Dir./Sr Dir.- Clinical Assays/Bioanalytics

Job Title:

Director / Sr Director-Bioanalytics/Clinical Assays

Reports to (title):

Head of Research, Translational Development

Solid Summary:

Solid Biosciences is a life science company focused on advancing a portfolio of neuromuscular and cardiac programs, including SGT-003, a differentiated gene therapy candidate for the treatment of Duchenne, AVB-401, a gene therapy program for the treatment of BAG3 mediated dilated cardiomyopathy, AVB-202-TT, a gene therapy program for the treatment of Friedreich’s Ataxia, and additional assets for the treatment of fatal cardiac diseases. Solid aims to be the center of excellence across a given disease spectrum bringing together those with expertise in science, technology, disease management, and care. Patient-focused and founded by those directly impacted, Solid’s mandate is to improve the daily lives of patients living with these devastating diseases.

Position Summary:

The Director/Senior Director of Clinical Assay Development (Bioanalytics) will lead and oversee the design, development, validation, and implementation of bioanalytical assays to support clinical programs. This role is responsible for ensuring that all assays used in clinical studies, including pharmacokinetic (PK), pharmacodynamic (PD), immunogenicity, and biomarker assays, are scientifically robust, regulatory-compliant, and aligned with clinical and regulatory needs. The Director will collaborate closely with R&D, clinical operations, regulatory affairs, and external partners to ensure that the assays support the company's programs across neuromuscular diseases and cardiomyopathies.

The ideal candidate will have extensive experience in bioanalytical assay development and validation, a strong understanding of gene therapy modalities, and a proven track record in leading cross-functional teams in a dynamic, fast-paced environment.

Key Duties & Accountabilities:

1. Assay Strategy Development: Develop and execute the bioanalytical assay strategy for clinical programs, ensuring that all assays meet clinical, regulatory, and scientific requirements.
2. Validation and Regulatory Compliance: Ensure that bioanalytical assays are validated according to relevant regulatory guidelines (FDA, EMA, etc.) and Good Laboratory Practices (GLP), providing assay documentation to support regulatory submissions (e.g., INDs, BLAs).
3. Cross-functional Collaboration: Collaborate with clinical, regulatory, quality, and manufacturing teams to ensure the seamless integration of bioanalytical data into clinical development plans. Provide bioanalytical expertise to guide clinical study design and data interpretation.
4. External Partnerships: Manage relationships with external partners, including contract research organizations (CROs) and academic institutions, to ensure that outsourced bioanalytical activities are executed to the highest standards.
5. Data Management and Reporting: Oversee the generation, interpretation, and communication of bioanalytical data to internal teams and regulatory authorities. Ensure the timely delivery of high-quality bioanalytical reports for clinical trial decision-making.
6. Innovation and Technology Integration: Stay abreast of emerging bioanalytical technologies, particularly those relevant to gene therapy, and drive the implementation of new techniques and platforms to enhance assay sensitivity, specificity, and throughput.
7. Budget and Resource Management: Manage budgets, timelines, and resources related to bioanalytical assay development, ensuring that programs remain on schedule and within financial constraints.

Core Competencies Required:

1. Communication: Excellent communication and presentation skills, with the ability to convey complex bioanalytical concepts to cross-functional teams and external partners.
2. Technical Expertise: Deep expertise in bioanalytical assay development, with a specific focus on assays used in gene therapy clinical trials (e.g., vector biodistribution, transgene expression, immune response assays).
3. Regulatory Knowledge: Thorough understanding of regulatory requirements (FDA, EMA, ICH guidelines) for clinical bioanalytics, including experience preparing bioanalytical components for regulatory submissions.
4. Problem Solving & Decision Making: Strong critical thinking and problem-solving skills, with the ability to make data-driven decisions in a fast-paced, high-stakes environment.
5. Collaboration & Teamwork: Demonstrated ability to work effectively in a collaborative, cross-functional environment, driving alignment between R&D, clinical, regulatory, and external stakeholders.
6. Adaptability & Flexibility: Ability to navigate the dynamic and evolving field of gene therapy, with a flexible approach to incorporating new scientific developments and regulatory updates.

Knowledge: Education, Experience, & Skills:

Education: PhD in Biochemistry, Molecular Biology, Immunology, or a related discipline. A Master’s degree with extensive relevant experience may also be considered.

Experience:

• Minimum of 8-10 years of experience in bioanalytical assay development and validation, preferably within the biotechnology or pharmaceutical industry.
• Experience working in gene therapy or cell therapy, with a deep understanding of bioanalytical needs specific to these modalities.
• Proven track record of leading bioanalytical teams and developing assays to support clinical trials from early-phase through late-stage development.

Technical Skills:

• Expertise in bioanalytical techniques such as ELISA, PCR-based assays (qPCR, ddPCR), flow cytometry, immunoassays, and molecular biology techniques.
• Familiarity with gene therapy-specific assays, including those for vector biodistribution, transgene expression, and immune response.
• Proficiency in assay validation under GLP/GCLP conditions and experience with regulatory interactions regarding assay development and validation.
• Regulatory and Compliance Knowledge: In-depth knowledge of regulatory guidelines for bioanalytical method validation and clinical bioanalytics, including FDA, EMA, and ICH guidelines.
• Collaborative Mindset: Demonstrated success in working cross-functionally, with strong relationships across R&D, clinical development, regulatory, and manufacturing teams.

Travel Commitment:

• As needed

Role Location:

Hybrid