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Medical Director of Clinical R&D

Luitpold Pharmaceuticals, Inc.


Location:
Norristown, Pennsylvania
Date:
01/09/2018
2018-01-092018-02-08
Job Code:
1704
Work Type:
Employee
Job Status:
Full Time
Shift:
1st Shift
Specialties:
  • Cardiovascular Disease
Luitpold Pharmaceuticals, Inc.
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Job Details

Luitpold Pharmaceuticals, Inc., a Daiichi Sankyo Group Company, is dedicated to the development and marketing of innovative, quality drugs and medical devices for healthcare professionals, clinics, and hospitals across the United States and Canada. We specialize in sterile injectables, bone regeneration materials for dental procedures, as well as innovative products for veterinary medicine use.

The position of Medical Director within Clinical Research and Development is primarily responsible for the lead medical role for the cardiology program of a branded intravenous iron, including medical guidance for all aspects of the clinical development program.  The Medical Director will serve in a key role for interactions with the FDA, clinical partners, and business partners.

Essential Duties and Responsibilities

Strategic planning for pharmaceutical product development inclusive of

  • Development, plan, and implementation of clinical research programs and trials.
  • Lead role in clinical projects for medical and scientific soundness; provision of medical input to project teams.
  • Development, management, and approval of the scientific methods for design of clinical protocols, case report forms, guidelines, study reports, and manuscripts.
  • Provision of protocol and/or therapeutic area training for the internal and external project teams.
  • Assistance in investigator identification and selection.
  • Assurance of subject safety, adequate reporting, and coding of adverse events in clinical trials.
  • Oversee the generation of Medical Monitoring/Safety Plans.
  • Ensure timely updates to protocols, Investigators Brochures, and product labels as required.
  • Participation in and/or presents at Investigator Meetings.
    • Interactions with Academic Research Organizations, Contract Research Organizations, healthcare consultants, and investigators.
    • Oversee and participate in clinical study report writing, critical medical review, and assessment of written documents.
    • Attend and participate in training lectures, symposia and conferences in order to maintain current license and maintain and promote Company’s therapeutic area(s) of expertise.
    • Key strategic role with cross-matrix teams for integrated clinical programs aligned with regulatory approval pathways. 
    • Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. 

Qualifications and Requirements 

  • Medical degree and board certification in internal medicine and cardiology (preferred); United States medical license preferred.
  • At least 6 years’ experience in pharmaceutical clinical development, academic research, or a clinical research organization (CRO), with focus on cardiology, and evidence of successful ongoing career development.
  • Excellent oral and written English communication skills. 
  • Experience with the US Food and Drug Administration is desired but not required.
  • Ability to make decisions independently and with appropriate input.
  • Ability to work well in a matrix environment, particularly with Project Management, Regulatory Affairs, Pharmacovigilance, and Medical Affairs.   
  • Must have  a valid U.S driver license and be able to operate vehicles safely.
  • Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.

 

We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

 
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