锦鲤求职岗位描述
We are seeking an experienced and strategic Head of Clinical Pharmacology to lead and oversee clinical pharmacology and ADME sciences for a rich pipeline spanning innovative drug modalities—including mRNA in vivo CAR-T, mRNA cancer vaccines, small molecules, antibodies, and bispecific antibodies. This role will tailor clinical pharmacology strategies to the unique characteristics of each modality, shape scientific direction from early discovery through late-stage development, drive rigor and operational excellence, build a high-performing team, and partner cross-functionally to accelerate the development of transformative therapies for patients.
Key Responsibilities
• Establish and refine clinical pharmacology and ADME capabilities tailored to the distinct needs of diverse drug modalities (mRNA in vivo CAR-T, mRNA cancer vaccines, small molecules, antibodies, bispecific antibodies), to support discovery and early development projects across multiple therapeutic areas.
• Develop and execute clinical pharmacology strategies in collaboration with internal and external partners to advance drug candidates in an efficient and scientifically rigorous manner.
• Lead clinical pharmacology projects from discovery to FIH, early and late-stage development and be responsible for the design, execution, analysis, interpretation, and reporting of clinical pharmacology related studies.
• Lead population PK/PD modeling and simulation to inform dosing strategies, study design, and regulatory decisions
• Recruit, lead and develop a team of clinical pharmacologists. Provide oversight for work conducted by CROs.
• Collaborate with both internal and external stakeholders in various projects and regulatory interaction related to clinical pharmacology data.
• Actively participated in due diligence activities when needed.
• Supports other projects as assigned.
Recommended Education and Key Competency
Education: PhD in Clinical Pharmacology, Pharmacology, Pharmaceutical Sciences, or a related discipline.
Experience:
• Minimum 12+ years of progressive clinical pharmacology experience in pharmaceutical or biotech industry, with a proven track record in leading ClinPharm for diverse drug modalities.
• Demonstrated experience in leading population PK/PD modeling and simulation, and managing ClinPharm projects from discovery to late-stage development and regulatory submissions.
• Proven people leadership experience, including recruiting, developing, and leading a team of clinical pharmacologists; experience overseeing CRO activities is essential.
• Strong regulatory knowledge and experience in interacting with global regulatory authorities (e.g., FDA, CDE) on clinical pharmacology matters.
• Experience in due diligence activities and cross-functional collaboration across R&D, clinical, and regulatory teams.
• Excellent scientific, analytical, communication, and project management skills; ability to drive innovation and scientific excellence in a fast-paced environment.