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Director, Clinical Operations

Company: Rhythm Pharmaceuticals, Inc
Location: Boston
Posted on: January 27, 2023

Job Description:

Company OverviewRhythm is a global, commercial-stage biopharmaceutical company committed to transforming the care of people living with rare genetic diseases of obesity. Working at Rhythm means that you are part of a team that's passionate about transforming the lives of people living with rare genetic disorders of obesity. 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.Job SummaryRhythm seeks an experienced and highly motivated individual 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 play a meaningful role in overall success of our clinical development programs and will be responsible for overseeing study execution with external clinical research organizations, and collaborating with internal cross functional colleagues. As such the Director of Clinical Operations will routinely interact with the program management, clinical development, medical, translational research, regulatory, chemical manufacturing, biostatistics and data management groups to ensure deliverables are met. The Director, Clinical Operations will have experience and in-depth knowledge of global regulatory, ethics and human subject research, clinical trial operations, and pharmaceutical industry rules and guidelines to drive the clinical development programs through all phases of development. The successful candidate will provide proactive mentorship and guidance to junior members of the Clinical Operations team and may have management and oversight responsibilities for our Clinical Trial Associates and/or Clinical Project Managers.Responsibilities and Duties

  • Oversee and lead integrations of all clinical study activities leveraging internal and external vendor resources, expertise and knowledge
  • Provide trial cost estimates and timelines as part of CDP development
  • Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies.
  • Communicate and interact with Key Opinion Leaders and key members of executive leadership team
  • Oversee or manage all aspects of CRO/vendor engagements, including identification, request for proposal submission, CRO selection, and the day-to-day operational management activities of CRO.
  • Oversight of study quality and GCP compliance
  • Oversee and/or manage and provide mentorship for junior clinical operations team members
  • Lead or oversee the development of contingency/risk management plans and associated mitigation strategies
  • Oversee and coordinates with document specialists regarding study files and Trial Master File (TMF) quality checks, including oversight of junior team members
  • Prepare or review budgets, timelines, and forecasts for assigned clinical studies
  • Interface and align with cross functional teams including 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
  • Actively contribute to, oversee or lead the development of processes, tools, and standards necessary to establish best-in-class clinical operations, facilitate lessons learned and best practice sharing, identify process inefficiencies and/or compliance gaps, and drive continuous process improvement initiatives across functional areas of Rhythm. Qualifications and Skills
    • BA/BS degree, advanced degree preferred
    • 10+ years of relevant experience within a CRO, pharmaceutical, and/or biotech company
    • Experience working on Phase I - IV multinational clinical studies
    • Proven excellence in clinical operations execution, including simultaneous oversight of multiple clinical trials, reports and submissions.
    • Regulatory knowledge, including Good Clinical Practices (GCPs)
    • Strong understanding of the drug development process and working knowledge of the essential activities for all key functional areas within clinical operations and across cross-functional teams.
    • 3+ years' experience managing clinical operations teams.
    • Exceptional planning and organizational skills and ability to execute while dealing with competing priorities
    • Strong risk identification, reasoning and problem-solving ability
    • Demonstrated effective leadership and project management
    • Passion and excitement for driving research forward toward a goal of helping patients with rare, unmet medical needs.
    • Ability navigate ambiguity, innovate in dynamic environments, and think creatively to drive positive outcomes, process improvements and quality deliverables.
    • Excellent communication and interpersonal skills (written and verbal)
    • Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project
    • Able to travel (annual average of 10 - 20%)Rhythm values the face-to-face interactions we have while in the office and currently operates in a hybrid work model for Boston-based roles. More about RhythmRhythm is a global, commercial-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity. The company is targeting the melanocortin-4 receptor (MC4R) pathway that is impaired due to genetic variants. 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 disorders 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 genetic disorders of obesity, all driven by genetic variants in the MC4R pathway. For healthcare professionals, visitwww.RareObesity.comfor more information. For those who may be affected or would like to learn more, visitwww.LEADforRareObesity.comfor more information.

Keywords: Rhythm Pharmaceuticals, Inc, Boston , Director, Clinical Operations, Executive , Boston, Massachusetts

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