Energy Jobline ZR
Overview
Rhythm is a global, commercial-stage biopharmaceutical company focused on transforming care for people living with rare MC4R pathway diseases. We work to improve outcomes for patients with hyperphagia and severe obesity caused by these rare conditions, and support patients and caregivers on their journey of advocacy. Opportunity Overview
Rhythm seeks experienced, highly motivated individuals to join its team in Boston, Massachusetts. Within the clinical operations group, there are multiple ongoing and planned studies to develop innovative therapies for people with rare neuroendocrine diseases. The position will be responsible for overseeing components of study execution and will routinely interact with the medical, translational research, regulatory, biostats and diagnostic groups to ensure deliverables are met. Responsibilities and Duties
Manage integrations of all clinical study activities leveraging internal and CRO resources, expertise and knowledge Provide trial cost estimates and timelines as part of CDP development Drive execution of clinical trials from protocol design to the final clinical study report for specified studies Effectively communicate with Key Opinion Leaders Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and day-to-day operational management activities of CROs Oversight of study quality and GCP compliance Assist in the development of contingency/risk management plans and mitigation strategies Oversee and coordinate with document specialists regarding study files and Trial Master File (TMF) quality checks, including oversight of junior team members Prepare budgets, timelines, and forecasts for assigned clinical studies Interface with Finance, Program Management, Accounting, Supply Operations, Quality Assurance and Medical Affairs to align on deliverables and execute study activities Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure Qualifications and Skills
BA/BS degree, advanced degree 5+ years of relevant experience within a CRO, pharmaceutical, and/or biotech company Experience working on Phase I - IV multinational clinical studies Regulatory knowledge, including Good Clinical Practices (GCPs) Knowledge of global clinical trial management in CRO outsourced environment Exceptional organizational skills and ability to handle competing priorities, with strong reasoning and problem-solving ability Excellent communication skills (written and verbal) Ability to assemble a plan and execute on the details Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project Able to travel (annual average of 10 – 20%) Work Location & Travel
This role is based in our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates must be willing and able to be in the Boston office in coordination with their department and business needs. Some travel may be required. More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. We are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address root causes. We aim to expand access and develop novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. Our core values are: We are committed to advancing scientific understanding to improve patients’ lives We are inspired to tackle tough challenges and have the courage to ask bold questions We are eager to learn and adapt We believe collaboration and ownership are foundational for our success We value the unique contribution each individual brings to furthering our mission
Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, nationality, genetic information, veteran status, military status, or any other class protected by state or federal law. Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts. Powered by JazzHR Apply via the provided application process. Rhythm Energy Jobline wishes you the very best of luck in your next career move.
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Rhythm is a global, commercial-stage biopharmaceutical company focused on transforming care for people living with rare MC4R pathway diseases. We work to improve outcomes for patients with hyperphagia and severe obesity caused by these rare conditions, and support patients and caregivers on their journey of advocacy. Opportunity Overview
Rhythm seeks experienced, highly motivated individuals to join its team in Boston, Massachusetts. Within the clinical operations group, there are multiple ongoing and planned studies to develop innovative therapies for people with rare neuroendocrine diseases. The position will be responsible for overseeing components of study execution and will routinely interact with the medical, translational research, regulatory, biostats and diagnostic groups to ensure deliverables are met. Responsibilities and Duties
Manage integrations of all clinical study activities leveraging internal and CRO resources, expertise and knowledge Provide trial cost estimates and timelines as part of CDP development Drive execution of clinical trials from protocol design to the final clinical study report for specified studies Effectively communicate with Key Opinion Leaders Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and day-to-day operational management activities of CROs Oversight of study quality and GCP compliance Assist in the development of contingency/risk management plans and mitigation strategies Oversee and coordinate with document specialists regarding study files and Trial Master File (TMF) quality checks, including oversight of junior team members Prepare budgets, timelines, and forecasts for assigned clinical studies Interface with Finance, Program Management, Accounting, Supply Operations, Quality Assurance and Medical Affairs to align on deliverables and execute study activities Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure Qualifications and Skills
BA/BS degree, advanced degree 5+ years of relevant experience within a CRO, pharmaceutical, and/or biotech company Experience working on Phase I - IV multinational clinical studies Regulatory knowledge, including Good Clinical Practices (GCPs) Knowledge of global clinical trial management in CRO outsourced environment Exceptional organizational skills and ability to handle competing priorities, with strong reasoning and problem-solving ability Excellent communication skills (written and verbal) Ability to assemble a plan and execute on the details Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project Able to travel (annual average of 10 – 20%) Work Location & Travel
This role is based in our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates must be willing and able to be in the Boston office in coordination with their department and business needs. Some travel may be required. More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. We are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address root causes. We aim to expand access and develop novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. Our core values are: We are committed to advancing scientific understanding to improve patients’ lives We are inspired to tackle tough challenges and have the courage to ask bold questions We are eager to learn and adapt We believe collaboration and ownership are foundational for our success We value the unique contribution each individual brings to furthering our mission
Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, nationality, genetic information, veteran status, military status, or any other class protected by state or federal law. Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts. Powered by JazzHR Apply via the provided application process. Rhythm Energy Jobline wishes you the very best of luck in your next career move.
#J-18808-Ljbffr