DirecciónDuties and Responsibilities :
- Site engagement and trainingA cadence of touchpoints with sites on a regular basis Meeting with sites and presenting at PSVs, SIVsRetraining as needed (e.g., due to amendments)
- Recruitment issuesSite identification / recruitment : Meeting with potential sites, in collaboration with CTL, to discuss the program / assess of their interestPatient recruitment issues (ongoing oversight) : Meeting with sites, in collaboration with CTL, to help understand the hurdles with recruitment at their site and trouble shooting
- Answering questions from sitesHelping 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 / newThis includes referencing and updating the FAQ, as applicableMedical Director should always be copied on the email correspondence for oversight
- Assisting with eligibility assessmentsHelp perform eligibility checks or address urgent eligibility questions prior to randomization
- Assisting with query closureHelping the site understand what is needed to close a medical query if there is a misunderstanding from the site regarding what is neededFeedback should also be provided to the study team if the query text could be improved for clarityHelping 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 (i.
e., the site has taken all reasonable steps to obtain the information, etc.) in collaboration with the CRA, if additional support is needed during escalation processEnsure that all questions have been answered / follow-up assessments have been doneThis may include requesting additional assessments for a complete evaluation / specialist consultation, etc.
- Protocol DeviationsIn collaboration with the CTL, retrain the site, to prevent future deviations / address any misunderstandings by the site
- Retention issuesHelping 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
- Missing assessmentsFor 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 / CTLFor other studies, may require help in working with site to obtain any key missing assessments (eg, images, PK samples, biomarker samples), in collaboration with the CRA / CTL
- Laboratory reference rangeIn collaboration with the CRA, ensure that the laboratory reference ranges are provided for local laboratory data
- Site issuesDiscussion 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
- Attend CSTs, if possible
- 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 and Experience :
- MD PhD, or PharmD; MD strongly preferred
- 8+ years of industry clinical development experience
- Expertise in clinical trials and clinical development
- Strong understanding of the oncology clinical research landscape and implementation and conduct of oncology clinical trials with a special focus on lung and skin oncology trials .
- Demonstrated ability to develop and maintain excellent working relationships with both internal stakeholders and study investigators and site staff
- Demonstrated ability to work well in cross functional and geographically diverse teams
- Ability to communicate and work independently with scientific / technical personnel with excellent oral presentation skills
- Ability to think critically, and demonstrated troubleshooting and problem-solving skills
- Excellent initiative and judgment, and demonstrated ability to positively represent Regeneron in a compliant manner
- 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
Hace 2 horas
