Position Type: Full time
Location: CARMEL, IN, US

Position Summary:

The Director of Toxicology works in a Team environment (toxicology, pharmacology, medical, regulatory, CMC) to design, interpret and report nonclinical in-vitro and in-vivo toxicology and pharmacology studies for MBX Biosciences discovery and development programs. This will include exploratory studies, and GLP studies to support regulatory filings. In addition, the Director will liaise with discovery and development colleagues to develop overall toxicology and safety pharmacology strategies.  She/He will regularly interface with internal and external colleagues to provide timely and accurate dissemination of relevant safety data. The Director will also work collaboratively with executive management to develop key program strategies which will strengthen the MBX capabilities focused on early and late clinical drug development activities for small and large molecules.  The Director will work with external partners such as CROs to conduct the necessary studies to support drug development, and to monitor study progress.

The Director, Toxicology will report to the Vice President, Pharmacology and Toxicology.

Key Responsibilities:

• Lead preclinical toxicology programs for small and large molecules in discovery and development stages
• Formulate preclinical toxicology strategies to then allow seamless integration into workflow to advance programs
• Interface with internal stakeholders in discovery and development
• Interface with regulatory agencies
• Lead the optimization of toxicology programs by identifying, developing, and implementing screening strategies for target validation
• Guide investigative efforts to define mechanism of toxicity
• Work with Medical to develop nonclinical strategies, 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 input on strategic and tactical direction for multiple project teams as they advance molecules from target discovery through lead optimization to clinical development. Prepare or review study reports for regulatory submission on development candidates. Write toxicology and pharmacology sections of regulatory documents, including but not limited to the IND, IB and BLA
• Contributes to new project ideas and in vivo proof-of-concept studies to enable the initiation of new peptide projects

Qualifications/Requirements/Personal Competencies:

• PhD in Toxicology, Pharmacology, or related sciences, with minimum six (6) years of professional experience in drug discovery and development
• Diplomate American Board of Toxicology (DABT)
• Excellent communication and interpersonal skills, with the ability to effectively:
  • influence opinion and actions
  • communicate strategies, plans, results, and analysis
• A mix of experience across pharmaceutical companies and toxicology CROs would be desirable
• 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 preparation of INDs, BLAs, NDAs
• Record of publications and presentations at National Meetings
• Direct leadership experience
• Experience and success in designing non-GLP and GLP safety studies
• Strong interpersonal skills and ability to represent Nonclinical Development in cross functional teams
• 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 both a team contributor and team leader, taking ownership of multiple projects

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