Principal Scientist, Toxicology

Categories: Toxicology
Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and robust pipeline across preclinical and clinical development. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Come join our team as we transform the lives of others.
Position Summary:
The Principal Scientist, Toxicology will have overall responsibility for leading discovery safety screening efforts and overall safety pharmacology strategies to enable data-driven safety decisions regarding the advancement of novel molecules proposed for use in therapeutic development programs. The individual will be responsible for establishing toxicology and non-clinical safety workflows (e.g., in vitro, ex vivo, and/or in vivo) to identify hazards across multiple target organs.
This role will be considered a subject matter expert (SME) in safety pharmacology, with experience in screening cascades used to rank order drug candidates, will be skilled at designing experiments to understand the translation of data across research formats, and will ensure study documentation and reporting that adheres to departmental policies and regulatory expectations. Other duties include collaborating extensively with colleagues within the Toxicology department and will also be responsible for establishing and maintaining strong relationships with other functional line stakeholders (Chemistry, Biology, PK/PD and Clinical Pharmacology) to achieve program and corporate goals.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
  • Design and interpret fit for purpose safety pharmacology packages and guide projects with tangible, quantitative risk assessments that underpin science-driven decisions.
  • Identifying off-target risks of concern, interpreting undesirable off target pharmacological interactions and translating in vitro activity at specific targets to pre-clinical and clinical adverse events to contextualize the potential safety related risks
  • Provide expert input into the design, conduct and interpretation of non-clinical Safety Pharmacology studies, ensuring the delivery of high-quality documentation to enable clinical studies and marketing authorization of our medicines. 
  • Collaborate with functional line stakeholders within/external to the Toxicology team to design in vitro, ex vivo, and in vivo experiments to understand the translation of safety data across research formats.
  • Author non-clinical safety pharmacology sections of regulatory submission documents and engage with regulatory authorities to secure approval of IMPD/IND and MAA/NDA submissions.
  • Ensure study documentation and reporting that adheres to departmental policies and regulatory expectations
  • Provide strategic advice to program teams and senior management including evaluation of conclusions and potential impact of toxicology results on program and clinical/regulatory strategy
  • Proactively plan discovery toxicology strategies that can be used to support clinical development and marketing of drug candidates
  • Drive the identification, evaluation, selection and management Toxicology and Safety Pharmacology CROs, act as technical expert and ensure CROs have sufficient capabilities, resources to executes against contractual obligations
  • Evaluate and implement protocol preparation for assigned Toxicology and Safety Pharmacology studies.
  • Manage the conduct and reporting of individual studies, including study placement, contract development/budgeting, coordination of pre-study activities, and approving study protocols and reports
  • Continuously perform extensive analyses/interpretations of Toxicology/Safety Pharmacology data and serves as a key opinion leader(s) making a go/no-go decision. 
Education and Experience: 
  • PhD with 12 years of safety Pharmacology experience in drug discovery and development, with exposure to non-clinical safety assessment in a project setting.
  • Experience in discovery safety screening efforts and early toxicology strategies that influence the development of programs across multiple therapeutic modalities
  • Experience in the report generation of early discovery safety data used in health authority dossiers
  • Familiarity with GLP regulations and ICH/FDA guidelines for the conduct of toxicology studies to support regulatory filings
  • Experience working with Contract Research Organizations
  • Ability to develop and deliver clear and concise presentations for both internal and external meetings
  • Outstanding written and verbal communication skills Ability to multi-task and quickly change priorities Excellent written, communication and interpersonal skills and proven success working in a multi-functional team-based environment
  • Must be able to thrive in a dynamic, small, growth company environment.
  • Exercises judgment within generally defined practices and policies
  • Effective presentation skills to key stakeholders and key decision makers
  • Ability to work collaboratively across the organization to achieve corporate objectives is essential
  • Excellent team management skills, ability to lead, train and mentor team members at all levels
  • Ability to set and follow through goals with a sense of urgency while keeping broader strategic objectives in focus
  • A hands-on approach to performing duties with a strong self-directed work ethic and attention to detail
  • Collaborative attitude and ability to motivate and influence others without relying on position or power
  • Strong organizational and time management skills in order to balance working on multiple projects in parallel
  • Must understand and respect company core values and possess the highest integrity 
Physical Demands and Work Environment:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting, up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
You may be required to travel for up to 20% of your time. 
The Anticipated Base Salary Range: $175,000-$214,388
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process. 
Equal Opportunity Employer: 
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws 
Vaccination requirement: 
Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.