Clinical Development Medical, Associate Director

Responsibilities:
- Provide medical advice to study team for all medical issues during risk assessment and mitigation planning to enable quality, compliance, and patient safety.
- Ensure development of and adherence to the Safety Surveillance Review Plan (SSRP), including review of individual subject safety data and cumulative safety data (with safety risk lead as applicable).
- Monitor study safety issues and provide input to serious adverse event (SAE) reports with appropriate medical context (risk factors, medical history, and other relevant factors).
- Participate in the Safety Review Team to evaluate medical benefits/risks for targeted clinical indications.
- Review literature as needed to respond to safety questions from the Safety Review Team, Data Monitoring Committee (DMC), or other study bodies.
- Communicate safety information to sites and respond to safety questions.
- Contribute medical input to protocol development and updates to the clinical development plan.
- Ensure protocol and related documents (e.g., informed consent document) meet regulatory requirements and company policy and have been reviewed by IRB/IECs.
- Provide medical input into country feasibility.
- Provide clinical input to protocol/study team (as needed) for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, and data quality planning.
- Contribute to CRO/vendor selection to ensure studies follow protocol requirements, clinical plan expectations, and timelines (including medical/technical data integrity requirements).
- Contribute to interpretation of efficacy and safety data; support delivery of top-line reports and clinical study reports, ensuring quality and timeliness.
- Provide protocol-specific training to study team, investigators, and others.
- Interact with healthcare professionals at sites; interact with DMCs and steering committees as required.
- Notify study team personnel of changes in research activity and significant new adverse events.
- Monitor investigator compliance with protocol and regulatory requirements.
- Support issues resolution, study closeout, audit responses, and inspection readiness.
- Under supervision, author clinical sections of regulatory documents (e.g., Investigator Brochure, Annual Reports, Investigational New Drug sections, clinical study report).
- May co-author abstracts, posters, presentations, and publications; may contribute to protocol budget execution.
- Support clinical regulatory authority interactions as needed and liaise with Key Opinion Leaders (KOLs) and Principal Investigators (PIs) to build networks for new trials.

Qualifications:
- Medical degree (M.D./D.O. or equivalent).
- Licensed by a health authority to prescribe medicines (independent of supervision) for at least 1 year (post intern/houseman) and used the license in a patient care setting for at least 2 aggregate years.
- 0–4 years’ work experience.
- Ability to critically evaluate medical/scientific information.
- Excellent written and oral communication.
- Understands design, development, and execution of clinical programs and studies.
- Capacity to adapt to a fast pace and changing environment.

Preferred qualifications/skills:
- Documented work experience/knowledge of statistics.
- Training and experience in infectious diseases and/or infection control in a hospital setting.
- Experience with investigational clinical trials.
- Leadership experience (influencing/collaborating, coaching others, overseeing work to deliver outcomes).

Work location:
- Hybrid; live within commuting distance and work on-site an average of 2.5 days per week or more as needed.