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Executive Medical Director, Head of Clinical and Scientific Development

Open Position

Executive Medical Director, Head of Clinical and Scientific Development

Job Summary

The Executive Medical Director, Head of Clinical and Scientific Development reports to the Chief Medical Officer and is responsible for leading the clinical development of Elevar’s products/assets. The Executive Medical Director is a member of the Senior Leadership Team.

Job Details

  • Provides medical leadership and strategic direction to the “clinical development team”
  • Works closely with the CMO and various functional leaders (Regulatory Affairs, Clin Ops, Safety and PV, Biostatistics, Data Management, Medical Affairs, BD, Commercial, etc.) to
    develop and update the Clinical Development Plans for each asset
  • Provides medical/clinical input into the creation of protocols and all other study-related
    documents
  • Provides ongoing input into SOP gap assessments and assists with SOP creation and
    revision as requested
  • Provide medical support to investigative sites and project staff for protocol-related
    issues including protocol clarifications, inclusion/exclusion determinations, and issues of
    patient safety and/or eligibility
  • Participate in medical/safety discussions with Principal Investigators (PIs), study team
    members regulators and key opinion leaders
  • Provides oversight to the medical monitor(s) and “study teams” (internal and external) o Attend CRO/vendor “Kick-Off” meetings, weekly team meetings, and vendor meetings,
    as needed or requested
  • Provide consultation for medically related questions from participating vendors,
    affiliates, etc.
  • Participates in the development of Medical Monitoring Plans
  • Engage cross-functional internal workstreams including drug safety and
    pharmacovigilance, biostatistics, data management, clinical operations, and regulatory
    affairs
  • Participates in scientific literature review process for periodic safety reports, signal
    detection, and ad hoc as needed
  • Work closely with Regulatory Affairs, Safety and PV and other cross functional team
    members to ensure oversight of critical safety issues and benefit-risk assessments
  • Key member on the Safety Oversight Committee; presentation of safety issues, signal
    evaluations, and proposed risk mitigation strategies
  • Provide medical content and review of aggregate safety reports such as PSUR, DSUR,
    PADER, and other periodic reports
  • Oversee the preparation of new drug application safety updates, investigational new
    drug safety reports, investigator safety communications, product labeling/package
    inserts and other safety-related reports as necessary
  • Participate in the clinical safety and benefit risk sections of regulatory documents and
    preparation for meetings with regulatory and public health authorities as well as advisory committees

Candidate Requirements

  • MD or DO from accredited institution of Medical Education (Fellowship trained Oncologist, Board Certified in Oncology preferred;)
  • Active or inactive US license to practice medicine or international equivalent o Total applicable experience (clinical plus industry) minimum of 15 years
  • Completion of a US residency or ex-US equivalent and Oncology Fellowship training with at least 2 years of clinical experience beyond completion of Fellowship
  • Minimum of 10 years of experience in Clinical Development in the biopharmaceutical industry
  • Excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications
  • Strong ability to understand and evaluate technical, scientific and medical information; exposure to clinical data collection, assessment, and analysis
  • Computer skill should include proficiency with Microsoft Office suite of software
  • Proficiency in MedDRA coding, Microsoft Excel, Word, and PowerPoint; safety database
    experience preferred; ability to learn new computer systems as they are implemented o Working knowledge of global drug development and pharmacovigilance guidelines and
    regulations
  • Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet
    deadlines
  • Excellent teamwork and collaboration; proficiency in verbal and written communication o Excellent English written and verbal communication skills
  • Commitment to the highest standards of patient management, GxP, and clinical
    research

To Apply

Please send your resume and message to tommcqueeney@elevartherapeutics.com.