Surface Oncology

Director, Clinical Pharmacology

RESPONSIBILITIES:

  • Accountability for the clinical pharmacology strategy for Surface Oncology’s development portfolio, including design and implementation of program specific clinical pharmacology studies, data analysis, internal decision points, and external regulatory interactions
  • Manage and be accountable for pharmacokinetic, pharmacodynamic, drug interaction, and anti- drug antibody data for all clinical trials
  • Work closely with cross functional teams and be the subject matter expert in quantitative clinical pharmacology, non-clinical pharmacology, and non-clinical modeling to determine FIH dose and schedule
  • Contribute to program strategy, study design, protocol preparation, study execution, data review/analysis, study reports and regulatory document preparation
  • Work closely with research and development teams and provide input into assay development, CRO selection and CRO management
  • Represent nonclinical and clinical pharmacology during meetings and discussions with regulatory authorities
  • Create or guide nonclinical and clinical pharmacology summary documents
  • Review literature and peer-reviewed publications to keep apprised of global regulatory developments in clinical pharmacology
  • Maintain a high standard for good laboratory and clinical practices, compliance, and ethical standards

 

REQUIREMENTS/QUALIFICATIONS:

  • MD and/or PhD in pharmaceutical sciences/pharmacology or PharmD with at least 7 years of relevant nonclinical and clinical pharmacology experience within the pharmaceutical and biotechnology industry
  • Experience in oncology drug development and understanding of the oncology regulatory environment
  • Demonstrated experience in writing, presenting, and discussing nonclinical and clinical pharmacology with both internal and external stakeholders, including regulatory authorities
  • Strong analytical skills and ability to interpret complex nonclinical and clinical data sets coupled with excellent written and verbal communication skills
  • Proven ability to work in cross-functional teams and manage multiple projects, engaging subject matter experts across functions to drive the execution of programs
  • Ability to thrive in a fast-paced, evolving company which values community, courage, and integrity

 

 

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