Senior Director, Clinical Development

Jobtailor; Cary (NC); On-site; USD 120,000 - 190,000; Full time

Benefits offered by this job

Adobe Pro

Job summary

Jobtailor in Cary, NC is seeking a Senior Clinical Scientist to drive development plans and oversee protocol creation across trials.

You will serve as sponsor contact for study sites, contribute to medical writing, and coordinate interactions with key opinion leaders while ensuring regulatory compliance and timelines.

Requirements include 7–10 years of clinical research, MD/DO/PhD/PharmD or equivalent, strong writing skills, and willingness to travel up to 25%.

Qualifications

• MD/DO/PhD/PharmD or equivalent degree.
• 7–10 years of clinical research and clinical development experience.
• Ability to interpret, discuss, and present efficacy and safety data.
• Knowledge of FDA/EMEA/PMDA and ICH GCP guidelines.
• Strong project management and medical writing skills.
• Willingness to travel domestically and internationally (approx. 25%).

Responsibilities

• Prepare clinical development plans aligned with project objectives.
• Oversee protocol development from concept to final protocol.
• Serve as sponsor contact for key study sites on protocol topics.
• Write, edit, and review medical and scientific documents.
• Manage interactions with Key Opinion Leaders and Medical Advisory Board.
• Assist Clinical Operations with CRO oversight and performance reviews.

Skills

Clinical development

Medical writing

Regulatory knowledge

Project management

MS Office

Travel flexibility

Education

MD/DO/PhD/PharmD or equivalent degree

Tools

Adobe Pro

Job description

Responsibilities

• Prepare clinical development plans according to the nature of the clinical project and its objectives
• Oversee protocol development from concept to final protocol
• Serve as sponsor contact for key study sites on protocol related topics
• Write, edit, and review medical and scientific elements of both internal and external facing documents inclusive of clinical research
• Manage Key Opinion Leader and Medical Advisory Board interactions
• Assist Clinical Operations with supervision of activities of contract research organizations by reviewing key study plans and performance/quality

Requirements

• MD, DO, PhD, PharmD or equivalent degree or experience
• At least 7-10 years of demonstrated clinical research and clinical development experience required
• Working knowledge of the assigned disease area with proven ability to interpret, discuss, and present efficacy and safety data relating to clinical trial(s)
• Working knowledge of region-specific regulatory guidelines (e.g., FDA, EMEA, PMDA, etc.) and ICH GCP guidelines
• Strong project management and medical writing skills
• Proficiency in MS Office Suite (Word, Excel, PowerPoint) and Adobe Pro
• Ability to travel domestically and internationally, as required (approximately 25%)