Medical Director, Diabetes
Lexicon (Princeton, New Jersey)
Requisition #-130-252 Medical Director, Diabetes
Lexicon is a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease located in The Woodlands, Texas and Princeton, New Jersey. We currently have multiple programs in clinical development for diabetes, irritable bowel syndrome, carcinoid syndrome and other indications, all of which were discovered by our world class research team. We have used our proprietary gene knockout technology to identify more than 100 promising drug targets. We focus drug discovery efforts on these biologically-validated targets to create our extensive pipeline of clinical and preclinical programs. Lexicon employees are inspired by the idea that their work can improve patients' lives and we know that our employees are important to the success of our mission. We are dedicated to making Lexicon a great place to work by providing employees with the benefits, services, and programs which will allow them to reach their full potential.
We are currently recruiting for a Medical Director for our Diabetes programs in our Woodlands, TX or Princeton NJ office.
This position reports to the Vice President of Diabetes Clinical Development. The Medical Director is responsible for providing the following:
Medical support to the development team which may include but is not limited to evaluating the study for feasibility, providing guidance and advice regarding the various risks associated with a particular study
Ensure the study-related safety of subjects in clinical trials through appropriate medical monitoring of studies on a proactive and ongoing basis
Interface with clinicians/investigative sites for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility
The selected candidate must be available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites
Perform review and clarification of trial-related Adverse Events #AEs#
Perform medical case review of Serious Adverse Events #SAEs# including review of case documentation, and patient narrative
Participate in study design and protocol drafting
Contribute to the generation of the Clinical Development Plan#s# leading to successful registration and launch of NCEs
Collaborate with relevant Lexicon departments in order to follow-up the operational implementation of assigned trials or clinical development programs
Contribute to and review the clinical section of documents including, but not limited to, Protocols, the Investigator Brochure #IB#, Case Report Forms #CRFs#, Annual IND Safety Updates/EU Annual Reports, Clinical Study Reports, patient narratives, and submission related documents such as the Clinical Summary of Efficacy and Safety and the Clinical Overview.
Attend and present at Investigator Meetings
Attend kick-off meetings, team meetings and other meetings as needed or requested
Other responsibilities as determined by manager
The incumbent must be willing to relocate to either Houston TX, or Princeton NJ.
MD from accredited medical school
At least 3 years experience in Clinical Development in a major pharmaceutical company or a clinical research organization; of which at least 1 year is focused in Diabetes/Metabolism or Cardiology
Demonstrated Diabetes therapeutic expertise and experience
Current state medical licensure
Prior or current board certification in a primary care discipline #Prior or current board certification in Diabetes/Endocrinology or other related subspecialty is preferred#
Outstanding verbal and written communication skills, with specific experience in protocol development
Ability and desire to work in a team-oriented environment
Ability to travel up to 30%
To apply, please visit the careers section of our website: https://lexpharmacareers.silkroad.com
For additional information about Lexicon and its programs, please visit www.lexpharma.com.
Lexicon Pharmaceuticals is an equal opportunity/affirmative action employer.