Instagram
youtube
Facebook

Associate Medical Director, Innovative Trial Design, Immunology

2+ years
Not Disclosed
10 Nov. 27, 2024
Job Description
Job Type: Remote Education: MD/DO 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, Innovative Trial Design, Immunology

Location: Remote (North Chicago, IL, USA)
Department: Immunology Development
Employment Type: Full-time

About AbbVie

AbbVie is a global biopharmaceutical company focused on developing innovative therapies across immunologyoncologyneuroscience, and eye care. Through cutting-edge research and transformative medicines, AbbVie aims to improve lives and address the challenges of tomorrow. For more information, visit AbbVie.com.

Role Overview

As an Associate Medical Director (AMD) for Innovative Trial Designs in Immunology, you will support the safety strategy for complex clinical trial designs in immunology programs. You will collaborate with cross-functional teams, develop best practices for patient safety, and ensure compliance with regulations to enable effective clinical trial execution.

Key Responsibilities

  • Trial Design and Safety: Apply immunology, pharmacology, and toxicology insights to design and monitor innovative clinical trials, ensuring patient safety.
  • Regulatory Compliance: Stay up-to-date with relevant regulations and guidelines to guide trial designs and safety measures.
  • Safety Strategy: Contribute to the development and implementation of combination safety management strategies, including SOPsaggregate reports, and SSLs.
  • Health Authority Interaction: Engage with health authorities to plan safety monitoring protocols, adaptive trial designs, and risk assessments.
  • Cross-functional Collaboration: Collaborate with immunology and other therapeutic area teams (e.g., oncology) to ensure alignment on safety measures and trial designs.
  • Technical Documentation: Contribute to the creation of pharmacovigilance documents, such as medical safety assessmentsregulatory responses, and risk management plans.

Qualifications

  • MD/DO with 2+ years of patient care experience (preferred).
  • 2+ years of experience in drug safety or related roles within the pharmaceutical industry.
  • Clinical trial experience (preferred).
  • Strong clinical judgment, independent decision-making skills, and technical writing proficiency.
  • Ability to collaborate across functions and work in a dynamic, cross-disciplinary team.
  • Fluency in English (both written and oral).

Additional Information

  • Benefits: Comprehensive package including medical, dental, vision, paid time off, retirement, and 401(k) options.
  • Compensation: Competitive salary with eligibility for short-term and long-term incentive programs.
  • Inclusion & Diversity: AbbVie values diversity and is committed to providing equal employment opportunities to all qualified individuals, regardless of background or protected status.