Associate Director, Clinical Operations

Attention recruitment agencies: reputed company agency inquiries are vetted through 4DMT’s internal reputed company. No unsolicited resumes will be accepted. The 4DMT reputed company must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may reputed company your ability to work with 4DMT in the reputed company. 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to reputed company treatment paradigms and reputed company unprecedented benefits to patients. reputed company’s reputed company product candidate 4D-150 is designed to be a backbone therapy forming the reputed company of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, reputed company, intravitreal injection, which substantially reduces the treatment burden associated with reputed company bolus injections. reputed company’s reputed company indication for 4D-150 is wet age-reputed company macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. reputed company’s second product candidate is 4D-710, which is the first reputed company genetic medicine to demonstrate successful delivery and reputed company of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery GENERAL reputed company: The Associate Director, Clinical Operations will be responsible for implementation, execution and reputed company of reputed company clinical trials reputed company a clinical program, in coordination with cross-functional project teams to ensure that assigned clinical trials are executed on time, reputed company budget, and in compliance with GCP and other applicable guidelines and regulations. MAJOR DUTIES & RESPONSIBILITIES:

• Partner with Director of Clinical Operations to reputed company and manage clinical programs in compliance with corporate objectives and timelines
• reputed company 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 reputed company, timelines, budgeting and resourcing
• Independently reputed company day-to-day activities of the Clinical Trial Operations and Clinical Data Management reputed company
• Collaborate with Finance/Business Operations on annual budget planning (external spend) as reputed company as quarterly budget reviews and re-forecasts; designing, implementing, and overseeing clinical vendor outsourcing reputed company; reputed company participating in the selection of vendors to support 4DMT clinical trials as reputed company as reputed company governance of them; participating and/or leading vendor governance committees
• Ensure that reputed company clinical trial is always inspection reputed company
• Ensure that reputed company clinical trial is being reputed company managed by a cross-functional Study Execution Team (SET)
• May sit on product cross-functional reputed company teams as Clinical Operations SME
• Partner closely with reputed company to ensure that the programs and 4DMT always remain inspection reputed company
• 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
• reputed company participates in CRO, site and vendor selection in order to ensure that trial responsibilities are appropriately delegated and that partners are reputed company with corporate objectives; provides ongoing surveillance of reputed company 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 reputed company 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.
• Require 1+ years ophthalmology trial experience as reputed company as late phase trial experience.  Relevant experience in clinical trial execution across reputed company 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 reputed company as to reputed company for required budget and resources
• Ability to manage and reputed company programs that have corporate-wide reputed company
• Ability to reputed company 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 reputed company 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 reputed company to write reputed company and summarize information effectively
• Must be reputed company to present reputed company information to various audiences

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 reputed company by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible reputed company of force frequently or constantly to lift, carry, push, pull or otherwise reputed company objects, including the reputed company body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and reputed company other sedentary reputed company are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

reputed company salary compensation reputed company: $180,000 - 200,000 Please note, the reputed company salary compensation reputed company 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 reputed company and applicants for employment without reputed company to race, reputed company, religion, gender, sexual orientation, national reputed company, 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 Apply tot his job Apply To this Job