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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