Research Medical Director (Part TIme) - Maitland, FL

Join a workplace recognized by Newsweek as America's Greatest Workplaces for 2024. Advanced Dermatology and Cosmetic Surgery’s mission is to deliver the highest quality patient care and experience in dermatology and aesthetic services.


The Medical Director of Clinical Research is responsible for providing clinical and medical expertise across all phases of clinical trials. Working in close partnership with the Clinical Research Administrator, this role ensures patient safety, protocol integrity, data quality, and compliance with regulatory and ethical standards. The role serves as a key liaison between the investigators and cross-functional teams to support the successful execution of clinical trials.


KEY RESPONSIBILITIES

Medical Oversight & Patient Safety

Serve as the primary medical contact for clinical trial sites and safety queries.

Conduct ongoing medical review of clinical trial data, including adverse events (AEs), serious adverse events (SAEs), and protocol deviations.

Ensure timely medical assessment and reporting of safety data to internal and external stakeholders.

Alongside the Clinical Research Administrator, ensure trials are conducted in accordance withICH-GCP, local regulations, and internal SOPs.

Support preparation and review of clinical and safety sections of regulatory documents (e.g., INDs, CTAs, CSRs).

Maintain awareness of current dermatologic clinical practice and evolving regulatory expectations related to dermatology studies.

Protocol Development & Scientific Leadership

Provide medical insight during protocol feasibility and site selection processes.

Review medical components of clinical study documents, including the Investigator Brochure (IB), Clinical Study Report (CSR), and Informed Consent Forms (ICFs).

Provide guidance on the use of clinical photography, lesion tracking, histopathology requirements, and biomarker collection (e.g., skin biopsies).

Review subject enrollment eligibility and diagnostic accuracy of dermatologic conditions.

Cross-functional Collaboration

Work closely with clinical operations, data management, and compliance teams

Participate in clinical trial team meetings and provide medical expertise throughout the trial lifecycle.


Support training of clinical site staff and internal teams on the medical and scientific aspects of the study.

Regulatory & Ethical Compliance

Ensure studies are conducted in accordance with ICH GCP, local regulations, and company SOPs.

Support regulatory filings, including IND/CTA submissions and responses to health authority queries.

Contribute to the development of safety narratives and clinical sections of regulatory documents.


KNOWLEDGE, SKILLS, AND ABILITIES

Knowledge of ADCS policies, including quality assurance policies and applicable government regulations and standards, and the ability to actively apply that knowledge in the performance of all job duties

Knowledge of electronic health record access-level privileges and responsibilities, and the ability to perform electronic health record job duties for this position within the parameters of the access level assigned

Ability to practice confidentiality and follow HIPAA regulations with patient information

Ability to practice professional ethics and use discretion concerning ADCS directives and proprietary information/trade secrets of the organization

Ability to recognize a problem and effectively problem-solve, using guidance from the provider and/or management when necessary

Knowledge of medical terminology and ability to use appropriately

Ability to manage time efficiently, prioritize, multi-task, and adapt to change

Ability to maintain high level of accuracy in all documentation and in the performance of all job duties

Ability to perform the essential job duties within the scope of education and training

Skilled in typing/keyboarding; skilled in using computers


PROFESSIONALISM

Project a professional manner and image, including proper workplace attire and grooming standards; exhibitprofessional conduct at all times


Adhere to ethical principles and core ADCS values; follow all ADCS policies

Treat all patients and staff with respect, compassion, and empathy, recognizing and respecting cultural diversity

Demonstrate initiative and responsibility for actions

Work as an effective team member

Maintain a strong record for attendance and punctuality in arriving at work

Enhance skills through continuing education


Education: MD, DO, or equivalent medical degree; board certification preferred.


Experience:

Minimum 3–5 years of clinical research ex