Medical Director/Sr Medical Director - Pulmonary

Schedule

Standard (Mon‑Fri) – Office environment.

Responsibilities

• Manage all medical aspects of contracted tasks across the pharmaceutical product life‑cycle.
• Attend and present at investigator and sponsor meetings; provide medical consultation to clients, investigators, and project team members; support business development activities.
• Provide medical review and analysis for clinical trial serious adverse events, marketed product ICSR, and periodic safety reports (e.g., PBRER, PSUR, DSUR) as well as other client deliverables such as labeling reconciliation documents, CTD modules, REMS, RMP, and CSR.
• Ensure tasks delegated to medical monitors are properly executed.
• Adhere to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues.
• Follow client SOPs/directives, project‑specific WPDs, and PPD corporate policies and SOPs/WPDs.
• Provide medical consultation to team members and answer all study‑related medical questions.
• Communicate clearly with associates and clients, maintaining an open line of communication to ensure procedures are followed appropriately.
• Provide therapeutic and protocol training on assigned studies, as requested.
• Assist in writing or reviewing CSR, IND/NDA reports, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc., ensuring medical content accuracy and completeness.
• Monitor all safety variables (adverse events, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un‑blinding requests) of clinical studies.
• Discuss medical concerns with principal investigators and clients, interpreting inclusion/exclusion criteria and applying proper medical judgment.
• Provide medical review of adverse events of special interest, serious adverse events, and clinical outcomes events reported by study sites.
• Perform data review as specified in client contracts and data‑validation manuals, including review of coding listings and full safety data to assess potential safety concerns.

Qualifications

• MD or equivalent required.
• Active medical licensure preferred but not required.
• Clinical experience in Pulmonary/Critical Care with formal training (residency and/or fellowship) and patient‑treatment experience comparable to 2 years.
• For Senior Medical Director level: same clinical background plus either
  • Suitable clinical trial experience in a CRO, pharmaceutical company, or as a principal investigator (1‑2 years), or
  • Direct experience in safety/pharmacovigilance (2 years).
• Preference for individuals with clinical development/medical monitoring experience.
• Equivalency may be considered based on a combination of education, training, and directly related experience.
• Must be legally authorized to work in the United States or Canada without sponsorship.
• Must be able to pass a comprehensive background check, including drug screening where applicable.

Skills

• Therapeutic expertise in Neurology.
• Strong decision‑making, problem‑solving, organizational, and analytical skills.
• Excellent oral and written communication abilities.
• Working knowledge of relevant safety databases (e.g., MedDRA).
• Flexibility to travel domestically and internationally.
• Ability to work independently, analyze work with attention to detail, and prioritize sensitive, complex information.
• Proficiency in basic computer applications; fluent in spoken and written English.
• Excellent interpersonal, influencing, and team‑building skills.
• Understanding of FDA, ICH, EMA, and GCP guidelines.
• Working knowledge of biostatistics, data management, and clinical operations procedures.
• Ability to act as a mentor/trainer to other staff.

Physical Requirements & Work Environment

• Work performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with domestic and international travel.
• Frequently stationary for 6‑8 hours per day.
• Repetitive hand movements; ability to make fast, simple, repeated motions of fingers, hands, and wrists.
• Frequent mobility; occasional crouching, stooping, bending, and twisting of upper body and neck.
• Light to moderate lifting and carrying (up to 15‑20 lb) of objects such as luggage and laptop computers.
• Ability to access and use a variety of computer software (both in‑house and off‑the‑shelf).
• Strong communication skills for conveying information clearly and listening effectively.
• Frequent interaction with diverse groups to obtain or relate information.
• Works independently with minimal guidance; plans work schedules to meet goals.
• Requires multiple periods of intense concentration and ability to perform under stress.
• Ability to multitask and handle variable tasks dictated by changing demands.
• Regular and consistent attendance required.

Benefits

• Competitive remuneration.
• Annual incentive plan bonus.
• Healthcare coverage.
• Range of employee benefits.
• Employment with an innovative, forward‑thinking organization.
• Outstanding career and development prospects.
• Company culture emphasizing integrity, intensity, involvement, and innovation.