[Hiring] Medical Director @Alphanumeric Systems

Role Description

Alphanumeric is hiring a SERM Medical Director (Remote, 1-Year Contract with possibility of extension) to work for one of the biggest pharmaceutical companies in the world. This role will provide medical leadership for the safety evaluation, benefit-risk assessment, and risk management of products in clinical development and post-marketing settings.

• Lead safety evaluation and benefit-risk assessments for assigned products.
• Support pharmacovigilance and risk management activities across clinical development and marketed products.
• Contribute to regulatory submissions and health authority interactions.
• Prepare and review scientifically sound responses to Health Authority Requests for Information (RFIs).
• Analyze and interpret clinical and safety data to support regulatory and business decisions.
• Participate in cross-functional safety governance and product safety discussions.
• Provide protocol and regulatory support throughout the development lifecycle.
• Escalate significant safety concerns and emerging risks when appropriate.

Qualifications

• MD or equivalent physician qualification.
• Significant experience in clinical development, drug safety, pharmacovigilance, or related pharmaceutical functions.
• Experience responding to Health Authority RFIs.
• Strong understanding of benefit-risk assessment and safety evaluation.
• Experience supporting regulatory submissions and regulatory authority interactions.
• Excellent scientific writing and communication skills.
• Proficiency in English is mandatory.
• Ability to work independently in a fast-paced, highly matrixed environment.

Requirements

• Location: Remote, based in Portugal.
• Employment Type: Full-Time | 1-Year Contract | Potential Extension.
• Model: 100% from home.
• Salary: 120,000.00 EUR + benefits.
• Working Hours: Candidates must be available to work within U.S. and/or U.K. business time zones.

Preferred Qualifications

• Oncology experience is highly desirable but not required.
• Experience interacting with FDA, EMA, PMDA, and other global regulatory agencies.
• Experience supporting global development programs.