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Director, Clinical Biomarkers

About Third Harmonic Bio

Third Harmonic Bio is a biopharmaceutical company with a singular purpose: To create a breakthrough treatment for people living with severe allergy and inflammation – debilitating conditions that can take a significant toll on overall health and well-being.

We are developing a highly selective oral wild-type KIT inhibitor for millions of people living with chronic urticaria, severe asthma, and other mast cell-mediated diseases.  Despite the availability of multiple approved medicines, there is an urgent need for new treatment options.  We are grounded in our purpose of developing medicines to meaningfully improve the lives of the patients we serve.

We are seeking smart, fun, and talented individuals seeking a fast-paced environment where they can meaningfully contribute to building a successful company.

Our Values

Our values provide the foundation for our culture and our operating principles – and underly how we hold ourselves accountable and how we interact with each other, with our partners, and with the global medical and patient community.

Be Human

Relationships are important.  Bring your full self to work and create space for others to do the same.  Balance candor with empathy.

 

Own the Big Picture

Context is critical.  Ground every decision and action in the entirety of what we are trying to achieve.

 

Go THRD

We hold ourselves to a higher standard.  Work with urgency, purpose, and passion.

 

The Role

Reporting to the Senior Vice President, Clinical Development, the Director, Clinical Biomarkers will lead the implementation of THBs clinical biomarker plan  across all clinical development programs. The core of this primary role is built upon three key capabilities: collaboration with internal and external SMEs to ensure a sound and integrated biomarker strategy across development stages, stay abreast of cutting edge biomarker and bioanalytic approaches relevant to our technology and therapeutic targets, drive the key operational components of biomarker activities within trials to ensure timely and accurate results.

Responsibilities

  • Biomarker Focused:
    • Drive the evaluation, selection and development of clinical biomarker assays and vendor selection
    • Collaborate closely with the clinical development, medical, and translational science SMEs to create a core clinical bioanalytical strategy that is evidence based and uses sound biological reasoning
    • Generate specific biomarker plans for clinical trials, considering the specific disease indication, program stage, and trial design using reliable bioanalytical techniques with diagnostic or therapeutic significance and investigate new exploratory markers and methods when appropriate
    • Manage the integration of biomarker strategies into clinical trial protocols and ensure alignment with overall study objectives
    • Collaborate with Clinical Operations to ensure that sample collection, processing, and shipping adhere to regulatory and quality standards
    • Coordinate with external laboratories and vendors for biomarker analysis, ensuring timely and accurate results
    • Perform technical and strategic assessment of new and innovative biomarker approaches in the field of allergy, immunology and/or inflammation in partnership with Translational functional lead.
    • Ensure that the biomarker strategy employs bioanalytical techniques that are practical for clinical settings; using assays that are adaptable to the clinical environment, offering timely results, maintaining high sensitivity and specificity, and rely on easily accessible specimens
    • Review and interpret biomarker data, providing insights and recommendations to inform clinical development strategies
    • Stay current with advancements in biomarker technologies and immunology to continuously enhance the biomarker strategy
    • Prepare and present biomarker-related data to internal stakeholders, regulatory authorities, and external partners
  • Represent the clinical development function on select projects, providing general clinical development support:
    • Write and contribute sections of consent documents, investigator brochures, clinical study reports, abstracts, posters, manuscripts and clinical sections of key regulatory documents
    • Monitor and oversee GCP compliance with help of clinical operations and CRO / vendors / clinical trial sites

Qualifications

  • PhD in immunology, molecular biology, or related biological science field
  • 7-10 years in biotech/pharmaceutical industry, with at least, 3 years direct experience in managing biomarker-related activities in clinical trials (regulated interventional drug trials)
  • Thorough knowledge of global clinical study design and drug development process from discovery to registration and commercialization
  • Exceptional communication skills (written and verbal); comfortable presenting data to a variety of audiences; and strong cross-functional collaboration skills
  • Knowledge of GCP and ICH Guidelines

 

The salary range for this role is approximately $194,000-$220,000.

All qualified applicants will receive consideration for employment without regard to race, sex color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

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