Responsibilities include the following. Other duties may be assigned.
- Lead scientific, technical, and business-related risk assessments to assist in CRO selection and evaluations, including leading and managing the Request for Proposal process
- Perform CRO on-site assessments of CROs for pharmacokinetics, toxicology, safety pharmacology, and developmental and reproductive toxicity studies
- Design, supervise, analyze, interpret, and report in vivo non-GLP and GLP studies conducted at CROs including PK, toxicology and safety pharmacology studies in collaboration with study monitors and other scientists. Ensure appropriate quality of documentation and record keeping are compatible with global regulatory submission requirements.
- Work collaboratively with CROs and internally across-disciplines to coordinate study timelines and deliverables
- Accountable for critical documents including study protocols, reports, nonclinical sections of regulatory documents. May contribute to manuscripts and regulatory submissions.
- Candidate should have strong critical thinking and research skills and a desire to conduct early development /mechanistic studies as well as GLP-compliant IND enabling toxicity studies.
- Develop and maintain cross-departmental collaborations and shared work practices across functional groups and participate in project teams.
- Contribute to departmental processes such as SOPs and templates.
- Ph.D. in Pharmacokinetics/Pharmacology/ Toxicology/ Biological Sciences or related discipline with 2+ years of biotech, pharmaceutical industry or CRO experience; MS +5 years experience or BS with +8 years experience.
- Demonstrated comprehensive knowledge of designing, conducting and interpreting nonclinical PK, PD and toxicology studies.
- Strong knowledge of nonclinical drug development, FDA and ICH guidances, and GLP regulations.
- Direct experience working on multidisciplinary drug development project teams and comprehensive knowledge of drug development strategy.
- Outstanding organization and planning skills, and the ability to multi-task and understand project team deliverables.
- Proficient at critically reading and applying relevant scientific literature.
- Excellent analytical and soft skills to interact effectively and harmoniously with vendors and stakeholders.
- Proven ability to thrive in a collaborative team environment: strong oral and written communication skills, and a helpful team spirit.
- Demonstrates a sense of urgency, proactive and creative thinking, and productivity in a fast-paced, innovative and team-oriented environment.
- Travel required up to 30% per year to monitor outsourced studies (domestic and international.)