Associate Director of Translational Assays - Valid8 Financial : Job Details

Department: Translational Research

Position Summary:

TCG Labs-Soleil is seeking an experienced and innovative Associate Director of Translational Assays to lead the development, validation, and deployment of Pharmacokinetic (PK), Anti-Drug Antibody (ADA), biomarker and pharmacodynamic (PD) assays to support clinical programs across multiple therapeutic areas. This individual will play a critical leadership role in bridging discovery, preclinical research, and clinical development by developing and implementing assay strategies that inform pharmacokinetics, mechanism of action, target engagement, and patient response. The ideal candidate brings deep scientific expertise, strategic vision, and a track record of success in managing complex bioanalytical efforts, particularly for biologics and immunotherapies.

Key Responsibilities:

• Lead the design and implementation of translational assay strategies, including PK, ADA, clinical PD and biomarkers, to support early-stage clinical programs.
• Oversee assay development and validation across multiple platforms, including flow cytometry, immunoassays (ELISA, MSD), multiplex cytokine profiling, qPCR, and functional cell-based assays.
• Manage external partnerships with CROs and clinical labs, ensuring high-quality data generation in accordance with regulatory and scientific standards (GLP/GCLP where applicable).
• Collaborate with cross-functional teams including Nonclinical and Clinical Development, Regulatory, Discovery Research, to integrate assay results into program decision-making.
• Support regulatory filings (e.g., IND, CTA, BLA) through authorship and review of assay validation reports, sample analysis summaries, and regulatory response documents.
• Serve as a scientific lead in regulatory interactions, clinical advisory meetings, and internal governance.
• Drive innovation in assay technologies and translational strategies to support biomarker-based patient stratification, and real-time clinical decision support.

Qualifications:

• PhD in immunology, pharmacology, molecular biology, or related field with 8+ years of relevant biotech/pharma experience; or MS with 12+ years' experience.
• Demonstrated leadership in developing and managing clinical PK, PD and biomarker assays, preferably in oncology and immunology
• Expertise in flow cytometry, ligand binding assays, cytokine/chemokine analysis, and functional immunoassays.
• Experience with GLP/GCLP assay validation, clinical sample handling, and regulatory submission support.
• Proven ability to lead cross-functional scientific efforts and align assay development with clinical and regulatory goals.
• Strong project management and communication skills, with the ability to distill complex data into actionable insights for clinical teams.
• Preferred experience supporting first-in-human and translational biomarker strategies.
• Preferred experience with immunogenicity, PK/PD analyses, and integration of multi-omic data.
• Preferred experience in biotech startup environments with demonstrated adaptability and innovation.

Company Overview TCG Labs-Soleil, established in partnership with The Column Group , a science-focused venture capital firm, is pioneering a novel ‘venture capital-biotech' model. Our core mission is to efficiently translate scientific insights into therapeutic solutions for patients facing serious diseases. This model supports scientific entrepreneurs from the initial idea to clinical proof of concept (PoC) by combining a dedicated fund (TCG Labs) with our independent, evergreen R&D center led by a top-tier scientific team (Soleil). Together, we create an integrated ecosystem that fosters the development of single-asset portfolio companies, strategically poised for transacting after clinical PoC.

EEO Statement TCG Labs-Soleil is an Equal Opportunity Employer. We do not discriminate against qualified applicants based upon any protected group status, including but not limited to race, religion, color, creed, sex (including breastfeeding and related conditions), gender identity/gender expression, pregnancy (including childbirth and related conditions), national origin, ancestry, age, marital status, military or veteran status, sexual orientation, genetic information, physical or mental disability or medical condition as defined by applicable equal opportunity laws. Any request for accommodation can be directed to [email protected].

Benefits and Compensation TCG Labs-Soleil provides a competitive benefits package that includes access to Medical, Dental, and Vision Insurance, Life Insurance, Short and Long Term Disability, Health Savings Account (HSA), Flexible Spending Accounts (FSA), 401k plan and PTO.

The anticipated salary range for fully qualified candidates applying for this role will be $154,000 - $275,000 annually (not including discretionary bonus, equity, and benefits). The final salary offered will be dependent on several factors that include but are not limited to relevant previous experience including duration and type of experience within the industry, education, and internal equity.

Staffing Agencies TCG Labs-Soleil does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn't have a signed agreement with TCG Labs-Soleil. Please do not send agency CVs/resumes through TCG Labs-Soleil website or TCG Labs-Soleil Employees. Inquiries must be sent to [email protected] with the Subject Heading: Staffing Agency Request.