Thepurposeofthispositionistoprovideoversightwithregardstomedicalissuesthatimpactthe full clinical development spectrum for the assigned product.Thejobwillincludeextensiveinvolvementin the design of clinical development plans, clinical trial synopses and protocol development as well as functioning as the medical monitor for the clinical trials (including medical evaluation of adverse events and drug safety). The position will be responsible for overall successful conduct of the clinical trials including oversight of the clinical data quality and achieving the key study milestones in a timely manner. The position will work seamlessly with clinical operations, drug safety, pharmacovigilance, data management/statistics and regulatory as well as other groups within the organization (commercial, business development, etc.) to ensure the appropriate dispersal of information within the company and, as necessary, with external advisors.
This position will also be responsible for proper medical evaluation/interpretation of assigned clinical trials. It requires an understanding of the therapeutic context of the clinical program and is able to discuss hypotheses with experts, investigators and other hospital staff. It will play a key role in the identification of investigators and building/maintaining relationships with opinion leaders.
Oversees all medicalaspectsofstudydesign.
Assists with execution of clinical studies to establish the safety, efficacy and commercial viability of new products.
Actively participates in site selection and assists with providing oversight to assure investigator compliance with the study protocols, regulatory guidelines and company standard operating procedures.
Actively participates in study management with the cross functional clinical team (clinical operations, drug safety, pharmacovigilance, data management/statistics and regulatory, etc.) to ensure the team will achieve key study milestones including timeline and ensure high data quality from the clinical studies assigned.
Assists with study vendors selection and education.
Works with Clinical and Regulatory Affairs in the preparation of project- related documents and regulatory submissions, including Investigator's Brochures, Annual Reports, INDs and NDA's.
Is responsible for medical monitoring portion of site initiation, site oversight and monitoring, on-site presentations, site close-out and especially understanding of adverse events.
Communicates and interacts effectively with in-house personnel, clinical sites and outside contractors/CROs.
Has a teaching role in investigator meetings.
Participates in the formulation of overall clinical strategy.
Functions as Medical reviewer for PV department.
May have clinical interaction with Pacira partners for non-EXPAREL products.
The qualified individual will possess the following:
• MD or DOfromanaccreditedcollegeoruniversity.
• Atleast 5 yearsclinicalresearchexperienceintheU.S.biotech/pharmaceuticalindustry.
Demonstrated workingknowledgeofcGCP,ICH,andotherrelevantclinicaldevelopmentregulationsand processes.
Proven abilitytoworkeffectivelyonateam inanentrepreneurialenvironment.