[Hiring] Scientific Director @Alphanumeric Systems

Role Description

Alphanumeric is seeking a Scientific Director to support a global Safety Evaluation & Risk Management organization. This role is responsible for providing scientific leadership in the evaluation of product safety, benefit-risk management, and pharmacovigilance activities across clinical development and post-marketing programs. The successful candidate will be a strong scientific leader capable of independently managing safety issues, supporting regulatory activities, and contributing to strategic safety decision-making across global programs.

Location: Remote, based in India.

Employment Type: Full-Time | 1-Year Contract | Potential Extension

Working Hours: Candidates must be available to work within U.S. and/or U.K. business time zones.

Key Responsibilities

• Lead safety review and risk management activities for assigned products.
• Evaluate safety data from clinical trials, post-marketing sources, and scientific literature.
• Support global regulatory submissions and health authority interactions.
• Draft and review responses to Health Authority Requests for Information (RFIs).
• Provide protocol, safety, and regulatory support to clinical development teams.
• Participate in cross-functional safety governance and risk management activities.
• Identify emerging safety concerns and recommend appropriate actions.
• Collaborate with internal stakeholders to ensure scientifically sound and compliant safety strategies.

Qualifications

• Advanced scientific or healthcare-related degree (PhD, PharmD, MS, NP, RN, or equivalent).
• Significant experience in clinical development, drug safety, pharmacovigilance, or a related field.
• Experience responding to Health Authority RFIs.
• Strong protocol support and regulatory experience.
• Excellent analytical, scientific writing, and communication skills.
• Proficiency in English is mandatory.
• Ability to work independently and appropriately escalate issues when needed.
• Experience working effectively within global cross-functional teams.

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.