Director, Vaccines Clinical Research (MD required)

Role Summary:
- Accountable for providing medical and scientific expertise and oversight for Clinical Trials; single point of accountability for design, execution, monitoring, delivery, and reporting of one or more clinical studies to ensure patient safety.
- May design development strategy for multiple protocols for worldwide approval.
- May participate in standing committees, review compounds for in-licensing (including due diligence), and aid new business development.

Role Responsibilities:
- Provide medical advice for medical issues during risk assessment and mitigation planning.
- Ensure development of and adherence to the Safety Surveillance Review Plan (SSRP).
- Perform and document review of individual subject safety data and cumulative safety data with the safety risk lead (may delegate to study clinician scientist).
- Monitor study safety issues; provide input to serious adverse event (SAE) reports and provide medical context for benefit-risk assessments.
- Participate in Safety Review Team; review literature as needed for safety questions.
- Communicate safety information to sites.

Protocol design and strategy:
- Provide medical input into development and updates to the clinical development plan.
- Design clinical studies to meet objectives; ensure alignment with clinical program strategy.
- Ensure protocol/ICD meet regulatory requirements and are reviewed by IRB/IECs; provide input to country feasibility.

Support study and program teams:
- Provide clinical input to monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, and data quality planning; oversee protocol/study team.
- Contribute to CRO/vendor selection; ensure data integrity requirements.
- Conduct medical review of efficacy and safety; support top-line and clinical study report preparation and ensure validity and timeliness.
- Ensure disclosure of appropriate safety and efficacy data/conclusions.
- Provide protocol-specific training; interact with sites, DMCs, and steering committees; monitor investigator compliance; support issues resolution, closeout, audits, and inspection readiness.
- Author clinical regulatory document sections (e.g., Investigator Brochure, Annual Reports, IND sections, clinical study report). May co-author publications/abstracts; may contribute to budget execution.
- Support Clinical Regulatory Authority responses; liaise with KOLs/PI network for new trials.

Basic Qualifications:
- Medical degree (M.D./D.O. or equivalent).
- 4+ years’ work experience.
- Licensed to prescribe medicines independently for at least 2 years (post intern/houseman) and used license in patient care for at least 1 year.
- Ability to critically evaluate medical/scientific information.
- Understanding of clinical program/study design, development, and execution.
- Documented pharmaceutical industry experience related to clinical research and registration activities.
- Experience managing multiple studies.

Preferred Qualifications:
- Documented work experience/knowledge of statistics.
- Infectious diseases and/or infection control experience (hospital setting).
- Experience with investigational clinical trials.
- Excellent written and oral skills.
- Ability to adapt to fast pace and changing environment.
- Demonstrated leadership capabilities (influence/collaboration, coaching, guiding others, business impact).

Application Instructions:
- Not specified in provided text.