Role: Associate Medical Director

Location: remote but must be located in the US (no CA resources)

Rate: upto $55/hr

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We are seeking a highly motivated and experienced Associate Medical Director to provide critical medical and scientific expertise for our therapeutic programs. This role is essential for driving clinical strategy, ensuring patient safety, and delivering accurate scientific communications.

Key Responsibilities:

The Associate Medical Director will work closely with the Medical Director and cross-functional teams to execute and support the clinical and scientific strategy for assigned products within a specific Therapeutic Area (TA).

1. Clinical Strategy and Execution

• Protocol Development: Provide medical and scientific input into the design, writing, and finalization of clinical study protocols, informed consent forms, and study-related documents (e.g., Investigator’s Brochures).
• Medical Monitoring: Serve as the Medical Monitor for assigned clinical trials, addressing study-related medical questions, resolving clinical and safety issues, and ensuring study integrity in compliance with Good Clinical Practice (GCP).
• Data Analysis: Participate in the review, interpretation, and communication of clinical data, including interim analyses, Clinical Study Reports (CSRs), and publications.
• Translational Strategy: Contribute to the strategic development of early-phase or translational studies (if applicable).

2. Drug Safety and Pharmacovigilance

• Safety Review: Perform and/or oversee the medical review and analysis of individual Serious Adverse Event (SAE) reports and aggregate safety data.
• Signal Detection: Partner with Pharmacovigilance to monitor the evolving safety profile of assigned products, supporting signal detection and risk management activities.
• Regulatory Reporting: Provide medical input and review of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and other regulatory safety documents.

3. Scientific and External Engagement (Medical Affairs Focus)

• KOL Engagement: Develop and maintain professional relationships with Key Opinion Leaders (KOLs), investigators, and external experts to gather medical insights and support scientific exchange.
• Medical Content Review: Provide scientific and medical review of promotional materials, medical information responses, and educational initiatives to ensure accuracy and compliance.
• Publication Strategy: Contribute to the planning and development of scientific publications, abstracts, and presentations based on study data.

4. Compliance and Leadership

• Cross-Functional Collaboration: Serve as the medical/scientific expert on cross-functional teams (e.g., Clinical Operations, Regulatory Affairs, Commercial) to ensure alignment between medical strategy and business objectives.
• Regulatory Interaction: Assist in preparing for and participating in interactions with global regulatory agencies (e.g., FDA, EMA) as a subject matter expert.
• Training: Provide medical and therapeutic training to internal teams (e.g., Clinical Operations, Medical Science Liaisons).

Qualifications and Experience:

• Typically 3+ years of clinical development, medical affairs, or pharmacovigilance experience in the pharmaceutical or biotechnology industry.
• Demonstrated understanding of the drug development lifecycle, from Phase I through post-marketing.
• Solid working knowledge of global regulatory requirements and guidelines (e.g., ICH, GCP, FDA, EMA).
• Strong ability to critically analyze, interpret, and present complex scientific and clinical data.
• Exceptional written and verbal communication and presentation skills.
• Proven ability to work collaboratively in a matrix environment and influence without direct authority.
• Strong leadership capabilities and business acumen

If you are interested in this opportunity, please apply today.

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