Senior Director, Clinical Pharmacology

  • Location:Cambridge, MA
  • Department:Clinical
  • Type:Full Time
  • Min. Experience:Executive

 

Covid- 19 Mandatory Vaccination Requirement

Throughout the pandemic, we’ve done all that we can to keep our employees safe, and the employees coming in have been careful to take precautions to reduce the risk of bringing Covid into our work environment. As we reopen our office, we’re mindful that the pandemic is not yet over, and young children are not yet vaccinated. We are committed to continuing to protect our team and keep our office safe.  Vaccination has proven to be the best thing you can do to protect yourself, your family, your colleagues and your community. Since we are striving for a 100% vaccinated workplace (including employees, contractors, vendors and guests), all NEW HIRES will be required to be fully vaccinated, and to present proof of their Covid-19 vaccination to our HR team as part of our on-boarding process.

 

RESPONSIBILITIES:

  • Accountability for the clinical pharmacology strategy for Surface Oncology’s development portfolio, including design, implementation, and execution of program specific clinical pharmacology studies, data analyses, 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/safety, and PKPD 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 and validation, biomarker selection and generation of program specific integration analysis plan and CRO selection/management
  • Represent clinical pharmacology and justify clinical pharmacology development strategy during meetings and discussions with regulatory authorities
  • Draft and review 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
  • Lead and provide mentorship to more junior clinical pharmacology colleagues as Surface Oncology’s corporate needs evolve

 

EDUCATION AND EXPERIENCE: 

  • MD and/or PhD in pharmaceutical sciences/pharmacology or PharmD with at least 7 years of relevant clinical pharmacology experience within the pharmaceutical and biotechnology industry
  • Experience in oncology drug development and understanding of the oncology regulatory environment
  • Hands-on PKPD modeling experience including first-in-human modeling, quantitative system pharmacology (QSP), exposure/safety/response modeling and population PK modeling.
  • 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