Quality Recruiting. Established Experts.

Medical Director Rheumatology

Reference Number: 2649
Location: IL, MA, or Germany

Our client is a major global biopharmaceutical company.  They have asked us to assist them in their search for a Medical Director for the Rheumatology therapeutic area.

The Medical Director Rheumatology oversees the direction, planning, execution, and interpretation of clinical trials/research and the data collection activities, and establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. He/She may recruit clinical investigators and negotiate study design. This role is responsible for creating clinical development plans and for directing human clinical trials, Phases I – IV, for company products under development. Responsibilities also include adverse event reporting and safety responsibilities and monitoring. The Medical Director coordinates and develops reporting information for reports submitted to Global Regulatory Authorities including EMEA, FDA and other national authorities, and monitors adherence to protocols and determines study completion. The Medical Director may act as consultant/liaison with other corporations when working under licensing agreements.

Responsibilities include:

  • Accountable for the design and management of clinical development plans based on strong medical and scientific principles, knowledge of the regulatory requirements and company’s customers, markets, business operations and emerging issues. Responsibility may extend from early translational development activities to mature product life cycle management strategies.
  • Manage the design, conduct and reporting of clinical trials in line with the development, regulatory and commercial strategy.
  • Supervise 0-8 employees either directly or in a matrixed environment.
  • Should be able to serve as a global product safety officer, responsible for global product safety.
  • Participation in design and execution of clinical trial safety, product safety and risk management plans. Responsible for routine and adhoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) in the conduction of clinical studies. Oversee the conduct of clinical trials and medically and scientifically accountable for resolution of safety (AE’s & SAE’s) issues, interpretation of statistical analyzes for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.
  • May be responsible for opinion leader development within the therapeutic area.
  • May interact with and coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going clinical projects.
  • May act as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities.
  • Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
  • Represent the company at external meetings including investigator meetings, scientific association meetings, etc.
  • Understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions.
  • May act as medical/scientific leader for projects within an area or across several areas (ie. GSS).
  • With project director, responsible for setting clinical trial strategy and contributing to the program development strategies to carry out overall program objectives.
  • With project director, ensures budgets, timeliness, compliance requirements are factored into programs' scientific activities.

 

We seek candidates with the following qualifications:

 

  • Medical Doctorate (M.D.) Degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements) with relevant therapeutic specialty in an academic or hospital environment. Completion of residency and/or fellowship is preferred.
  • Minimum of 2 years of clinical trial experience in the pharmaceutical industry or academia or equivalent. 3+ years of experience is preferred.
  • Proven leadership skills in a cross-functional global team environment. Ability to interact externally and internally to support global business strategy.
  • Ability to run a clinical study or development team independently with little supervision. Knowledge of clinical trial methodology, regulatory requirements governing global clinical trials and experience in the design and execution of protocols, and global development programs. This knowledge set is typically associated with a minimum of 3 years of clinical development experience in a pharmaceutical company/CRO/Bio Technology company plus expert knowledge in a relevant therapeutic specialty.
  • Must possess excellent oral and written English communication skills. Ex-Us: At least one further major international language is preferred.

 

Do you have the skills and experience we seek and want to join the top-notch clinical development team of a proven global pharmaceutical leader? Please email your resume in Word format to us today.  Include your daytime phone number and we will contact you confidentially or reply to your email.