Clinical Scientist, Director Clinical Development

Role Summary

The Clinical Scientist (CS), Director provides scientific expertise necessary to design and deliver clinical studies and is responsible for clinical activities of assigned program. This role partners with disease area heads, clinical trial physician, and clinical lead to develop scientific and clinical strategy for trials and/or programs. The CS develops study designs across phases of clinical development and ensures high-quality trial data collection, analysis, review, and reporting in accordance with Clinical Development plans. Located in Parsippany, NJ or West Chester, PA.

Responsibilities

• Provide scientific expertise to clinical studies (e.g., protocol, Key Results, Clinical Study Report)
• Lead, plan and execute study-level activities for one or more trials with minimal supervision
• Support other clinical development activities (e.g., medical review/validation of clinical data, study risk assessment)
• Contribute to protocol concept sheet, final protocol, amendments, and the clinical study report
• Contribute to the clinical parts of regulatory documents (e.g., CTD for FDA/EMA submissions) and respond to questions from health authorities
• Provide medical input and support for activities related to clinical studies (training, feasibility, medical data review, medical information for study team, investigators)
• Act as the clinical reference in the Clinical Study team related to clinical data
• Engage with investigators, site staff, CROs, and monitors to maintain enrollment and study engagement
• Assist in processing responses to medical questions raised by EC/IRBs and sites
• Review site/CRA training materials and participate in site initiation visits and Investigator meetings
• Support clinical aspects of Business Development and Licensing activities as needed

Qualifications

• Advanced degree in Life Sciences (MD, PhD, PharmD, MS, or equivalent); strong scientific background required
• Minimum 5 years of experience in clinical development within pharma or CRO, with emphasis on study design, data analysis, data review, and interpretation

Skills

• Understanding of phase I‚ÄìIII drug development, Good Clinical Practice, trial design, statistics, regulatory processes
• Ability to apply statistical analysis methods and interpret data across a study continuum
• Knowledge of Therapeutic Area (TA) preferred; ability to interpret and present trial/program data
• Strong scientific communication in English, both written and verbal
• Effective communicator with senior management and cross-functional teams
• Negotiation, conflict resolution, presentation skills, and ability to work in a matrix environment
• Self-motivated, proactive, and team-oriented

Education

• Advanced degree as listed in Qualifications

Additional Requirements

• Travel up to 20% expected