Director - Clinical Pharmacology

Skills Alliance has been retained by a Seattle-based startup focused on developing dual-payload Antibody Drug Conjugate (ADC) treatments in the oncology space. This company is backed by the industry’s top investors, and raised nearly $200 Million last year.

Right now, they are focused on driving dual-payload ADCs into clinic and are looking for a Clinical Pharmacology leader to support these efforts.

• Primarily focus on clinical pharmacology and biomarker development, and specifically their implementation into clinical development efforts.
• Lead Clinical Pharmacology strategy and execution, including PK and ADA method development, PK/PD modelling, Clinical Sample Analysis, Dose Justification, Safety Margin Assessments, etc.
• Contribute to regulatory submissions (draft/review relevant sections for IND, CTA, NDA/BLA).
• Work closely with vendors as needed to ensure success on Clin Pharm duties.

• 5+ years of Clinical Pharmacology experience, including multiple years in a position driving strategy and execution.
• Antibody Drug Conjugate (ADC) experience OR extensive background with both large and small molecule assets.
• Proven ability in developing and implementing biomarker strategies, including assay development, validation, and incorporation into clinical trials for patient selection and PD assessments.
• Experience with vendor management, regulatory submissions (IND, CTA, NDA/BLA), and participation in health authority interactions.