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VP Clinical Development Immunology/Respiratory

Reference Number: 2782
Location: East Coast USA

Our client is a major global healthcare company.  They have asked us to assist them in their search for a VP Clinical Development Immunology/Respiratory.

The VP Clinical Development Immunology/Respiratory is accountable for the design, execution and delivery of late phase and transition phase Clinical programs within the GMed (to time, quality, budget and objectives).  This role has responsibility for articulating, communicating and implementing the medical strategy for the GMed and is responsible to the GMed head for the overall quality of the clinical benefit/risk/value assessment which influences significant investment decisions.  The VP Clinical Development Immunology/Respiratory has line management responsibility for the physicians and scientists within the GMed who work on our client’s late phase programs.  In certain circumstances, the VP Clinical Development Immunology/Respiratory may be expected to directly participate in Project activities.

Major tasks and responsibilities will include:

  • Accountable for the design, execution and delivery of late phase Clinical programs within the GMed to time, quality, budget and objectives.
  • Accountable for innovative design, execution and interpretation of clinical trials that will deliver successful registration, differentiated product opportunities and provide value in the market place.
  • Accountable for the scientific quality of the work delivered from the Late Phase Clinical Project Teams.
  • Ensures execution and delivery of clinical development programs that will identify and answer key questions for individual product development plans as effectively and confidently as possible aligned with the Target Product Profile and ensure that these are effectively represented at health authorities and payors, in a patient focused way.
  • Ensures the design and execution of clearly articulated clinical plans that demonstrate the benefits, risks and value of compounds in late phase development and into LCM, as part of 'value maximization' including incorporating elements of Personalized Healthcare, where applicable.
  • Accountable for the benefit-risk assessment of all compounds and ensuring appropriate human subject protection, in collaboration with the Chief Medical Officer and the Patient Safety and Regulatory functions.
  • Accountable for clinical support for US local and marketing company needs as required.
  • Accountable for ensuring consistent practices with the highest ethical standards, compliance with internal SOPs, local regulations and laws.
  • Line management responsibility for the Medical Science Directors (medical leads).
  • Responsible for representing clinical development in TA Disease Area discussion - strategic influence on choice of disease areas, disease segments, molecular pathobiology and targets.
  • Ensures that Project Clinical Development strategies and plans receive broad challenge and peer review to assure high scientific quality and cost effectiveness, including chairing relevant Clinical Challenge sessions.
  • Active contribution to assigned licensing or externalization activities ensuring appropriate medical and scientific input to assigned projects, including in collaboration with the licensing medical director if applicable provision of a consolidated Clinical view on external opportunities.
  • Interaction with Clinical leaders from the early science units, both large and small molecule.
  • Ensures smooth clinical transition of products from phase II into phase III.
  • Recruitment of internal and external clinical talent to support capabilities.
  • Develops, coaches, mentors, retains, motivates and inspires individuals in their group.
  • Responsibility for the delivery of Clinical Development activities for those direct project activities assigned, in either an MSD or Project Physician role.
  • Chair of GMed Clinical Challenge and Protocol Review, key review committees for progressing clinical programs in anticipation of governance interactions.
  • Responsible for managing resources (budgets and headcount) across assigned teams.
  • Facilitation of knowledge sharing between team members and across project teams.
  • When requested, attends Late Stage Product Committee or other senior management committee meetings for specific Clinical Development Project activities.

We seek candidates with the following qualifications:

  • M.D. required.
  • Specialty training or board eligibility in an area relevant to the Immunology/Respiratory preferred.
  • Demonstrated clinical research expertise and experience.
  • A scientific track record in the clinical therapy area of relevance supported by peer-reviewed publication record.
  • Demonstrated leadership experience.
  • Significant specific international Drug Development experience with emphasis on Phase III (development for launch).
  • Experience in writing, reviewing/editing and/or defending Regulatory Dossiers (NDAs, MAAs, JNDAs).
  • Experience representing major development projects at Regulatory Agencies in North America, Europe or Asia.
  • Experience in actively collaborating with major markets in communicating with local network and commercial organizations, accessing receiving and validation the science as locally relevant and available, placing global R&D activities accounting for the relevance of markets.
  • Proven teamwork and collaboration skills.
  • Demonstrated ability to lead senior level medical and scientific staff.
  • Excellent communication skills.
  • Ability to set and communicate a strategic vision.
  • Strong coaching skills and an appreciation of how clinical development contributes to the broader business.
  • Willingness to travel nationally and internationally.


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 2782. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.