Stoke is seeking an enthusiastic, collaborative, and experienced Biomarker Development Scientist to join the Bioanalytical, DMPK and Biomarker Development group. The candidate will be responsible for biomarker discovery, assay development and implementation.
- Support clinical biomarker discovery efforts to inform target engagement and pharmacodynamics in patients.
- Evaluate a variety of platforms including immunoassays and LCMS and implement “fit for purpose” assays, as necessary.
- Collaborate with clinical operations to ensure biomarker testing and data generation is compliant with all regulatory requirements in clinical studies.
- Participate in clinical biomarker sub team that includes representatives from research, pharmacology and DMPK functions.
- Develop high-quality assays to quantitate biomarkers in biofluids in preclinical and clinical samples, interpret results and report data to support biomarker discovery efforts.
- Characterize/evaluate critical reagents including protein reference materials, antibodies, and reagents to ensure quality and stability.
- Work with CRO laboratories to transfer, qualify/validate bioanalytical assays, and support assay implementation.
- Prepare protocols and standard operating procedures (SOPs).
- Present results at cross-functional team and lab meetings.
- Maintain accurate documentation of experiments in ELN.
- Help maintain the bioanalytical lab and keep the instruments running properly.
Required Skills & Experience:
- Ph.D. with a minimum of 2 years of relevant experience working in the industry.
- Good understanding of bioanalytical and biomarker assay development, validation, and implementation.
- Proven hands-on experience in biomarker discovery and development using a variety of platforms e.g. qPCR, Western blots, LCMS, MSD-ECL, Luminex, Singulex, Simoa/Quanterix etc.
- Excellent problem-solving skills and ability to work as a team player in a dynamic environment.
- Excellent communication and presentation skills required.
- Proficient in standard Microsoft Office tools: Word, Excel, and PowerPoint.
- Strong attention to detail and organizations skills.
- Familiarity with regulatory expectations (FDA and EMA) and industry’s best practices in validation of biomarker assays is highly desired.
- Prior drug development experience in nucleic acids-based therapeutics is a plus.
- Prior experience in testing biological matrices for PK/PD evaluation is a plus.
Benefits & Compensation:
Stoke Therapeutics offers comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Primary Caregiver Leave; a 401K program with company match, and an Employee Stock Purchase Program (ESPP). Compensation will be highly competitive for the industry and directly commensurate with experience.
Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is based in Bedford, MA.
Since March 2020, Stoke’s office-based employees have been working from home and we have modified our business practices (including but not limited to curtailing or modifying employee travel, moving to partial remote work, and cancelling physical participation in meetings, events and conferences). We are continually assessing the impact of COVID-19 on our business and keeping in mind the best interests of our employees, patients, and business partners. For the foreseeable future, we anticipate the individual in this role will work from home and participate in meetings and company events virtually. At some point, we anticipate this role will return to working at one of our physical locations.