Senior Medical Director – MD

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee medical direction for the execution of clinical trials

• Assist in the development activities for proposed and ongoing projects within your area of expertise

• Conduct medical monitoring for designated clinical studies

• Collaborate with GCO to build and strengthen client relationships

• Offer medical/scientific expertise to clients, proposal teams, and internal departments

• Propel projects from a company-wide perspective beyond just the medical aspect

• Provide strategic and tactical subject matter insights for proposals, bid defenses, business development, quality/process enhancements, and audits

• Contribute to the formulation of company policies related to medical, safety, and therapeutics

• Deliver cross-functional scientific and technical support to client medical teams, project teams, investigators, sites, regulatory bodies, ethics committees, safety monitoring boards, and healthcare professionals

• Conduct site/investigator feasibility assessments and foster investigator relationships to aid in trial recruitment and execution

• Engage in client and internal meetings across different time zones

• Assist in recruitment for department roles

• Lead and showcase medical/scientific capabilities within proposal teams

• Manage, supervise, and delegate tasks among up to 5–10 direct and indirect reports as necessary

• Act as Global, Regional, or Program Lead Project Physician across various indications as assigned

• Contribute to the development of medical strategy and the execution of studies/programs

• Review and refine protocols, case report forms, training materials, project tools, analysis plans, clinical trial reports, data tables, listings, figures, and new drug applications

• Prepare materials for and take part in investigator meetings and assist during site initiation visits

• Engage in project risk assessment activities

• Provide out-of-hours medical support as required

• Conduct medical data reviews and supervise central medical data reviewers as applicable

• Review and respond to safety alerts

• Support the medical review of coding

• Assist with data safety monitoring board operations

• Provide clinical and medical expertise to other departments within the company

• Review or assist with the medical monitoring scope of work, hours, and budget discussions

• Oversee medical monitoring activities, timelines, quality of deliverables, and physician resource assignments

• Maintain subject matter expertise through Continuing Medical Education (CME), clinical practice, and relevant conferences/meetings

• Develop training modules and offer disease-area and protocol-specific training

• Participate in company-wide process improvement initiatives

• Represent the company at conferences and scientific meetings

• Lead initiatives within the therapeutic area for physicians

• Carry out other responsibilities as assigned

⛳️ Requirements

• MD degree is mandatory

• MD/DO professional degree/designation/certification/license is legally required

• Relevant subspecialty fellowship training and history of board certification, as necessary

• Acknowledged as a clinical research leader with significant knowledge of drug development and extensive clinical research experience in a specific therapeutic area

• Relevant and equivalent experience may be accepted in lieu of educational qualifications

• 3–10 years of experience with a strong understanding of drug development and extensive clinical research experience within the pharmaceutical/CRO industry in a specific therapeutic area

• Typically 2–5 years of clinical trials medical monitoring experience or other relevant clinical development/trial experience at a CRO, pharmaceutical company, regulatory agency, or clinical practice

• Legally authorized to work in the United States without current or future employer-sponsored work authorization

• Proficient in accessing and utilizing various computer software

• Consistent and regular attendance is required

• Varied hours may be necessary

• Ability to provide 24/7 emergency medical cover during the designated rotation

• Occasional domestic and international travel may be necessary

🏝️ Benefits

• Medical insurance

• Dental insurance

• Vision insurance

• Life insurance

• Short-term disability (STD)

• Long-term disability (LTD)

• 401(k)

• Paid Time Off (PTO) or Flexible Time Off (FTO)

• Company bonus programs where applicable

• Continuing medical education (CME)

• Occasional domestic and international travel