Director, Preclinical Research & Development
The Director, Preclinical Research & Development (R&D) is a critical role within Xeris product development. The role encompasses the inception and development of new product concepts and is responsible for evaluating project rationale, objectives, and the execution of the overall preclinical strategy required for candidate validation prior to initiating clinical development activities. The Director contributes scientific expertise into the design, implementation, and validation of various in vitro/in vivo pharmacology and GLP toxicology nonclinical studies to support drug development programs and progression of Xeris development candidates. Works closely with peers in Product Development, Clinical Development, Quality and Regulatory to develop programs to progress product candidates from inception through Regulatory submissions and approval.
- Establish and manage interactions with CROs and other external partners to generate high quality data adhering to GLP standards to conduct and evaluate Xeris drug candidates in non-human pharmacology and toxicology studies.
- Identify existing animal models and oversee study designs and data generation that can be utilized for testing of candidate drugs.
- Lead the selection and qualification of laboratory facilities for conduct of studies including bioanalytical and sample analyses.
- Contribute to drug candidate selection and portfolio prioritization to recommend the best course of preclinical development in coordination with other Xeris R&D functional disciplines.
- Lead design of preclinical protocols, data interpretation including assessment of the relevance of any toxicological findings to support assessment for human safety and efficacy investigations.
- Review, analyze and provide interpretation of nonclinical Pharmacokinetic (PK), Toxicokinetic (TK) and Pharmacodynamic (PD) data for nonclinical studies and oversee report generation and approval.
- Utilize PK analysis techniques including use of WinNonlin software to conduct analyses supporting prediction of exposure and therapeutic window, interspecies allometric scaling, human equivalent dose (HED) scaling/modeling.
- Incorporate use of appropriate drug models to describe the relationship between exposure (or PK), response (or PD) for both desired and undesired effects.
- Direct the assembly of integrated PK summary documents intended for regulatory submissions, as appropriate.
- Develop project timelines and budgets in support of business needs and projections.
- Routinely report progress in a timely and concise manner to teams and Senior Management.
- Anticipate, identify, and work collaboratively to resolve issues affecting progression of studies.
- Prepare project timelines and monitor outsourced studies, critically review study results and report and approve study reports prior to finalization by the test facility.
- Interact with Regulatory personnel to author relevant sections of regulatory submission documents including INDs, NDA/BLA, MAAs as well as preclinical sections of Investigators Brochures, CTA applications, IMPDs, etc.
- Maintain up to date knowledge of regulatory agency nonclinical/clinical pharmacology and toxicology regulations/guidelines.
- Participate in cross-functional development-team activities.
- Other responsibilities and duties as required.
- A PhD in Pharmacology, Toxicology, or related area is required with at least 10 years of experience in design, planning, conduct, monitoring and reporting of pharmacology disease models, pharmacokinetics, toxicology, drug metabolism and/or clinical pharmacology.
- DABT preferred.
- In depth knowledge of animal models of drug pharmacokinetics and safety, including in a GLP environment.
- A solid understanding of statistical methods for evaluating in vitro and in vivo preclinical studies.
- Excellent communication skills, including the ability to speak, write and understand English to comply with written procedures, instructions, SOPs and other documents, as appropriate.
- Demonstrated problem-solving and organizational skills.
- A successful track record of leadership, project management, and cross functional teamwork
- Must be detail-oriented, innovative, and able to work in a hands-on manner within the team.
- A passion for working in a small, entrepreneurial, and collaborative environment.
- Excellent time and fiscal management skills.
- Brings a wealth of experience in design and execution of animal studies and assessment of therapeutic candidates in these models.
- Has a deep understanding of nonclinical drug safety and associated regulations.
- Anticipates and solves technical problems.
- Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.