- Job Type: Full-Time
- Function: Clinical Research
- Industry: Biotechnology
- Post Date: 11/26/2023
- Website: www.remixtx.com
- Company Address: 100 Forge Rd, Watertown, MA 02472, US
About Remix TherapeuticsRemix launched in 2020 with a vision to transform patient's lives through modulation of RNA processing.
At Remix, we are reprogramming RNA to transform patients’ lives. RNA processing is the pathway occurring after DNA transcription and controls the production of mature mRNA and protein expression. At Remix Therapeutics we are developing therapies to co-opt and reprogram this pathway to treat undruggable disease. Our proprietary REMaster technology platform enables the identification of compounds that alter RNA processing and correct dysregulation or eliminate deleterious genes altogether. The Remix team includes drug development experts who are committed to advancing this new modality with the potential for impact across a broad range of diseases. We are a group of driven, talented people committed to scientific rigor and inclusion.
We seek a highly motivated, experienced clinical translation operations leader to join our team located in Watertown, MA. As a clinical translation operations leader reporting to the Head of in silico and in vivo biosciences, this person will develop and implement the clinical biomarker strategy, operations and logistics with a cross-functional team of scientists and clinical experts to ensure the execution of the development of novel RNA processing medicines. The ideal candidate will have a strong background in biomarker regulations and operation and will be driven to succeed within a hypothesis-driven, team-oriented, and interdisciplinary biotech environment. The individual will be expected to contribute to all stages of drug development, advancing the clinical biomarker programs starting from preclinical stage all the way to marketing.
Principal Duties and Responsibilities
- The desired candidate will work with stakeholders within the project team and cross-functionally with partners in Translational team, Clinical Operations, Clinical Pharmacology, Quality, Bioinformatics and Clinical Data Solutions to develop and implement the clinical biomarker strategy, operations and logistics with multiple external vendors thereby necessary to contribute to the development of ground-breaking new RNA processing medicines
- The clinical biomarker operations will be accountable for robust clinical biomarker operational planning and execution for clinical programs starting from preclinical stage all the way to marketing
- Provides clinical bioanalytical operational leadership, and if needed, operational oversee for Companion Diagnosis (CDx) development
- Coordinates with the clinical study team and delivers biomarker specimen and testing strategy in accordance with the requirements of quality, and ethical and regulatory standards, including ICH/GDPR/GCP/GLP
- This position requires a combination of scientific and project management expertise as they will be responsible for the support of clinical laboratory functions within clinical trials; Includes operational support for biomarker clinical testing schedules, and lab manual creation.
- Reviews and provides input into clinical study protocols, informed consents and central laboratory documents to ensure accurate and precise operationalization of biomarker strategies
- Functions as key point of contact for multiple biomarker testing vendors and maintain oversight of biomarker vendor performance, issues, their resolution and coordinates any corrective action with the QA teams
- Works effectively in a dynamic operational environment with cross-functional stakeholders
- BS, MS or PhD in Biochemistry, Biology, or related pharmaceutical sciences
- A total of 10+ years of relevant work experience in drug development, sample/biospecimen management or translational research
- Deep knowledge of clinical trials and understanding of the role of biomarkers in clinical studies
- Working knowledge of FDA & ICH/GCP regulations and clinical laboratory specimen handling
- Leadership skills and demonstrated ability to collaborate with a diverse group of scientists, clinicians, vendor labs, internal and external teams to support clinical development strategy
- Strong attention to details, timelines and quality
- Works successfully under pressure with tight timelines
- Proven critical reasoning skills including the identification and resolution of complex problems
- Eager to grow and develop capabilities
Remix values diversity and is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, marital or veteran status, genetic information, sexual orientation or any other legally protected status. Remix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Note to Third Party Staffing Agencies: Please do not forward any agency resumes. Remix Therapeutics is not responsible for any fees related to resumes that are unsolicited.