Medical Director, Nephrology

Employer
Retrophin
Location
San Diego, California
Posted
Aug 22, 2020
Ref
R-100050
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time

At Retrophin, our mission is to identify, develop and deliver life-changing therapies to people living with rare disease. Giving patients a chance, providing hope, is what drives us.

Retrophin recognizes that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of patients. Our work is rewarding, professionally and personally because we are making a difference and we are passionate about what we do.

We are seeking talented individuals with an entrepreneurial drive who will thrive in our collaborative, fast paced environment and share in our mission to help others. We are headquartered in San Diego, CA with additional offices in Dublin, Ireland.

Position Summary:

The Medical Director, Nephrology will provide medical management and medical support for clinical research projects. This position will work with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution and ensure Good Clinical Practices (GCPs) are followed. This individual will develop protocols and case report forms to provide efficacy and safety information for Phases 1 through 3 clinical trials.

Essential Functions:
 

  • Design, implement and monitor clinical studies of compounds designated for clinical development to ensure timely completion of studies.
  • Develop protocols and case report forms, which will provide adequate efficacy and safety information for Phases 1 to 3 of clinical trials.
  • Partner with data management personnel to plan data entry and analysis and recruit, screen and select qualified investigators.
  • Strong ability to organize and present at investigator meetings.
  • Ensures that Good Clinical Practices (GCPs) are followed.
  • Monitor data for safety and efficacy trends by reviewing all clinical data.
  • Responsible for writing clinical reports upon completion or termination of studies in collaboration with statistical staff.
  • Review requests for results of Investigational New Drugs (IND) studies and provide input for pharmacokinetics and pre-clinical studies.
  • Prepare clinical portions of INDs, New Drug Applications (NDAs) and Biological License Applications (BLAs), including protocols, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales and benefit/risk ratios.
  • Direct and plan clinical programs and develop timetables, budgets and resource analysis for clinical programs and personnel administration.
  • Establish and maintain relationships with alliance partners, external companies, investigators and key opinion leaders to optimize performance on clinical trial activities.
  • Prepare manuscripts for scientific and medical journals and prepare and present at scientific meetings.
  • Participate in due diligence activities for potential business development opportunities from a clinical perspective.


Qualifications:

 

 

  • Requires an MD and/or PhD, MD-PhD preferred with strong nephrology training in related Life Sciences discipline. Equivalent combination of education and applicable job experience may be considered.
  • 4-6 years' experience in the medical, pharmaceutical or biotechnology industry with a strong interest and background in science; 2-4 years of progressive leadership roles.
  • Strong professional experience in a similar role within the pharmaceutical industry, preferably small molecule pharmaceuticals.
  • Strong leadership skills with an ability to set vision, lead change, and mentor others.
  • Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving.
  • Demonstrated ability to review, interpret and present complex scientific data.
  • Well organized with the ability to multitask, prioritize and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
  • Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
  • Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
  • Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
  • Ability to travel domestic and internationally.

 


Retrophin, Inc. is an EEO/AA/Veteran/Disability Employer

Retrophin, Inc. is an EEO/AA/Veteran/Disability Employer