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EPM Scientific - Phaidon International

Clinical Program Lead

EPM Scientific - Phaidon International, San Francisco, California, United States, 94199


Title:

Clinical Program LeadSalary : $160K-175KCompany Summary:

A global, specialty pharmaceutical group with an impressive track record is seeking a motivated Clinical Study Lead for a hybrid role in San Francisco (Palo Alto). Their commercial supply of pharmaceutical products generated $83m in revenue in FY2023 (a 24% uptick from the year prior during a year of record layoffs). Since their first clinical trials in 2006, they've had 3 approvals already on the market. Currently, they have 6 indications in Phases II and III, so they are looking for a driven, growth-oriented Clinical Program Lead with EU trial experience to drive their pipeline forward.***** Candidate must be based in SF to be considered.*****The Clinical Program Lead will be responsible for:Leading the design, monitoring, data interpretation and reporting activities related to the conduct of clinical studies, in accordance with applicable regulations, ICH/GCP regulations and Standard Operating Procedures (SOPs) within assigned program(s)Implementing processes and initiatives to support the clinical program and study delivery driving overall portfolio deliverySupporting the Director, Global Clinical Affairs (Clinical Operations, this is NOT a medical device position)Oversight and execution of:Scientific components of the program (e.g. scientific literature review)Protocol development, implementation of Quality by Design principlesStudy Monitoring, oversight of data quality, patient safetyData management/cleaning activitiesClinical sites (e.g. support clinical study leads / project associates in mgmt and oversight)Direct reports within the Clin Ops teamAn ideal candidate for this role MUST have…Experience establishing and/or managing a clinical trial program in EU5+ years of sponsor experience -

REQUIRED2+ years of experience managing studies or trials EU -

REQUIRED2+ of experience managing direct reportsA Bachelor's degree in Biological Sciences, Nursing, Pharmacy or a related disciplineA working knowledge of ICH GCP guidelinesBenefits:Competitive salary with benefitsHigh degree of commercial exposure early in your careerBeing a part of team whose work directly aims to improve the quality of people's livesGreat work-life balanceIf you are interested in this Clinical Program Lead role, please apply.

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