Quality Recruiting. Established Experts.

VP Clinical Development

Reference Number: 3124
Location: Remote

Our client is an emerging pharmaceutical company.  They have asked us to assist them in their search for a VP Clinical Development.

Major tasks and responsibilities will include:

  • Responsible for the strategy, planning and execution of clinical trials to ensure scientific and late-development plans are consistent with target label claims, project team and corporate goals.
  • Leads the clinical development team, including interactions with clinical operations, safety, marketing, regulatory, pre-clinical and other functions.
  • Supports and provides input into the planning, design, preparation, initiation, and execution of study protocols and other required documentation in compliance with project plans, federal regulations, and GCP.
  • Creates and manages effective internal and external relationships, with members of the DMC, CAC, SAB, CABs, CROs, regulatory agencies, partners, KOLs, etc.
  • Works closely with the CMO and clinical team in the development of program level documents, including clinical sections of regulatory documents.
  • Works with Drug Safety team members and IRB’s to troubleshoot any relevant issues, and keep team members advised of progress, issues and results.
  • Reviews relevant lab data from all studies and carefully reviews AESI and SAEs.
  • Coordinates effective compliance within Biostatistics, Clinical Development, Clinical Operations, Data Management, Medical Writing, and departments that interface with clinical study execution.
  • Contributes to interaction with the FDA and global regulatory authorities and expert bodies.
  • Responsible for implementation of integrated and comprehensive data-driven Quality Monitoring activities to ensure compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness.
  • Responsible for project planning; issues management/escalation/resolution; risk management; CRO/Vendor management; time line, budget and resource Management.
  • Develops and provides clinical science input into annual and strategic Lifecycle Plans (LCPs), Integrated Development Commercialization Plan (IDCP), annual safety reports and regulatory documents.
  • Ensures clinical projects/programs are tracked and communicates to the executive team and appropriate functional groups in a consistent and timely manner.
  • Assists with NDA/BLA compilation and management.
  • Experience in drug development with advanced understanding of other functions; including but not limited to: Research, Non-Clinical, Manufacturing / Supply Chain, Drug Safety, Medical Affairs, Commercial, Regulatory, Finance, CRO operations, and compliance practices.
  • Provides scientific and clinical expertise to a clinical development program and clinical strategies for a product to obtain regulatory approval.
  • Establishes relationships with internal colleagues and external collaborators (e.g., investigators, KOL's/CROs) and represents the company in public (e.g., scientific conferences, partners).
  • Excellent knowledge of relevant FDA regulations and guidelines for conducting clinical trials; knowledge of relevant European Union (EU), South American (SA) and Asian regulations also a must.
  • Experience in interactions with FDA as well as regulators in the EU, SA, and Asia important.
  • Must be science-and data-driven.
  • Demonstrates knowledge of quality assurance related to clinical trial implementation.

We seek candidates with the following qualifications:

  • MD (Board Certified Cardiology, Endocrinologist, Internal Medicine or related) required.
  • Clinical practice experience preferred, and sub specialization in a relevant therapeutic area (Cardio/Metabolic) is highly desirable.
  • Significant experience in leadership role(s), which involved clinical development and operation in the pharmaceutical industry and drug development.
  • Demonstrated career progression.
  • Experience with Phase III and international regulatory submissions in terms of INDs, CTAs, End-of-Phase 2 meetings and NDAs/BLAs/MAAs is needed.
  • Must have a results-oriented work ethic and a positive, can-do attitude.
  • Effective leadership, people management, communication skills and a team building management style are essential; must be willing and able to be “hands on” and willing to roll up sleeves and delve into details.
  • Must have the highest personal values and ethical standards.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3124. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.