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Senior Director, Head of Clinical Pharmacology

$235.5k - $329.5k

Scorpion Therapeutics

THE OPPORTUNITY Vir Biotechnology is looking for an experienced Sr. Director of Clinical Pharmacology to lead the technical and operational aspects of the department in support of programs across all stages of preclinical and clinical development. Responsibilities Oversee clinical pharmacology and translational PK/PD operations and deliverables across all stages for infectious disease and oncology programs Serve as technical expert on cross-functional project teams and provide strategic input to program advancement Develop fit-for-purpose clinical pharmacology strategies to enable development and regulatory decisions from pre-IND through market authorization Select and execute PK/PD, PopPK, and exposure-response modeling/simulation to inform dose selection, optimization, and justification Author and provide technical input for regulatory documents/submissions and responses to questions (protocols, IBs, briefing packages, INDs, NDAs/BLAs) Collaborate with cross-functional teams (clinical research/operations, biomarkers, bioanalytical, biometrics, CMC, research, regulatory) Establish/manage collaborations with external vendors and partners Generate/manage departmental budget(s) and optimize resource allocation across multiple programs Manage and develop the Clinical Pharmacology and Translational PK/PD team (hiring, mentoring, capability building) Qualifications/Skills PhD, PharmD, or MD with 13+ years industry experience in Clinical Pharmacology, DMPK and/or related fields Expertise in nonclinical/clinical PK concepts; deep understanding of multidisciplinary drug development Expertise in PK/PD, PopPK, and exposure-response modeling Extensive experience leading translational and clinical pharmacology work from candidate selection through market authorization Strong understanding of regulatory requirements and experience contributing to submissions/engagements Working knowledge of bioanalytical techniques for small molecules and biologics Experience with biologics (monoclonal antibodies and bispecifics) required; oncology experience strongly preferred Proficiency with standard PK analysis and graphing programsProven ability to manage and develop teams Compensation/benefits Expected salary range: $235,500 to $329,500 per year. Eligibility Applicants must be authorized to work in the U.S.; company is unable to sponsor or take over sponsorship of an employment visa at this time. #J-18808-Ljbffr Scorpion Therapeutics

Vacancy posted 1 day ago
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