Description
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.
Similar jobs
Est. 390,000 USD
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…
Est. 187,500 USD
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…
Est. 337,500 USD
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…
Est. 160,000 USD
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…
Est. 207,000 USD
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…
Est. 262,000 USD
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…
Est. 165,000 USD
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…
Est. 175,000 USD
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…
Est. 135,500 USD
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…
Est. 290,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 285,000 USD
About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Sum…
Est. 200,000 USD
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disea…
Est. 250,000 USD
About Genetix Biotherapeutics At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role,…
Est. 298,500 USD
Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology,…
Est. 355,000 USD
“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) a…
Job Summary: Reporting to the Vice President of Clinical Development and Data Science, the Associate Director, Clinical Development will support research activities leading to the expansion of Revance therapeutic product…
Est. 273,224 USD
Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments…
Est. 277,750 USD
About Beeline Medicines: Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and i…
Est. 234,900 USD
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Est. 298,000 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 317,000 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 298,000 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 396,500 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 371,500 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 249,550 USD
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Est. 317,000 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 371,500 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 200,000 USD
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating…
Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes for all. Our solutions empower life sciences companies to reach diverse populations b…
Est. 270,000 USD
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop diffe…