Role Description
The Board Certified Medical Director - Dermatology will be responsible for the following:
-
Provides medical oversight of assigned clinical studies in the duty as a Medical Monitor.
-
Provides therapeutic input and consultation to customers for assigned clinical studies.
-
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, including review of Informed Consent Templates and subject-facing materials and input into site feasibility evaluations.
-
Responsible for protocol design and development, upon request, and provides input into protocol amendments.
-
Provides medical input into data collection tools, monitoring plans, and review and analysis plans.
-
Provides oversight to assigned Medical Scientist staff and Medical Director colleagues reviewing clinical data; presents identified trends and issues, along with mitigation strategies, to customers and project teams to minimize risks to subject safety or study-data integrity.
-
Provides after-hours medical coverage for clinical studies.
-
Provides input to clinical development or regulatory teams within the Company, upon request.
-
May collaborate with internal stakeholders and customers as part of the pre-sales process.
-
May represent the Company at scientific meetings, upon request.
-
Adheres to enterprise policies, work instructions, standard operating procedures and project plans, as well as applicable customer policies and procedures.
-
Maintains in-depth knowledge of FDA and worldwide drug-development regulations and national and ICH Good Clinical Practice (GCP) guidelines.
Qualifications
-
Board Certified in Dermatology.
-
Experience in clinical studies and medical oversight.
-
Strong understanding of FDA regulations and GCP guidelines.
Requirements
-
Ability to provide medical and therapeutic input to clinical studies.
-
Experience in protocol design and development.
-
Strong communication and training skills.
-
Ability to work collaboratively with internal and external stakeholders.
Benefits
-
Company car or car allowance.
-
Health benefits including 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.
Company Description
Syneos Healthยฎ is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
-
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs.
-
95% of EMA Authorized Products.
-
Over 200 Studies across 73,000 Sites and 675,000+ Trial patients.