Scientific Director – SERM & Clinical Safety (Remote, India)

About the role

Alphanumeric is looking for a Scientific Director to lead safety evaluation, risk management and pharmacovigilance across clinical development and post‑marketing programs. The role provides scientific leadership for global safety decisions and supports regulatory interactions.

Key responsibilities

• Lead safety review and risk management activities for assigned products, evaluating data from clinical trials, post‑marketing sources and scientific literature.
• Support global regulatory submissions, draft responses to Health Authority RFIs and interact with health authorities.
• Provide protocol, safety and regulatory support to clinical development teams and participate in cross‑functional safety governance.
• Identify emerging safety concerns, recommend actions and ensure compliant safety strategies.

Required profile

• Advanced scientific or healthcare‑related degree (PhD, PharmD, MS, NP, RN or equivalent).
• Significant experience in clinical development, drug safety or pharmacovigilance, including responding to Health Authority RFIs.
• Strong analytical, scientific writing and communication skills; proficiency in English.
• Ability to work independently, escalate issues appropriately and collaborate in global cross‑functional teams.

Required skills

• Experience with protocol support and regulatory submissions.
• Familiarity with health authority interactions (FDA, EMA, PMDA, etc.).