Job description

Position: Contract Medical Director Lead (Title flexible to Medical Director/VP Level)
Hours: 10-15 hours per week
Location: Flexible but ideally Boston MA

Overview

We are seeking a highly qualified Medical Director with expertise in autoimmune/rheumatology, specifically for lupus, to join our team on a contract basis. This role requires a candidate with significant industry experience in medical monitoring, particularly within Phase 1 clinical trials, and a strong background in pharmacovigilance and safety assessment.

Key Responsibilities

Medical Monitoring: Oversee medical monitoring for Phase 1 trials, focusing on the safety and tolerability of products.
Clinical Leadership: Provide clinical leadership and program management, working closely with the clinical team to execute trials and study protocols.
Patient Population and Disease Activity: Monitor and select the patient population, assess disease activity, and ensure proper training of PIs.
Operational Activities: Participate in startup activities, eligibility reviews, and other operational tasks.
Collaboration: Work closely with our field medical monitor, a board-certified rheumatologist, and other clinical team members.
Regulatory and Efficacy: As trials progress to Phase 2 and 3, ensure compliance with regulatory requirements and focus on trial efficacy.

Qualifications

Experience: Must have industry experience in medical monitoring and pharmacovigilance for Phase 1 trials.
Background: Strong background in immunology or autoimmune diseases, with lupus experience highly preferred.
Clinical Trials: Experience in leading clinical trials, particularly in immunology or rheumatology, is essential.
Expertise: Must be capable of coding drug-related matters and have a deep understanding of safety assessments.
Collaboration Skills: Ability to work closely with clinical teams and external partners