Associate Study Director Req# 2116
Encoded Therapeutics, United States
Job Description
Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.
Encoded is looking for an experienced and highly motivated Study manager, who will be responsible for outsourced Good Laboratory Practices (GLP) and non-GLP primate studies to assess safety and vector biodistribution for CNS indications. The successful candidate will be responsible for study management including CRO site selection, protocol development, study coordination and monitoring, study execution, data collection and all reporting activities. Additionally, the position will be responsible for GLP audits and manage subcontracts and contracts for these studies.
Responsibilities
- Responsible for CRO site selection, scheduling, monitoring and executing of primate studies.
- Lead protocol development efforts working cross functionally with internal and external teams involved in the pathology, bioanalytical and toxicology related assessments.
- Serve as sponsor representative to conduct on-site study monitoring for surgery and specimen collection.
- Lead efforts to coordinate with Encoded Supply Chain and Biorepository teams to ensure sample shipment from the CRO sites for analysis.
- Effectively use program management skills to track study timelines and confirm all study related deliverables are met.
- Maintain and organize data files and reports across outsourced studies.
- Review study reports generated by CRO to maintain quality of the studies and reports.
- Contribute to study results for US and Ex-US regulatory submissions.
Requirements
- PhD in biological science with 6 or more years of pharmaceutical/biotechnology experience in the area of preclinical toxicology in large animal models and testing performed under Good Laboratory Practices (GLP, 21CFR, Part 58) OR
- Master’s in in biological science with 10 or more years of pharmaceutical/biotechnology experience in the area of preclinical toxicology in large animal models and testing performed under Good Laboratory Practices (GLP, 21CFR, Part 58)
- Demonstrated history of working in teams supporting safety assessments for biologics in primates, familiarity with multiple routes, including surgical methods, of drug administration
- Proven ability to work with high level of integrity, accuracy and attention to details; supported by excellent time management and organizational skills
- Strong communication and interpersonal skills; presentation to internal teams on study updates; external meetings with CRO to track deliverables
- Problem solving and critical thinking skills
- Proficiency with Microsoft Office (Excel, PowerPoint, Word, Teams), Graphpad prism, SAS JMP
Preferred Qualifications
- Experience with toxicology teams in conducting primate safety assessments for CNS indications, including investigating mechanisms of toxicity in large animal models
- Previous genetic therapy experience (e.g. Anti Sense Oligonucleotides, Cell or Gene Therapy)
Benefits
- Comprehensive benefits package, including competitive employer premium contributions
- Meaningful stock option grants
- PTO, sick time and holiday pay
- Generous Parental Leave program
- Pre-tax medical and dependent care programs
- LTD, Life, and ADamp;D
- Professional development opportunities
- Team-building events
- Fully stocked kitchen
- Purple Tie dry cleaning service
- Fitness center
Encoded Therapeutics, Inc. is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.
If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272.