4D Molecular Therapeutics

4D Molecular Therapeutics

Associate Director, Clinical Operations (Retina Program)

Remote, United States · Director

Sponsorship not specified$179k-$196kDetected 7 days ago
GCPBudgetingRecruitingClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationCollaborationMentoringAdaptabilityRegulatory Affairs

About the role

  • Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team.
  • No unsolicited resumes will be accepted.
  • The 4DMT Talent Acquisition team must expressly engage agencies on any requisition.

Responsibilities

  • Partner with Director of Clinical Operations to develop and manage clinical programs in compliance with corporate objectives and timelines
  • Provide operational leadership to the direction, planning, execution and interpretation of clinical trials and data collection by effectively developing and monitoring clinical trial/program timelines, budgets, risks and mitigation plans
  • Provides guidance and mentoring to Clinical Trial Managers (CTMs) and junior level team members in study document development, vendor and study management, study implementation, issue resolution, timelines, budgeting and resourcing
  • Partner closely with Quality to ensure that the programs and 4DMT always remain inspection ready
  • Coordinates the development and maintenance of clinical SOPs as pertains to the program and provides review/ input into cross-functional SOPs and other documents
  • Supports development and review of protocols/ amendments, study documents and plans, and operational execution
  • Actively participates in CRO, site and vendor selection in order to ensure that trial responsibilities are appropriately delegated and that partners are aligned with corporate objectives; provides ongoing surveillance of progress and ensures that contingency plans are triggered as and where appropriate
  • Collaborate with Regulatory Affairs and Clinical Sciences on the creation of regulatory submissions and compliance to regulatory requirements (eg, Clincialtrials.gov)
  • Contributes to the development of the Clinical Operations department processes and procedures and will manage clinical resources to ensure effective implementation of trials.

Requirements

  • B.S./B.A. with 9+ years of industry experience in clinical development with a minimum of 3 years managerial experience, or M.A./M.S. with 4+ years of experience.
  • Relevant experience in clinical trial execution across all phases
  • Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.
  • Education:
  • Requires late phase trial experience. Relevant experience in clinical trial execution across all phases
  • Ability to communicate to Clinical Operations and Development Leadership team updates and priorities as well as to advocate for required budget and resources
  • Ability to manage and oversee programs that have corporate-wide impact
  • Ability to develop and manage functional and clinical trial-specific budgets
  • Must be self-motivating
  • prioritize and manage a large volume of work

Nice to have

  • B.S./B.A. in Life Science or related discipline required
  • Advanced degree (M.S./M.A., MPH, MHS, MBA) preferred.
  • Clinical Research certification preferred, but not required.

Skills

  • Proven ability to recruit, retain, organize, and motivate clinical operations personnel
  • Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials
  • Ability to be flexible and adaptable to changing business needs
  • Excellent communication and interpersonal skills
  • Must be able to write clearly and summarize information effectively
  • Must be able to present complex information to various audiences
  • Travel: Anticipate 20%, or as trial needs demand
  • Physical Requirements and
  • Other Qualifications/Skills:

Compensation

  • Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate's geographical location, relevant work experience, skills, and years of experience.
  • $179,000 - $196,000

Equal opportunity

  • Employer/Protected Veterans/Individuals with Disabilities
  • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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This listing is sourced directly from 4D Molecular Therapeutics's careers page and normalized into a canonical job model.