出海雷达

执行医疗主任,(视网膜项目)

Executive Medical Director, (Retina Program)

其他限定地区(需当地身份)
公司4DMT
薪资$350,000 - $398,000/年
工作地点United States
地域资格限定地区(需当地身份)
时区要求日间重叠约 9 小时,基本正常作息
用工类型Full Time
发布时间14 天前
数据来源Himalayas
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注意地域限制:该职位明确限定在 United States 招聘。如果你是位于中国大陆的求职者,通常需要当地工作身份才能投递,或需与雇主确认是否接受独立合同(Contractor)形式合作。

注意招聘机构:所有机构咨询均通过4DMT内部人才招聘团队审核。不接受未经请求的简历。4DMT人才招聘团队必须明确参与任何职位需求的机构合作。直接联系招聘经理的机构将不被容忍,此举可能影响您未来与4DMT的合作。

4DMT是一家领先的后期阶段生物技术公司,正在推进具有潜在变革治疗范式的持久性、疾病靶向疗法,为患者带来前所未有的益处。公司的主要产品候选药物4D-150旨在成为治疗致盲性视网膜血管疾病的基石疗法,通过一次安全的玻璃体内注射,提供多年持续释放抗VEGF(aflibercept和抗VEGF-C),显著减少目前单次注射治疗带来的负担。4D-150的主要适应症是湿性年龄相关性黄斑变性,目前处于III期开发阶段,第二个适应症是糖尿病性黄斑水肿。公司的第二款产品候选药物4D-710是首个已证明在囊性纤维化患者肺部通过雾化给药成功递送并表达CFTR转基因的基因疗法

总体概述
执行医学总监将向首席医学官汇报,同时与研究与早期产品开发副总裁有虚线关系,负责眼科治疗领域的临床试验设计、执行和分析

主要职责与任务:

  • 临床开发领导
  • 担任I期视网膜临床试验的临床负责人,包括研究设计、方案开发、剂量递增策略和安全性监督
  • 对研究执行、数据解读和临床结果负责,包括早期信号检测和继续/终止建议
  • 担任指定研究的医学监查员,确保受试者安全和数据完整性
  • 领导跨职能研究团队(临床运营、临床科学、统计、监管、安全、CMC等),确保高质量和及时的试验交付
  • 为来自临床运营、临床科学、统计、监管事务、CMC、药理/毒理、药物安全、商业和联盟伙伴的多学科研究执行团队提供临床领导力
查看英文原文

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. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.

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 Executive Medical Director will report to the CMO, with a dotted-line relationship to the SVP of Research & Early-Stage Product Development, and will be responsible for the design, execution, and analysis of clinical trials in the ophthalmology therapeutic area
MAJOR DUTIES & RESPONSIBILITIES:

  • Clinical Development Leadership
  • Serve as the clinical lead for Phase 1 retina clinical trials, including study design, protocol development, dose escalation strategy, and safety oversight
  • Maintain accountability for study execution, data interpretation, and clinical readouts, including early signal detection and go/no-go recommendations
  • Serve as medical monitor for assigned studies, ensuring subject safety and data integrity
  • Lead cross-functional study teams (clinical operations, clinical science, biometrics, regulatory, safety, CMC, etc.) to ensure high-quality and timely trial delivery
  • Provides clinical leadership to multidisciplinary study execution teams drawn from clinical operations, clinical science, biometrics, regulatory affairs, CMC, pharm/tox, drug safety, commercial, and alliance partners
  • Has lead accountability on the study teams for delivery of study protocols, study conduct, and study readouts
  • Biomarker & Translational Strategy
  • Lead development and implementation of biomarker strategies for GA and broader retina programs
  • Collaborate with research and translational teams to identify, validate, and integrate imaging, molecular, and functional biomarkers into early-phase trials
  • Ensure biomarkers are aligned with mechanism of action, dose selection, and clinical endpoints to support decision-making and regulatory strategy
  • Regulatory & Clinical Documentation
  • Serve as the primary clinical author of development plans, protocols, IBs, INDs, CSRs, and regulatory responses
  • Lead clinical contributions to IND submissions and early regulatory interactions, including Health Authority meetings for Phase 1 programs
  • Ensure accuracy, scientific rigor, and regulatory compliance of all clinical documents
  • External Scientific Leadership
  • Organizes and leads scientific advisory board meetings. Interacts with external experts and stakeholders to gather input.
  • Works with the research organization and the portfolio management team to identify and support new project opportunities.
  • Collaborates to identify program risks, and to create and implement mitigation strategies
  • Other duties as assigned

QUALIFICATIONS:
Education:

  • Medical Degree (M.D.), other degrees considered with relevant experience
  • Residency training in Ophthalmology with a preference for subspecialty training in retina
  • Board certification/retina fellowship training are a plus

Experience:

  • 10+ years of clinical ophthalmology research in the biopharmaceutical industry
  • Experience with medical monitoring and oversight of Phase 1 retina clinical trials
  • Experience with gene therapy clinical studies
  • Experience in other phases (Phase 2, 3) of clinical research.
  • Experience with NDA/BLA/MAA submission planning and execution
  • Experience in data analysis, data interpretation, and medical writing

Other Qualifications/Skills:

  • Knowledge of ICH-GCP and FDA regulatory guidelines.
  • Knowledge of international regulatory guidelines
  • Effective written and verbal communication skills, including public speaking

Travel: up to 20%
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: $350,000 - 398,000
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

Originally posted on Himalayas

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