Associate Director, Clinical Operations

4D Molecular Therapeutics

18h•$180,000 - $200,000

About The Position

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery GENERAL SUMMARY: The Associate Director, Clinical Operations will be responsible for implementation, execution and oversight of all clinical trials within a clinical program, in coordination with cross-functional project teams to ensure that assigned clinical trials are executed on time, within budget, and in compliance with GCP and other applicable guidelines and regulations.

Requirements

B.S./B.A. in Life Science or related discipline required
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.
Require 1+ years ophthalmology trial experience as well as late phase trial experience. Relevant experience in clinical trial execution across all phases
Proven ability to recruit, retain, organize, and motivate clinical operations personnel
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; show attention to detail
Strong interpersonal skills are essential as this individual will partner with various team members and functional groups for clinical trials and business performance
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

Nice To Haves

Advanced degree (M.S./M.A., MPH, MHS, MBA) preferred.
Clinical Research certification preferred, but not required.

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
Independently oversee day-to-day activities of the Clinical Trial Operations and Clinical Data Management groups
Collaborate with Finance/Business Operations on annual budget planning (external spend) as well as quarterly budget reviews and re-forecasts; designing, implementing, and overseeing clinical vendor outsourcing strategy; actively participating in the selection of vendors to support 4DMT clinical trials as well as active governance of them; participating and/or leading vendor governance committees
Ensure that each clinical trial is always inspection ready
Ensure that each clinical trial is being actively managed by a cross-functional Study Execution Team (SET)
May sit on product cross-functional core teams as Clinical Operations SME
Partner closely with Quality to ensure that the programs and 4DMT always remain inspection ready
Collaborate with Regulatory Affairs and Clinical Sciences on the creation of regulatory submissions and compliance to regulatory requirements (eg, Clincialtrials.gov)
Addresses escalated study issues in collaboration with CTMs and senior management as appropriate inclusive of risk mitigation plans
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
Contributes to the development of the Clinical Operations department processes and procedures and will manage clinical resources to ensure effective implementation of trials.