Director/VP, Clinical Development

Company: Michael Page US
Location: Somerville
Posted on: April 6, 2021

Job Description:

Pre-IPO biotech company looking for an experienced Medical Director/VP Responsible for developing and executing the clinical strategies for assets About Our Client Pre-IPO biotech company looking for an experienced Medical Director/VP Job Description MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants. Description

• Lead clinical strategy while working to ensure cross-functional alignment on an ongoing basis throughout the phases of clinical development. Design study protocols and clinical development plans in collaboration with functional area and development teams.
• Provide medical/scientific, strategic, and operational expertise and support for the planning and execution of IND filings, early and late stage clinical trials.
• Conduct medical monitoring of clinical trials; writes protocols, informed consent documents; respond to questions from regulatory agencies, institutional review boards and ethics committees; review clinical data, case report forms and ensure final accuracy of clinical trial data for clinical study reports.
• Institute and continuously improve operating procedures ensuring best practices.
• Establish appropriate strategic partnerships with centers of excellence, advocacy groups and KOLs in the areas of scientific interest.
• Collaborate closely with key stakeholders to ensure strategic integration of product development plans and strategies.
• Plan and develop content for advisory meetings with key opinion leaders
• Participate in review of medical materials to ensure content is medically appropriate and compliant with internal and external requirements.
• Proactively identify clinical development risks and propose risk mitigations.
• Keep up to date on current relevant therapeutic areas through familiarity with literature, attendance at meetings, conventions, and professional associations. The Successful Applicant
  • MD, MD/PhD with 10-15 years of industry experience or equivalent experience in academic clinical trial management. Specialty training in medical oncology or equivalent highly preferred
  • Prior clinical experience in phase 1-3 studies in oncology as clinical investigator or monitor/clinical director
  • Comprehensive understanding of the drug development process and a proven track record of success in executing development programs
  • Understanding of clinical regulatory requirements; experience in driving successful regulatory interactions preferred. Working knowledge of ICH guidelines, relevant regulatory guidance, and GLP, GMP and GCP procedures.
  • Expertise in biomarker development, validation and utility and continued engagement in nonclinical and clinical biomarker development and implementation.
  • Strong focus on finding innovative ways to promote exploratory technologies and methodologies, leverage external expertise and funding, and pursue adjacent scientific areas if appropriate.
  • Successful track record in planning, conducting and publishing of discovery and/or clinical science. What's on Offer Excellent salary and benefits package with equity component once public We have updated our Privacy Policy *These updates apply to everyone who uses or accesses this site. Please review the policy carefully. If you continue to use or access this site, you do so under the new Privacy Policy.
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