Associate Director, Clinical Operations

4D Molecular Therapeutics; United States; On-site; USD 179,000 - 205,000; Full time

Job summary

4D Molecular Therapeutics seeks an Associate Director of Clinical Operations to oversee the planning, execution, and oversight of clinical trials within a program. You will work with cross-functional teams to ensure trials run on time, within budget, and comply with GCP and applicable guidelines.

You will lead study timelines, budgets, risk mitigation, and vendor governance, while mentoring CTMs and coordinating with Quality, Regulatory Affairs, and Clinical Sciences.

Qualifications

• 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.
• Ophthalmology/Retina experience required
• Relevant experience in clinical trial execution across all phases

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.

Skills

Ophthalmology/Retina experience

FDA/ICH Guidelines knowledge

Clinical trial budgeting

Leadership/people management

Vendor management

Education

B.S./B.A. in Life Science or related discipline

Advanced degree (M.S./M.A., MPH, MHS, MBA) preferred.

Clinical Research certification preferred, but not required.

Job description

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.

Major Duties & 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.

Qualifications

Education

• 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.

Experience

• 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.
• Ophthalmology/Retina experience required
• Relevant experience in clinical trial execution across all phases

Other Qualifications/Skills

• 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

Travel

Travel: Anticipate 20%, or as trial needs demand

Physical Requirements and Working Conditions

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $179,000 - $205,000

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.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities