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Associate Medical Director/Medical Director - Cardiology

Thermo Fisher Scientific
Thermo Fisher Scientific
1-2+ years
preferred by company
10 Dec. 24, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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

Job ID: R-01332736
Employment Type: Full-Time
Category: Clinical Research / Pharmacovigilance
Work Mode: Fully Remote
Eligible Locations: United States & Canada

About the Organization

Thermo Fisher Scientific is a global leader in serving science, enabling customers to make the world healthier, cleaner, and safer. Through its PPD® Clinical Research portfolio, the organization delivers comprehensive clinical development, laboratory, and pharmacovigilance services across the entire drug development lifecycle. With a strong global footprint, Thermo Fisher Scientific supports innovative research programs that address some of the world’s most complex medical challenges.

Role Overview

The Associate Medical Director / Medical Director – Cardiology provides strategic and operational medical oversight across clinical trials and post-marketing safety activities. This role plays a critical part in ensuring patient safety, regulatory compliance, and scientific integrity across global clinical research programs, with a focus on cardiovascular therapeutics.

The position is remote-based (U.S./Canada) and offers end-to-end exposure across all phases of drug development, including clinical trials, safety surveillance, regulatory submissions, and medical monitoring.

Candidates must be legally authorized to work in the United States without sponsorship.

Key Responsibilities

Medical & Safety Oversight

  • Provide medical leadership and oversight for clinical trials in accordance with GCP, ICH, FDA, EMA, and internal SOPs

  • Perform medical review and analysis of serious adverse events (SAEs), ICSRs, and adverse events of special interest

  • Support preparation and review of periodic safety reports including PSUR, DSUR, PBRER, and signal detection reports

  • Monitor safety variables including laboratory abnormalities, concomitant medications, unblinding requests, and clinical outcomes

Clinical Trial & Project Support

  • Serve as a medical consultant to investigators, sponsors, and cross-functional project teams

  • Participate in investigator meetings, sponsor meetings, and internal project discussions

  • Provide protocol interpretation, therapeutic training, and medical guidance throughout study conduct

  • Review clinical study reports (CSR), IND/NDA documentation, CTD modules, RMPs, REMS, and labeling documentation

Marketed Product Support

  • Conduct aggregate safety data reviews and signal detection activities

  • Support risk management planning, label updates, and post-marketing safety surveillance

  • Medically assess adverse events from all data sources including spontaneous, solicited, and literature reports

Qualifications & Experience

Education

  • MD or equivalent medical degree required

  • Active medical licensure preferred but not mandatory

Experience Requirements

Associate Medical Director Level:

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

  • Minimum 2 years of clinical cardiology patient care experience

  • Exposure to clinical research, pharmacovigilance, or medical monitoring preferred

Medical Director Level:

  • MD with formal Cardiology training and 2+ years of clinical experience

  • 1–2 years of industry experience in a CRO, pharmaceutical, or biotech organization or

  • 2+ years of direct pharmacovigilance/drug safety experience

  • Experience in clinical development and medical monitoring strongly preferred

Job leveling (Associate vs Medical Director) will be determined based on education, experience, therapeutic expertise, and interview evaluation.

Core Skills & Competencies

  • Strong therapeutic expertise in cardiology and related sub-specialties

  • Excellent clinical judgment, analytical, and decision-making skills

  • Proven ability to collaborate across multidisciplinary global teams

  • Strong written and verbal communication skills in English

  • Working knowledge of safety databases (e.g., MedDRA)

  • Understanding of regulatory frameworks (FDA, EMA, ICH, GCP)

  • Ability to manage multiple priorities in a fast-paced environment

  • Willingness to travel domestically and internationally as required

Work Environment

  • Remote office-based role with occasional domestic and international travel

  • Prolonged computer-based work with high attention to detail

  • Independent work requiring sustained concentration and accountability

Benefits & Career Growth

Thermo Fisher Scientific offers a competitive compensation package, annual incentive bonuses, comprehensive healthcare benefits, and long-term career development opportunities. Employees benefit from a culture of scientific excellence, integrity, innovation, and global collaboration.


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