English-speaking Area Manager

The Regional Medical Director (RMD) is an integral member of the metabolic/obesity clinical sciences group, who assists and extends Clinical Sciences across the metabolic portfolio on assigned studies at the regional level.

Site engagement and training:

• Retraining as needed.
• Patient recruitment issues (ongoing oversight): Meeting with sites, in collaboration with CTL, to help understand the hurdles with recruitment at their site and troubleshooting.
• Helping address site medical/clinical questions as a first line for those questions that are straightforward or previously addressed or to help coordinate a response with the Medical Director for those that are not straightforward/new. The Medical Director should always be copied on the email correspondence for oversight.
• Help perform eligibility checks or address urgent eligibility questions prior to randomisation.
• Helping site understand what is needed to close a medical query if there is a misunderstanding from the site regarding what is needed.
• Helping ensure that the information that we must have to describe a safety event is sufficient, including ensuring that all information has been gathered as expected.
• Helping to ensure that the site has followed up with patients in the event of lost to follow-up/all appropriate steps have been taken (in collaboration with the CTL) and that any protocol specific requirements have been met.
• For instance, in PNH studies, help to ensure that all LDH values that are not done/unable to be performed are rapidly chased to ensure a repeat is done as quickly as possible, in collaboration with the CRA/CTL.
• For other studies, may require help in working with site to obtain any key missing assessments (e.g., images, PK samples, biomarker samples), in collaboration with the CRA/CTL.
• In collaboration with the CRA, ensure that the laboratory reference ranges are provided for local laboratory data.
• Discussion with the sites for any potential quality issues/concerns requiring physician to physician discussion (first line). The global medical director can be pulled in if the issue cannot be easily resolved.
• Weekly meetings with medical director (if possible) or weekly communication with medical director, at a minimum.
• May provide clinical assistance and feedback on PI interest in proposed studies at the local level.

Qualifications:

• MD, PhD, or PharmD.
• Expertise in clinical trials and clinical development.
• Strong understanding of the Metabolic/Obesity clinical research landscape and implementation and conduct of these clinical trials.
• Ability to communicate and work independently with scientific/technical personnel with excellent oral presentation skills.
• Cross-cultural awareness and fluent in the local language of primary country assignment in addition to English.
• Computer skills including Excel, Word, and PowerPoint.
• A willingness to travel up to 65%, which may include local, regional and international travel.
• Valid driver’s license.