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Director of Chemical Development Director of Chemical Development
(SENIOR) CLINICAL TRIAL MANAGER

2.104

Unity Biotechnology is seeking a dapper and dedicated Clinical Trial Manager (CTM) or Senior CTM to oversee the full clinical trial lifecycle with skill and panache. Our dream CTM has prior experience conducting feasibility assessments, driving start-up and recruitment, managing database snapshots, as well as preparing a study for closeout. Our CTM will develop accurate trial budgets and timelines and to execute the trial within endorsed budget and timeline.

Our enthusiastic candidate understands key deliverables toward which to effectively lead a cross-functional team, and takes a proactive, risk-based approach in collaborating with CRO(s) and vendors for successful and timely delivery of quality trial data.

A remote arrangement is possible; we ask non-locals to spend one week every month or two at our South San Francisco office. Local applicants can expect a hybrid arrangement, spending two days per week in the office (with compassionate allowances that can count excessive travel as office time).

Specific Responsibilities:

  • Drives and manages the planning, set-up, and day-to-day operations of assigned study(ies) to enable on-time and on-budget execution of clinical trials, while ensuring the trial is conducted in compliance with the protocol, SOPs/Work Instructions, ICH-GCP, and applicable regulatory requirements
  • Drives protocol and informed consent preparation/finalization
  • Leads the development of study plans and presentations, as well as ensures study team and site training needs are met and documented
  • If you occasionally launch into a rollicking Broadway showtune, that’s okay too
  • Collaborates with key stakeholders to develop site lists and creates criteria for site selection
  • Oversees site contract and budget negotiations to ensure timely resolution
  • Ensures responses to regulatory and review board inquiries are adequately addressed in a timely manner
  • Supports the development of study documents and tools such as CRFs and CRF guidelines, as well as clinical data review
  • Collates, maintains, and reports on study metrics through clinical study dashboards and trackers; archives reports
  • Develops risk management and mitigation plans to ensure overall study objectives are successfully and compliantly accomplished
  • Distributes and archives study newsletters, tracking and reporting of recruitment updates
  • Manages investigational product (IP) supply/resupply, accountability and reconciliation process
  • Develops and reviews key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determines appropriate action in conjunction with study team
  • Reviews site, CRO and other third-party study vendor invoices to ensure that work is performed in accordance with scope of work
  • Partners with CRO(s) and vendors to develop predictive timelines and budgets to drive execution per endorsed timeline and budget
  • Develops and monitors Key Performance Indicators for CRO(s)/key vendors, and support course-correction when appropriate
  • Reviews monitoring trip reports and conducts risk assessment of action items to ensure timely resolution
  • Participates in site visits as needed or accompany CRO members for training and oversight purposes
  • Mentors junior members of the Clinical Operations team
  • Motivates and engages study team members to build high performing team(s)
  • Maintains awareness of competitive landscape, changing regulations and guidance with ability to assess the impact on clinical projects and make modifications as necessary
  • Creatively approaches challenges and problem resolution to optimize the conduct of clinical trials
  • Foresees and presents multiple opportunities/possibilities, but has the confidence to single out a preferred option

REQUIREMENTS:

Education and Qualifications:

  • Bachelor's Degree or relevant clinical development experience
  • Minimum 1 years (CTM), 3 years (Sr CTM) of clinical research experience with increasing responsibilities
  • Cross-functional team leadership experience
  • Demonstrated experience in core and technical aspects of supporting phase 1-3 clinical trials
  • Experience managing vendors, including performance assessments and total financial management (invoice review, change order management, budget reforecasting)
  • Demonstrated willingness to be hands-on and perform tasks within a dynamic and fast-paced environment
  • Ophthalmology experienced is preferred
  • Excellent interpersonal and communication skills
  • Are you a baker? We love cookies. Just sayin’
  • In depth knowledge of PC operating systems; Microsoft Office, including MS Word, MS Excel, MS PowerPoint, MS Project, MS Publisher, MS Outlook, and MS Windows NT
  • Exposure to CTM systems, EDC systems – eClinical, Medidata RAVE, InForm and Safety/ Pharmacovigilance databases (ARGUS) – a plus
  • Proactive, self-directed, able to thrive and adapt and solve problems in a rapidly changing environment
  • Successful management of clinical studies within timeline and budget
  • Embraces the ideas of others, nurtures innovation and manages goals to reality
  • Demonstrated ability to work independently as well as part of a multi-functional study team
  • Able to assimilate information quickly, grasping critical factors and risks, while implementing immediate change where/when needed
  • Strives to create a dynamic environment, opens to suggestions and experimentation for improvement
  • Able to motivate a team to work effectively under a changing environment
  • Appreciates an engaged, fun, and rapidly paced environment, and can get behind the company’s mission to solve the problems of aging
  • Able to set a high level of accountability and quality in deliverables
  • Able to build strong relationships with peers and partners both within and across functional teams to engage high performance
  • Up to 15% travel is required based upon business needs

Please send resume and cover letter