Scientific Study Manager
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 Scientific Study Manager who will be responsible for centrally managing activities required for the effective design, execution, and completion of outsourced Good Laboratory Practices (GLP) and non-GLP primate studies to assess safety and vector biodistribution for CNS indications. The successful candidate will be an engaged member of the Translational team that will proactively manage multiple aspects of external studies, including, but not limited to, study planning and design, protocol development, study coordination and monitoring, study execution, data collection, and reporting activities. For Good Laboratory Practice (GLP)-regulated studies, the position will be responsible for GLP audits and ensuring compliance with appropriate GLP regulations.
- Effectively manage all aspects of outsourced GLP and non-GLP primate studies with minimal supervision, high accuracy, and scientific integrity.
- Manage progress of studies to ensure adherence to the protocol, objectives, and overall strategy.
- Anticipate and efficiently resolve/troubleshoot protocol or study-related issues or discrepancies.
- Monitor the execution of primate studies via on-site visits and frequent interactions via email/video conferencing.
- Lead efforts to coordinate with Encoded Supply Chain and Biorepository teams to ensure timely and accurate sample shipments between internal and external collaborators.
- Maintain and organize data files and reports across outsourced studies.
- Utilize program management skills to develop, track, and ensure study related deliverables are achieved according to scheduled timelines.
- Travel: Up to 10% domestic travel required to conduct on-site study monitoring as the designated sponsor representative.
- PhD in biology, neuroscience, or related sub-discipline with 6 or more years of pharmaceutical/biotechnology experience in large animal model preclinical toxicology and GLP-testing (21CFR, Part 58) OR
- Master’s in biology, neuroscience, or related sub-discipline with 10 or more years of pharmaceutical/biotechnology experience in large animal model preclinical toxicology and GLP-testing (21CFR, Part 58)
- Proven ability to work with a high level of integrity and accuracy, supported by excellent time management and organizational skills.
- Strong communication and interpersonal skills (oral and written) that enable the individual to interact proactively with CROs, facilitate external meetings, and provide frequent study updates to internal teams.
- Demonstrated history of working in cross-functional teams supporting safety assessments for biologics in primates.
- Familiarity with multiple routes of drug administration, including brain surgical methods.
- Problem solving skills, critical thinking skills, and attention to scientific detail.
- Proficiency with Microsoft Office (Excel, PowerPoint, Word), GraphPad Prism, SAS JMP
- Experience with toxicology teams in conducting primate safety assessments for Neuroscience/ CNS indications, including investigating mechanisms of toxicity in large animal models.
- Previous genetic therapy experience (e.g. Anti Sense Oligonucleotides, Cell or Gene Therapy)
- 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
- STD, LTD, Life and AD&D
- Professional development opportunities
- Team-building events
- Fully stocked kitchen
- Purple Tie dry cleaning service
- Fitness center
Encoded 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.