Senior Director – Medical Monitor, Immunology/Rheumatology
Location
Florida + 4 moreAll locations: Florida | Illinois | North Carolina | Texas | Washington
Posted
3 days ago
Salary
$146K - $332K / year
Seniority
Senior
Job Description
Senior Director – Medical Monitor, Immunology/Rheumatology
Syneos Health
• Provides medical oversight of assigned clinical studies in the duty as a medical monitor • Often serves as primary medical contact for customers for assigned clinical studies • Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department • Responsible for protocol design and development, upon request • Provides input into protocol amendments • Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed • Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data • Presents identified trends and issues, and mitigation strategies, to customers and project team members to minimize risks to subject safety or integrity of study data • Represents the Company at scientific and industry meetings • Mentors staff to ensure an appropriate level of understanding regarding sound treatment and research principles of specific therapeutic area
Job Requirements
- Provides medical oversight of assigned clinical studies in the duty as a medical monitor
- Often serves as primary medical contact for customers for assigned clinical studies
- Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department
- Responsible for protocol design and development, upon request
- Provides input into protocol amendments
- Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed
- Provides medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification efforts
- Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data
- Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines
- Represents the Company at scientific and industry meetings
Benefits
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- flexible paid time off (PTO) and sick time
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4D Molecular Therapeutics4DMT 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.
Role Description The Medical Director will lead the design, execution, and analysis of clinical trials in the Ophthalmology therapeutic area, with a focus on retina programs. This role provides strategic and operational clinical leadership across cross-functional study teams and serves as a key medical expert internally and externally. Major Duties & Responsibilities - Lead clinical strategy and execution for ophthalmology trials, including protocol development, study oversight, and data interpretation. - Serve as medical monitor for clinical studies, ensuring patient safety and data integrity. - Author and review clinical documents including protocols, IBs, ICFs, INDs, CSRs, and regulatory submissions. - Collaborate with cross-functional teams (clinical operations, regulatory, biometrics, safety, CMC, commercial) to drive program success. - Engage with external experts, organize advisory boards, and contribute to scientific and medical communications. - Identify and mitigate clinical and programmatic risks. - Support portfolio development and evaluation of new clinical opportunities. - Represent the company in regulatory and scientific forums as needed. Qualifications - Medical Degree (M.D.), OD, PhD, PharmD or equivalent - Residency training in Ophthalmology with a preference for subspecialty training in retina - Board certification a plus - Retina fellowship training a plus - 5+ years of clinical ophthalmology research in the biopharmaceutical industry - Experience with Phase 3 retina clinical trials - Experience with gene therapy a plus - Experience in other phases (Phase 1, 2, 4) of clinical research a plus - Experience with NDA/BLA/MAA submission a plus - Experience writing clinical research protocols and acting as a medical monitor - Experience in data analysis, data interpretation, and medical writing - Knowledge of ICH-GCP and FDA regulatory guidelines - Knowledge of international regulatory guidelines a plus - Effective written and verbal communication skills, including public speaking Requirements - Travel: 15% - 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. - Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work). Benefits - Base salary compensation range: $278,000 - 310,000 - 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. Company 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.
• Develops professional relationships and engages with national and regional SLs to ensure access to company-approved medical and scientific information on areas of therapeutic interest and Company products • Conducts peer-to-peer scientific discussions and maintains a reliable presence with those SLs to ensure they have a medical contact within the company • Addresses scientific questions and directs SL inquiries on issues outside of scope (e.g., grants) to appropriate company resources consistent with applicable policies • Maintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI) for your specific therapeutic area • Initiates discussions with SLs and/or potential investigators that include scientific/data exchange within our AOI to determine the alignment with our research strategies, studies concepts, scientific merit, and qualifications for a specific compound or trial • Recommends study sites and identifies potential investigators to participate in phase II-IV clinical development programs, conducts Site Initiation Visits (SIVs), and detects barriers to patient enrollment and retention efforts to achieve study milestones • Engages in scientific congresses and medical meetings, facilitates scientific and data exchange for both Company and competitor data • Gathers feedback, data, or information during routine activities that can help the company better comprehend medical or scientific needs, priorities, or concerns of SLs and/or patients
• Develops professional relationships and engages with national and regional SLs to ensure access to company-approved medical and scientific information on areas of therapeutic interest and Company products • Conducts peer-to-peer scientific discussions and maintains a reliable presence with those SLs to ensure they have a medical contact within the company • Addresses scientific questions and directs SL inquiries on issues outside of scope (e.g., grants) to appropriate company resources consistent with applicable policies • Maintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI) for your specific therapeutic area • Initiates discussions with SLs and/or potential investigators that include scientific/data exchange within our AOI to determine the alignment with our research strategies, studies concepts, scientific merit, and qualifications for a specific compound or trial • Enhances the comprehension of the scientific foundations and goals of investigator-sponsored research • Identifies barriers to patient enrollment and retention efforts to achieve study milestones • Recommends study sites and identifies potential investigators to participate in phase II-IV clinical development programs, conducts Site Initiation Visits (SIVs), and detects barriers to patient enrollment and retention efforts to achieve study milestones • Addresses questions from investigators and provides information regarding participation in Company-sponsored clinical studies
• Engage with national and regional Scientific Leaders to ensure access to company-approved medical and scientific information • Conduct peer-to-peer scientific discussions • Address scientific questions • Initiate discussions with Scientific Leaders and potential investigators for research alignment • Recommend study sites and potential investigators for clinical development programs • Engage in scientific congresses and medical meetings

