Role Description
Reporting to the CMO, the Medical Director β Clinical Development will provide medical expertise and strategic leadership to product development programs across the Bracco Molecular Imaging (MI) platform. Responsibilities will include:
-
Providing medical and scientific leadership and input to product development strategies, product profile development, competitive positioning, and pipeline asset lifecycle.
-
Developing and executing Blue Earth sponsored clinical trials across multiple jurisdictions to GCP standards.
-
Engaging with thought leaders and stakeholders.
-
Supporting cross-functional teams as required.
This is a remote position with a preference for candidates based in the Eastern or Central time zones.
Qualifications
Requirements
-
Clinical care and research experience in the therapeutic areas in which BED has products/developmental assets, preferred.
-
Minimum of five (5) years post Medical Degree experience, preferably with training and/or work experience in radiology or nuclear medicine.
-
At least three (3) years within the Pharmaceutical or Biotech Industry working in Clinical Development.
-
Understanding of the clinical trials and FDA approval processes, preferably with experience of FDA interactions.
-
Experience in Real World Evidence / Observational research preferred.
-
Knowledge and understanding of US regulatory rules landscape (pertinent FDA Guidance for Industry).
-
Strong business and product marketing acumen, vision and perspective.
-
Ability to lead teams with or without management authority, empowering others while ensuring the quality of deliverables.
-
Ability to comprehend and combine complex sets of data, spanning multiple projects and products/agents.
-
Ability to handle multiple demands in a fast-paced environment and to interact within the context of multidisciplinary teams.
-
Ability to work independently to manage the activities of the function and to be accountable for these activities.
-
Able to proactively identify issues and problems, describe and assess risk and chances of product development success, and offer solutions and recommendations on product development issues.
-
Able to make decisions under conditions of uncertainty.
-
If required, able to manage, develop and recruit high quality personnel to form, develop and maintain highly effective teams.
-
Ability to travel, domestic and international, estimated at approximately 30%.
-
Qualified candidate must be legally authorized to be employed in the United States.
Benefits
-
Highly competitive salary for high-caliber candidates.
-
Comprehensive benefits package including a complete healthcare plan.
-
401k with matching.
-
Work/life harmony.
-
Generous paid holidays.