SUMMARY OF POSITION: The Director of Clinical Science will report to the Senior Director of Clinical Development and play a critical role in supporting clinical programs, with a strong emphasis on clinical data review, data analysis, and interpretation to ensure the quality, accuracy, and integrity of the studies. The ideal candidate will bring hands-on experience in clinical science with familiarity in data management process to partner effectively with cross-functional teams as well as a background in leading and conducting natural history studies. This role requires someone who is highly detail-oriented and thrives on diving deep into complex datasets, bringing both rigor and curiosity to uncover insights that drive program success.
KEY RESPONSIBILITIES: - Provide scientific leadership for clinical programs including study, data interpretation, and reporting.
- Lead and participate in clinical data review and analysis to support data cleaning, patient safety review, and data integrity throughout the study lifecycle.
- Partner with clinical development, clinical operations, and data management to ensure high-quality data delivery.
- Contribute to data interpretation that informs clinical trial results, regulatory submissions, and publications.
- Support preparation of manuscripts, abstracts, posters, and presentations by assembling data outputs and ensuring scientific accuracy.
- Provide scientific and clinical input into study design, endpoint selection, and statistical analysis planning.
- Participate in cross-functional team meetings and act as a clinical science point of contact for internal and external stakeholders.
- Contribute to the development and review of key study documents (e.g., protocols, CRFs, data review plans, study reports, regulatory submissions).
- Support data management activities including database design input, eCRF development, and oversight of data flow.
QUALIFICATIONS: - Advanced degree in life sciences (PhD, PharmD, M.S., or equivalent preferred).
- 7+ years of experience in clinical science and/or epidemiology within the biotech or pharmaceutical industry
- Demonstrated expertise in data review, analysis, and interpretation.
- Strong understanding of clinical trial methodology, Good Clinical Practice (GCP), and regulatory requirements.
- Familiarity with data management concepts, tools, and processes (e.g., EDC, eCRF design, query management), specifically in Medidata RAVE.
- Experience with natural history studies, epidemiology studies, and real-world evidence (RWE), in oncology and/or rare diseases
- Excellent organizational skills with the ability to manage multiple priorities in a fast-paced environment.
- Strong written and verbal communication skills, with proven ability to collaborate across functions.
