Job Title: Clinical Development Scientist
Company: Skylark Bio
Location: Boston, MA
Position Type: Full-Time
About Skylark Bio:
At Skylark Bio, we are dedicated to transforming lives by eliminating sensory limitations through the development of innovative medicines. Our mission is to pioneer gene therapy solutions that address the genetic causes of hearing impairment, aiming to enhance or restore natural communication. Join us as we redefine possibilities in sensory medicine and deliver transformative therapies to patients in need.
Position Summary:
Skylark Bio is seeking a motivated and scientifically driven Clinical Scientist to support the design, execution, and interpretation of clinical trials for our gene therapy programs. Reporting to the SVP of Clinical Development, the Clinical Scientist will be a key contributor to the advancement of therapeutic programs, working at the intersection of science, medicine, and operations to bring novel therapies to patients with hearing impairment. This is a unique opportunity to utilize your audiology expertise and extend your reach from counseling local patients to aiding the global community, enhancing, or even restoring natural communication to patients enrolled in the study.
Key Responsibilities:
Clinical Trial Support:
- Contribute to the design and development of clinical protocols, investigator brochures, and related clinical trial documentation.
- Provide scientific and clinical expertise during trial execution, including input on patient eligibility, data review, and troubleshooting.
Data Analysis and Interpretation:
- Collaborate with biostatisticians and data managers to analyze and interpret clinical trial data, ensuring accuracy and relevance to program objectives.
- Translate data insights into actionable recommendations for study modifications or next-phase development.
Regulatory and Scientific Communication:
- Assist in the preparation of regulatory submissions, including INDs, clinical study reports, and responses to health authority inquiries.
- Prepare materials for scientific presentations, publications, and internal stakeholder updates.
Cross-Functional Collaboration:
- Partner with preclinical, translational science, and clinical operations teams to ensure seamless integration of scientific insights into clinical strategy.
- Support investigator and site engagement efforts, contributing to study training and scientific discussions.
Continuous Learning and Strategy Development:
- Stay informed about advances in gene therapy, hearing impairment, and clinical development methodologies.
- Provide scientific input into Skylark Bio’s clinical development strategy, aligning with the company’s mission to eliminate sensory limitations.
Qualifications:
- AuD (Doctor of Audiology) or PhD in a relevant field.
- Experience analyzing and interpreting clinical data, with a keen ability to integrate insights into actionable plans.
- Excellent written and verbal communication skills, including experience in preparing scientific and regulatory documents.
- Ability to work collaboratively in a cross-functional team environment while managing multiple priorities in a fast-paced setting.
- Passion for innovative medicine and a commitment to improving the lives of patients with sensory impairments.
To apply for this job email your details to Adam.ziegel@bio-sonder.com