ROLE SUMMARY

The Medical Director provides Clinical Development leadership and expertise on clinical trials, including overseeing the design, conduct, and analysis. The Medical Director works closely with other functions such as regulatory affairs, pharmacovigilance, biostatistics, and medical affairs to ensure that the clinical development program meets the scientific, ethical, and regulatory standards. The Medical Director also provides medical expertise and guidance to the clinical operations team, the investigators, and the external stakeholders such as health authorities, ethics committees, and patient advocacy groups.   

ROLE RESPONSIBILITIES

Study-level Clinical Development Leadership

• Collaborate with Clinical Scientist(s) to provide clinical leadership across 2-3 study team(s) that is scientifically rigorous and aligns with company objectives.
• Conduct medical monitoring activities including eligibility assessment, data review and safety monitoring.
• Lead peer-to-peer interactions with investigators.
• Serve as the point of contact for clinical issues between the study team, investigators, ethics committees, steering committees, and regulatory authorities.
• Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional team.

Strategic Guidance, Clinical Insights & Interpretation

• Collaborate with Clinical Scientist to review and interpret clinical data, identify key findings and implications, and communicate to internal and external stakeholders.
• Maintains a high level of clinical expertise and professional competence by staying abreast of the latest developments, literature, and guidelines to advise on and drive current and future clinical development plans.

QUALIFICATIONS:

• Medical degree (MD)
• Relevant clinical or industry experience considered
• 2-5 years industry experience

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Ability to travel to relevant international scientific congresses and internal team meetings 3-6 times per year.

Work Location Assignment: Hybrid

Medical