Chief Medical Officer

New Jersey
4532
Our client is a clinical stage biotech company. They have asked us to assist them in their search for a Chief Medical Officer.  

Major tasks and responsibilities will include:
  • Directs the development of clinical strategies and plans for the company, including working with the management team to identify indications where the platform has the greatest potential for success.
  • Directs the clinical facets of regulatory strategies and communications with the FDA.
  • Supervises CROs and company employees, concentrating on the clinical development of the pipeline.
  • Leads the analysis and interpretation of clinical trial data and the reporting of clinical trial results.
  • Heads interactions with thought leaders, investigators, cooperative groups, and other stakeholders.
  • Delivers clinical support and works with other members of the management team to develop and communicate the overall corporate strategy.
  • Represents the company and its programs to external audiences, including the investment, medical, and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners.

We seek candidates with the following qualifications:
  • MD with Board Certification in hematology/oncology is required.
  • Must have 15 years of experience in treating patients and industry experience working on investigational new drugs.
  • Requires several years of management experience heading a clinical group including clinical/medical affairs and clinical operations.
  • Must have an established success record in Phase I-III clinical research studies and trial design as well as the successful submission of IND’s and marketing approval-directed filings.
  • Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities is required.
  • Proficiency in communications with FDA personnel is required. Experience in interactions with other health authorities is a plus.
  • Must have strong knowledge of oncology drug development.
  • Experience or knowledge of orphan or genetic rare disease drug development is preferred.
  • Experience in translational medicine, clinical pharmacology, and early stage development is preferred.
  • Requires outstanding knowledge of the competitive atmosphere for drugs in the hematology/oncology marketplace and in research and development pipelines.
  • Must have a thorough knowledge of clinical research concepts, practices, and GCP and ICH guidelines.
  • Must possess excellent communication skills and be capable of articulating the company’s clinical and regulatory strategies and progress to a wide audience including the CEO, the Board of Directors, company employees, and the investor community.
  • Must have excellent leadership and interpersonal skills.
  • Proven skills as an effective team player who can engender credibility and confidence within and outside the company with an outstanding executive presence are preferred.
  • Must be science and data driven.
  • Requires the ability and strong desire to “make things happen”.
  • Must have a results-oriented work ethic and a positive, can-do attitude.
  • Effective leadership, people management, communication skills and a team builder management style are required.
  • Requires willingness and ability to be “hands on”.
  • Must have the highest personal values and ethical standards.
 
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.
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