Medical Director, Global Safety Physician

🔥 2 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $180k - $240k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Belite Bio

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2018

🧬 Biotechnology

💊 Pharmaceuticals

🔥 Funding within the last year

💰 $402M Post-IPO Equity on 2025-12

Biotechnology • Pharmaceuticals

Belite Bio is a clinical-stage biopharmaceutical company developing novel therapeutics based on its RBP4 (Retinol Binding Protein 4) intellectual property portfolio. Its lead candidate, tinlarebant (LBS-008), is an oral therapy designed to reduce toxic accumulations in the eye and is being developed for retinal degenerative diseases including autosomal recessive Stargardt disease (STGD1) and Geographic Atrophy (advanced dry age-related macular degeneration). Belite Bio is conducting multiple clinical trials (Phase 1b/2, Phase 2/3, and Phase 3 programs such as DRAGON, DRAGON II, and PHOENIX) and tinlarebant has received several regulatory designations (Orphan Drug in US/EU/Japan, Rare Pediatric Disease, Breakthrough Therapy, Fast Track, and Sakigake). The company’s pipeline also includes programs addressing metabolic and liver diseases (e. g. , non-alcoholic fatty liver disease and type 2 diabetes).

📋 Description

• Lead medical assessment and interpretation of safety data from clinical trials, literature reports and multiple other sources • Collaborate with cross-functional teams in support of clinical development programs, regulatory filing and global safety activities • Support the clinical R&D team in oversight of pharmacovigilance service vendors and partners • Maintain current medical knowledge and knowledge of drug safety and pharmacovigilance regulations, practices, safety surveillance and risk-management practices • Provide medical safety input and participate in safety surveillance, including identifying safety signals and ensuring timely assessment and communication of confirmed signals • Provide input into aggregate safety reports, including DSURs, PADERs and PBRERs • Provide input to study protocols, amendments, safety plans, clinical study reports, eCRFs/CRFs and TMFs • Manage internal and external forums, including external Data Monitoring Committees and Safety Management Teams, for assigned products and studies • Collaborate with Medical Monitors, Clinical Research Scientists and vendor clinical staff for ongoing clinical trials • Provide input into development and updates of Risk Management Plans • Support development of Standard Operating Procedures, Working Instructions and other guidance documents • Respond to and resolve safety questions from health authorities and support regulatory agency audits and inspections • Provide safety guidance, oversight and training to employees, CROs and site investigators • Serve as a subject matter expert for CRO vendors providing drug safety and pharmacovigilance services • Train and mentor teams on emerging safety aspects, PV processes, technologies and new regulations • Reports directly to the Head of Medical Safety, Global Pharmacovigilance

🎯 Requirements

• 5+ years’ experience in Drug Safety/Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency • Medical Degree (MD) from a recognized international medical school • At least 3 years of residency training and medical practice experience • Board-certified Ophthalmologist with drug discovery and clinical development experience strongly preferred • Strong working knowledge of US and EU drug safety and pharmacovigilance regulations, CIOMS and ICH guidelines • Proven experience in medical safety assessments, safety surveillance and risk management activities • Extensive knowledge and clinical judgment in safety signal management, medical review, aggregate safety assessment and benefit–risk decision-making across clinical development and post-marketing products • Extensive knowledge of common safety databases (Oracle Argus Safety and/or Aris Global) • Knowledge of MedDRA coding • Experience with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and analysis of similar events and company comment statements including benefit-risk assessment • Experience authoring aggregate reports (DSUR, PSUR/PBRER, PADER) • Experience preparing responses to regulatory authorities • Experience with regulatory filing and related activities preferred • Demonstrated success in cross-functional influence and stakeholder management as global medical safety leader • Extensive experience interacting with global health authorities and leading safety-related regulatory activities • Strong understanding of global pharmacovigilance regulations and industry best practices • Ability to influence cross-functional and executive-level decision-making and build effective partnerships across Patient Safety/Pharmacovigilance, Clinical Science, Regulatory Affairs, Medical Affairs and Biometrics

🏖️ Benefits

• Annual incentive bonuses • Equity participation • Health insurance • Dental insurance • Vision insurance • 401(k) • Paid time off • Reasonable accommodations for individuals with disabilities

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