Instagram
youtube
Facebook

Associate Medical Director/Medical Director - Cardiology

1-2 years
Not Disclosed
10 Nov. 26, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Medical Director / Medical Director – Cardiology (Remote, U.S. or Canada)

Job ID: R-01332736
Employment Type: Full-Time
Category: Clinical Research
Work Model: Fully Remote
Locations: Available in 2 approved locations


About the Opportunity

Thermo Fisher Scientific is seeking an experienced Associate Medical Director / Medical Director (Cardiology) to provide medical oversight and scientific leadership across global clinical trials. This position supports the PPD® clinical research services division, a leading global CRO dedicated to advancing innovative therapies through rigorous scientific and clinical expertise.

This role is ideal for cardiology-trained physicians who want to contribute to clinical development, safety oversight, medical monitoring, and regulatory deliverables throughout the full drug development lifecycle.


Work Schedule and Environment

  • Standard Monday–Friday schedule

  • Remote-based (U.S. or Canada)

  • Professional office environment

  • Must be legally authorized to work in the United States or Canada

  • Mandatory background check and drug screening


Position Summary

The Associate/Medical Director provides medical oversight for clinical trials, ensuring adherence to company SOPs, regulatory requirements, and good clinical practice (GCP). Responsibilities include safety review, medical monitoring, interpretation of clinical data, scientific input into regulatory documentation, and support for business development activities. This role interacts closely with sponsors, investigators, and cross-functional teams.


Key Responsibilities

General Medical Oversight

  • Ensure all pharmacovigilance and medical monitoring tasks are executed in compliance with ICH guidelines, regulatory requirements, and client directives.

  • Provide medical consultation to project teams, investigators, and clients.

  • Deliver therapeutic area training and protocol-specific guidance.

  • Review clinical study reports (CSRs), IND/NDA documents, labeling updates, safety deliverables, CTD modules, REMS, RMPs, and other regulatory submissions.

Clinical Trial Medical Monitoring

  • Review safety data including adverse events, laboratory results, medical status changes, concomitant medications, and unblinding requests.

  • Discuss clinical and medical issues with investigators and sponsors, including inclusion/exclusion criteria interpretation.

  • Review adverse events of special interest and serious adverse events.

  • Conduct medical review of coded data, safety listings, and aggregated safety information to identify emerging signals.

Marketed Products and Safety Support

  • Manage signal detection and safety surveillance activities.

  • Review aggregate safety reports such as PBRER, PSUR, and DSUR.

  • Contribute to risk management plans, labeling updates, and safety strategy.

  • Perform medical review of adverse event cases from all sources including spontaneous, solicited, and literature.


Required Education and Experience

Associate Medical Director Level

  • MD or equivalent required.

  • Formal training in Cardiology (residency and/or fellowship).

  • Minimum 2 years of direct patient care experience in Cardiology.

Medical Director Level

  • MD or equivalent required.

  • Clinical experience in Neurology or Cardiology, depending on assignment.

  • Formal specialty training (residency/fellowship).

  • Combination of:

    • 1–2 years of clinical trial experience (CRO, pharma, or principal investigator), or

    • 2 years of pharmacovigilance/safety experience.

  • Industry experience in medical monitoring or clinical development preferred.

Equivalent combinations of education, training, and clinical or industry experience will be considered.


Key Skills and Competencies

  • Strong medical expertise in one or more therapeutic areas.

  • Excellent analytical skills, scientific judgment, and problem-solving ability.

  • Proficiency in reviewing safety data, clinical trial documentation, and regulatory deliverables.

  • Strong understanding of FDA, EMA, ICH, and GCP guidelines.

  • Knowledge of safety databases (e.g., MedDRA).

  • Ability to mentor and guide junior team members.

  • Excellent interpersonal, leadership, and communication skills.

  • Ability to work independently and handle complex, sensitive information.

  • Competence in basic software applications and electronic data systems.

  • Fluent in written and spoken English.


Physical and Work Requirements

  • Ability to work on a computer for extended periods.

  • Occasional domestic or international travel.

  • Capacity to manage multiple tasks with long periods requiring concentration.

  • Regular interaction with global teams and stakeholders.

  • Ability to lift up to 20 lbs and travel with standard work equipment.

  • Consistent attendance and ability to meet deadlines under pressure.


Compensation and Benefits

Thermo Fisher Scientific offers competitive compensation, annual performance incentives, comprehensive health benefits, retirement programs, and extensive professional development opportunities. Employees benefit from an innovation-driven culture built on integrity, involvement, and continuous improvement.