Senior/Executive Director, Toxicology
Senior/Executive Director, Toxicology
Reference Code – 559
Position description and scope:
An experienced toxicologist is sought to lead efforts in preclinical safety in support of the preclinical and clinical stage programs in the Regulus Portfolio. This scientist will be responsible for designing and overseeing the execution of the non-GLP and GLP safety studies for all programs. The incumbent will participate as a member of the Regulus Project Teams across all stages of research and development. The scientist will work closely with external consultants and contract organizations to support the toxicology needs of Regulus including review of safety data, regulatory document preparation, and Health Authority meetings.
- Lead all toxicology efforts to support the Regulus program portfolio including coordination of toxicology activities for all IND-enabling and early clinical studies
- Generate stage-specific and comprehensive preclinical profiling plans for the Regulus programs leveraging external CROs, consultants, and other contract organizations to support the advancement of all programs
- Design protocols for internal and external toxicology support of programs and serve as the Regulus toxicology reviewer of all studies
- Provide key input for the candidate selection criteria with input from management, project team members, and external experts
- Lead investigative toxicology efforts to understand class-related and compound-specific toxicities
- Establish the timelines for toxicology activities and oversee CRO delivery to those timelines to support program development
- Build a network of supporting CROs capable of delivering timely, high quality, and cost-effective toxicology data for research and clinical programs
- Serve as the toxicology interface with external organizations and experts including Health Authorities for Regulus programs
- Provide advice and insights regarding a range of drug development issues and scientific knowledge to fellow scientists and senior management
- Prepare appropriate overview documents for IND submissions, Investigator Brochures, and other regulatory documents
- Provide input on the strategy and research of the Regulus Portfolio via participation on the R&D Lead Team
- DVM (Pathology specialty preferred) or PhD in Toxicology (or relevant field) with 10+ years of biotechnology or pharmaceutical drug discovery/development experience
- Familiarity with pharmacokinetic and ADME principles
- Prior formal experience and line function leadership (toxicology/preclinical safety) of preclinical and clinical stage drug development teams
- Capable of working independently within a highly matrixed environment and provide cross-functional support for teams
- Demonstrated success managing interactions with external CROs, consultants, and other contract organizations
- Highly effective in team settings- willingness to openly share ideas and expertise
- Ability to thrive in a fast-paced and dynamic environment with frequent course corrections
- Excellent interpersonal and verbal/written communication skills
- High level of self-motivation, detail oriented, and ability to lead and drive problem solving with an entrepreneurial spirit
Regulus Therapeutics Inc. (Nasdaq: RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a well-balanced microRNA therapeutics pipeline complemented by a rich intellectual property estate to retain its leadership in the microRNA field. Regulus is advancing several programs in renal, hepatic and central nervous systems diseases.
Regulus is located in La Jolla, California and is led by a seasoned executive team experienced in corporate management, business, science, drug discovery and development. Regulus' scientific advisory board consists of world-class scientists and some of the foremost authorities in the field of microRNA research.
Excellent salary and benefits package offered.
For immediate consideration, please apply to email@example.com
You can visit our website to find out more about our company and culture: www.RegulusRx.com.
Reference job code: 559
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Regulus Therapeutics, Inc, is proud to be an EEO Employer.