Therini Bio, Inc. is a biotechnology company dedicated to the research and development of novel therapeutics for the treatment of inflammatory diseases due to vascular dysfunction. Our lead program is based on novel findings by the Akassoglou lab at Gladstone/UCSF that implicate fibrin as a key driver of neuroinflammation. Therini Bio’s first clinical candidate is a monoclonal antibody targeting fibrin for the treatment of chronic inflammatory diseases and will enter the clinic in late 2022. This is a rare and exciting opportunity to be part of a growing dedicated team of drug developers and to play an essential role in the translational biology and clinical development of a first in class therapeutic. Therini has a strong investor base and experienced management team. Therini is located in Lilly Gateway Labs in South San Francisco, a new facility designed specifically for early-stage biotech companies and offers a dynamic work environment and numerous amenities. This position reports to the Chief Scientific Officer.
Therini is seeking an accomplished biomarker scientist to drive our efforts in the discovery, development, and implementation of novel translational biomarkers in neuroinflammatory and peripheral inflammatory diseases with a focus on neurodegeneration, nephrology and ophthalmology indications. The opportunity is for a scientific leader with extensive experience in and translational and clinical biomarkers to support clinical development. The successful candidate will lead the effort in building Therini’s biomarker program, driving the strategic and tactical success of biomarker deliverables including target engagement, pharmacodynamic and predictive markers and assays in collaboration with internal and external collaborators.
Roles and Responsibilities:
- Responsible for designing and implementing biomarker strategies for Therini’s clinical pipeline with a focus on assets in late preclinical development transitioning to FIH studies.
- Deliver timely and high-quality biomarker plans that are fit for purpose to Therini’s research leadership team.
- Play critical role in the development of novel assays and generate robust data to support transfer of assays to CRO’s for bioanalytical qualification for clinical studies.
- Establish and lead cross functional biomarker teams providing expertise, driving decisions as well as enabling execution
- Work closely with the clinical and regulatory teams in generating biomarker analysis plans, tracking sample disposition, tracking data transfers and QC of final data reporting to ensure performance in accordance with study protocols and regulatory needs.
- Driven, motivated and demonstrated ability to manage and mitigate timeline risks in clinical biomarker efforts.
- Ensure that they are the biomarker subject matter expert with respect to academic, novel technology, and consortia developments that support our clinical biomarker efforts.
- Experience in statistical analysis methods to drive utility of multimodal biomarker endpoints would be a plus.
- Present results, finalize scientific reports as required and help draft biomarker sections for clinical studies and regulatory submission (i.e. clinical protocols, IB, IND, and clinical study reports).
- Author and present biomarker strategies at project teams, review forums, board meetings and to external groups
- Perform other related duties as requested
Qualifications and Experience
- PhD, PharmD or MD in a relevant scientific field such as nephrology, ophthalmology, neuroscience, inflammation or immunology
- 5+ years of experience in clinical biomarkers in a biotech or pharmaceutical company setting is required
- Strong background in translational research in preclinical and clinical settings, drug development and leading teams desired
- Expertise in the development, execution and oversight of biomarker discovery, development, analysis, and data interpretation with an ability to integrate scientific and disease specific contexts for assets in clinical development
- Experience developing and outsourcing biomarker assays across a broad range of platform technologies (e.g., NGS, IHC, PCR, FISH, flow cytometry) and their clinical application
- Strong verbal/written communication skills and leadership skills needed to build relationships with key stakeholders in research and development
Why Work for Us?
- Join our vision to leverage our unique insights to novel pathways driving inflammation in the context of chronic debilitating diseases and to develop new medicines to treat patients in need
- Opportunity to translate breakthrough biological insights into innovative drugs with an innovative class of therapeutics for the treatment of numerous diseases with vascular damage
- Therini’s employees are passionate, engaged and extremely motivated to succeed in identifying novel treatments for patients suffering from neurodegenerative diseases
- Our environment is international, progressive and collaborative, our attitude is focused and pragmatic
- Therini is committed to our employees and provide robust compensation commensurate with experience and full benefits package
If you would like to be considered for an opportunity at Therini, please submit your resume with the title of the position in the subject line to email@example.com.
Therini is an equal opportunity employer.
Note to Recruitment Agencies: Please do not forward any agency resumes. Therini is not responsible for any fees related to resumes that are unsolicited.