Director Clinical Pharmacology Bioanalytical

Director Clinical Pharmacology Bioanalytical

Requirements

• Ph.D. in Chemistry, Biochemistry, Pharmacology, or a related field
• Targeting 10 years’ relevant experience in the pharmaceutical industry
• Proven track record in assay development, validation, and troubleshooting
• Strong understanding of regulatory guidelines (e.g., FDA, EMA) related to bioanalysis
• Excellent communication and interpersonal skills
• Proven ability to work effectively in a team-oriented environment and present complex information clearly and effectively
• Demonstrated ability to successfully interact with internal staff and manage external bioanalytical vendors, including CROs
• Strong foundation in preclinical and clinical pharmacology with working knowledge of cross-functional interfaces that are important for efficient drug development
• Ability to work independently, take initiative and complete tasks to deadlines
• Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
• Ability to think creatively and strategically, with strong problem-solving skills
• Highly motivated with a passion for drug development
• Ability to effectively present information to leaders, external contractors and employees at all levels of the organization
• Ability to learn, understand and apply new technologies, strategies and approaches that enhance the team’s ability to achieve goals and meet timelines/deliverables
• Ability to travel on occasion

Responsibilities

• Establish bioanalytical and biomarker assay development strategies to support context of use
• Work effectively within cross-functional team environments, conceive and communicate strategy and reduction to practice
• Design, develop, and validate bioanalytical and biomarker assays, including ligand binding assays (e.g., ELISA, MSD) and mass spectrometry-based assays (e.g., LC/MS)
• Oversee the execution of bioanalytical studies, ensuring compliance with GLP/GCLP regulations
• Analyze and interpret bioanalytical data, providing scientific insights and recommendations
• Establish and manage productive relationships with external CROs and ensure timely delivery of high-quality data
• Prepare and review technical reports, standard operating procedures (SOPs), and regulatory submissions
• Stay current with advancements and innovations in bioanalytical and biomarker technologies and regulatory requirements
• Act as a subject matter expert at bioanalytical compliance and regulatory audits
• Perform other duties as assigned

Preferred Qualifications

No preferred qualifications provided.