interpretation, and data presentations. This will include exploratory studies, and GLP studies to support regulatory filings. In addition, the Toxicologist will liaise with discovery and development colleagues and participate in development of the overall toxicology and pharmacology strategies. She/He will regularly interface with internal and external colleagues to provide timely and accurate dissemination of relevant safety data. The Toxicologist will 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.
• 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.
• Monitor toxicology, TK, and pharmacology studies at CROs and Universities (GLP and nonGLP).
• Work with Medical/Clinical 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.

Qualifications/Requirements/Personal Competencies:

• M.S. or PhD in Toxicology, Pharmacology, or related sciences.
• Diplomate American Board of Toxicology (DABT) eligibility is required.
• Excellent communication and interpersonal skills, with the ability to effectively:
• Ability to influence opinion and actions
• Ability to communicate strategies, plans, results, and analysis.
• Drug development experience in the CRO environment is preferred
• 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
• Experience in study monitoring
• 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.

Company Overview:

MBX Biosciences is a clinical-stage biopharmaceutical company pioneering Precision Endocrine Peptide (PEP) therapeutic candidates to help people with endocrine disorders live fuller and healthier lives.

A distinguishing strength of MBX is world-class proprietary peptide drug discovery. Our team is driven to transform the current treatment landscape with highly efficacious, safe, and convenient medicines that are designed to address unmet needs in both rare and prevalent endocrine diseases. We are combining our deep expertise in peptide discovery and development with our novel, proprietary platform technology to advance our pipeline.

Our lead programs have clinically validated targets and attractive endocrine disease market opportunities. MBX 2109 is an investigational long-acting parathyroid hormone peptide prodrug in development as a PTH replacement therapy for the treatment of hypoparathyroidism. The company is building a pipeline of additional product candidates to treat endocrine disorders that will enter Phase 1 development in 2023.

MBX is supported by leading life science investors including Frazier Life Sciences, New Enterprise Associates, OrbiMed, Wellington Management, RA Capital and Norwest Venture Partners. We are based in the Indianapolis area and growing rapidly in a hybrid workplace environment. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, passionate about their work, and able to work in a dynamic environment.

EEO Statement:

MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.