Medical Director/Sr Medical Director, Drug Safety & Pharmacovigilance

10+ years

Not Disclosed

Remote, USA

10 Nov. 5, 2024

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

Job Title: Medical Director/Sr. Medical Director, Drug Safety & Pharmacovigilance
Location: Remote (with occasional travel to headquarters)
Company: Viridian Therapeutics

Company Overview

At Viridian Therapeutics, we are dedicated to developing best-in-class medicines for patients suffering from autoimmune and rare diseases. By leveraging our team’s expertise in antibody discovery and engineering, we have built a robust pipeline of differentiated investigational therapies targeting well-validated disease mechanisms. We prioritize data-driven decisions, thoughtful risk-taking, and the efficient use of resources to maximize the success of our innovative treatments. We value open communication, transparency, and fostering a culture that empowers employees to contribute at a high level while balancing their personal and professional lives.

Job Summary

Viridian Therapeutics is seeking an experienced and accomplished Medical Director/Sr. Medical Director in Drug Safety & Pharmacovigilance to provide critical leadership in monitoring and evaluating the safety profiles of our investigational products. Reporting to the Vice President, Pharmacovigilance, this position will oversee key medical safety activities within the Pharmacovigilance (PV) department. The role requires expertise in safety signal detection, risk-benefit analysis, and clinical trial safety management. The Medical Director will also be responsible for collaborating across multiple functions, including clinical development, biostatistics, clinical operations, and medical affairs.

This role is fully remote for non-local candidates, with occasional travel to Viridian’s headquarters as required by management. Office-based employees will be required to work in the office three days a week.

Key Responsibilities

Medical Safety Expertise

Provide medical and scientific expertise in Drug Safety and Pharmacovigilance activities, including signal detection, risk-benefit assessments, and safety evaluations for assigned products.
Lead quarterly Safety Management Team (SMT) meetings, analyzing safety data from clinical trials, non-clinical studies, literature, and competitive intelligence.
Collaborate with the Vice President, Pharmacovigilance to implement clinical strategies across various stages of drug development, particularly mid to late-stage development and post-commercialization.
Develop and execute safety strategy for clinical studies, reviewing safety data regularly and responding to emerging safety issues.
Review and interpret clinical data to enable program go/no-go decisions and contribute to regulatory submissions.

Cross-Functional Collaboration

Contribute to the creation and revision of Investigator Brochures (IB), Risk Safety Reports (RSIs), and other regulatory documents.
Oversee the preparation and management of aggregate safety reports such as DSURs, PSURs, NDA Periodic Reports, and IND Annual Reports.
Provide input and oversight for safety and pharmacovigilance issues in clinical development documents, including protocols, INDs, CTAs, and regulatory responses.
Collaborate across teams to ensure seamless communication and decision-making for all safety-related matters.

Medical Affairs and Stakeholder Management

Contribute to the Medical Affairs strategy, focusing on external stakeholder management, patient identification, evidence generation, publications, and medical education.
Provide support for the development of Health Authority responses and contribute to ad-hoc safety assessments and investigations.

Regulatory and Compliance Activities

Oversee SAE (Serious Adverse Event) and SUSAR (Suspected Unexpected Serious Adverse Reaction) review, ensuring compliance with regulatory reporting requirements.
Monitor safety risk minimization measures and ensure appropriate oversight of outsourced pharmacovigilance activities.
Participate in the development of Standard Operating Procedures (SOPs) and Work Instructions (WIs) for PV activities.

Requirements

Education & Experience

Medical Doctor (MD) degree required.
At least 7+ years of experience in pharmacovigilance or a related field, including safety signal detection, case processing of SAEs, and preparing regulatory documents.
Proven expertise in preparing aggregate safety reports such as DSURs, PSURs, NDA Periodic Reports, and IND Annual Reports.
In-depth knowledge of FDA, EMA, and ICH guidelines governing safety reporting and processing in clinical trial environments.
Thorough understanding of MedDRA and WHO Drug Dictionary terminology, as well as experience with safety databases like Argus.

Skills & Competencies

Strong understanding of Risk Management principles and activities.
Ability to navigate the drug development process with a focus on safety surveillance.
Proven ability to collaborate across functional teams and communicate effectively with both internal and external stakeholders.
Hands-on, entrepreneurial mindset with the ability to work in a fast-paced, dynamic environment.
Experience in vendor management and oversight of outsourced activities.
Excellent organizational and time-management skills, with the ability to prioritize and manage competing demands.
Strong verbal and written communication skills, including the ability to present complex safety data to various stakeholders.

Travel Requirements

Approximately 10-15% travel may be required for meetings and site visits.

Compensation & Benefits

Competitive salary and stock options for all employees.
Comprehensive benefits package, including medical, dental, and vision coverage (100% premiums paid for employees and dependents).
Fertility and mental health programs, disability coverage, life insurance, and 401(k) match with immediate vesting.
Generous vacation and paid company holiday shutdowns.
Access to various mental, financial, and physical health programs.

Viridian Therapeutics is an Equal Opportunity Employer

Viridian Therapeutics provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, and local laws. We ensure reasonable accommodation for individuals with disabilities throughout the hiring process.