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Job DescriptionJob Description Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the care of people living with rare melanocortin-4 receptor (MC4R) pathway diseases. Working at Rhythm means that you are part of a team that’s passionate about transforming the lives of people living with hyperphagia (pathological, insatiable hunger) and severe obesity caused by rare MC4R pathway diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Opportunity Overview Rhythm seeks an experienced and highly motivated individuals to join its team in Boston, Massachusetts. Within the clinical operations group, there are multiple ongoing and planned studies designed to develop innovative therapies for people with rare neuroendocrine diseases.
The position will be responsible for overseeing components of study execution and as such 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 the 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 associated 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 deal with competing priorities, also 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%)
This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.
The expected salary range for this position is $110,000 - $165,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.
More about Rhythm We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause.
Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.
At Rhythm 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 , creed, , , , ancestry, , , , , genetic information, veteran status, military status, application for military service, 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.
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If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
We focus on the Oil & Gas, Renewables, Engineering, Power, and Nuclear markets as well as emerging technologies in EV, Battery, and Fusion. We are committed to ensuring that we offer the most exciting career opportunities from around the world for our jobseekers.
Job DescriptionJob Description Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the care of people living with rare melanocortin-4 receptor (MC4R) pathway diseases. Working at Rhythm means that you are part of a team that’s passionate about transforming the lives of people living with hyperphagia (pathological, insatiable hunger) and severe obesity caused by rare MC4R pathway diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Opportunity Overview Rhythm seeks an experienced and highly motivated individuals to join its team in Boston, Massachusetts. Within the clinical operations group, there are multiple ongoing and planned studies designed to develop innovative therapies for people with rare neuroendocrine diseases.
The position will be responsible for overseeing components of study execution and as such 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 the 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 associated 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 deal with competing priorities, also 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%)
This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.
The expected salary range for this position is $110,000 - $165,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.
More about Rhythm We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause.
Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.
At Rhythm 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 , creed, , , , ancestry, , , , , genetic information, veteran status, military status, application for military service, 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
ZXyWPCoe0I
If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.