Senior Clinical Project Manager

Opportunity 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 of Setmelanotide in rare genetic diseases of obesity. 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

• Prepare budgets, timelines, and forecasts for assigned clinical studies
• Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies.
• Provide trial cost estimates and timelines as part of CDP development
• Manage and provide mentorship for junior clinical operations team members
• Oversee and coordinate with document specialists regarding study files and Trial Master File (TMF) quality checks, including oversight of junior team members
• Communicate and interact with Key Opinion Leaders
• Lead the development of contingency/risk management plans and associated mitigation strategies
• Oversight of study quality and GCP compliance
• Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and the day to day operational management activities of CROs
• Lead and manage integrations of all clinical study activities leveraging internal and CRO resources, expertise and knowledge
• Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure
• Interface with Finance, Program Management, Accounting, Supply Operations, Quality Assurance and Medical Affairs to align on deliverables and execute study activities

Qualifications And Skills

• Regulatory knowledge, including Good Clinical Practices (GCPs)
• Ability to assemble a plan and execute on the details
• Knowledge of global clinical trial management in CRO outsourced environment
• Able to travel (annual average of 10 – 20%)
• BA/BS degree, advanced degree preferred
• Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project
• Experience working on Phase I - IV multinational clinical studies
• Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability
• Excellent communication skills (written and verbal)
• 6+ years of relevant experience within a CRO, pharmaceutical, and/or biotech company

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.

More about Rhythm

Rhythm is a global, commercial-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity. This is a key biological pathway that regulates weight and hunger. A central element of Rhythm’s mission is to improve the understanding of these diseases and develop management strategies for patients who have no treatment options available to them. Rhythm was founded in 2008 and is based in Boston, MA. The company’s clinical development program is currently focused on several rare MC4R pathway diseases. For healthcare professionals, visit www.RareObesity.com for more information. For those who may be affected or would like to learn more, visit www.LEADforRareObesity.com for more information.