Position Overview

The Associate Scientific Director, Clinical Development, serves as a Clinical Scientist and may act as a delegate of the Therapeutic Area Lead or Medical Director for clinical development programs. This role ensures patient safety, compliance with company policies, and adherence to Good Clinical Practice (GCP) guidelines and regulations. Collaborating with cross-functional teams, this position supports the design, execution, and data interpretation of global clinical trials.

Key ResponsibilitiesCore Clinical Development Duties:Design and interpret clinical trial data, supporting program objectives.Ensure compliance with protocols, company SOPs, ICH GCP, and regulatory standards.Partner with Therapeutic Area Lead/Medical Director to ensure participant safety.Lead and prepare information for external and internal meetings, such as investigator meetings, governance reviews, and regulatory interactions.Develop clinical trial documentation, including protocols, statistical analysis plans, and clinical study reports.Author and review regulatory reports, safety updates, and IND submission documents.Operational & Cross-Functional Collaboration:Contribute to the oversight of Principal Investigators and study quality.Engage in recruitment, enrollment, and retention strategies for study participants.Collaborate with medical monitors and CROs to ensure appropriate safety documentation.Provide input on regulatory submissions based on clinical trial data.Partner with departments such as Regulatory Affairs, Medical Affairs, Pharmacovigilance, and Legal to support clinical trial execution.Participate in preclinical and all phases of clinical study conduct to ensure alignment.Additional Responsibilities:Maintain expertise in GCP, relevant global regulations, and assigned therapeutic areas.Contribute to SOP and policy development related to regulatory changes.Participate in initiatives to maximize efficiencies and cost savings in clinical trials.Mentor junior team members and cross-functional colleagues.QualificationsEducation & Experience:Bachelor’s degree required; advanced degree in life sciences or healthcare (PhD/MD/PharmD/MPharm/MSc) preferred.Minimum of 10 years of clinical research experience within pharmaceutical or CRO settings.Skills & Knowledge:Strong understanding of GCP, clinical trial regulations, and ethical standards.Proficient in clinical trial documentation and data interpretation.Experience collaborating with cross-functional teams.Excellent organizational and communication skills.Regulatory ComplianceAdhere to company policies and ethical codes of conduct.Maintain compliance with GCP, clinical trial regulations, and company SOPs.Uphold confidentiality and integrity in all aspects of the role.