Executive Medical Director, Drug Safety

Position

The Executive Medical Director will be responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This physician is expected to provide interpretation and summaries of drug safety information and provide input in the generation of safety reports (e.g., clinical safety assessments). They will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.

About You

You are a seasoned physician with deep expertise in drug safety and pharmacovigilance. Your background in clinical safety spans signal detection, risk management, and regulatory compliance, allowing you to confidently assess complex safety data from multiple sources. With a strategic mindset, you are skilled at navigating health authority interactions, authoring safety reports, and driving proactive safety measures across clinical programs. Your leadership experience enables you to oversee cross-functional teams and external vendors effectively, ensuring adherence to global regulatory requirements. Detail-oriented yet forward-thinking, you thrive in a fast-paced environment, leveraging your knowledge of safety databases, MedDRA, and evolving pharmacovigilance regulations to maintain the highest standards of patient safety. Above all, you are a collaborative leader who can communicate complex safety concepts with clarity, drive continuous improvement, and contribute to the overall success of a growing organization. 

What You’ll Do

• Provide oversight on all safety aspects of documents: clinical studies protocols, clinical study reports, IB, Labels (development and maintenance of the company core safety information) and SUSARS (safety reporting/submission).
• Represent safety in communications with health authorities such as the FDA.
• Assess safety signals and trends and proactively manage any potential safety issues.
• Formulate response strategies and author responses for health authority requests.
• Accountable for medical evaluation/interpretation of aggregate safety data including signal detection and evaluation, and ad hoc safety assessments.
• Perform medical review of serious adverse events from Eikon clinical trials.
• Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports (DSUR), final study reports, IB and other documents as needed.
• Lead development of Risk Management Plans, implementation and evaluation of their effectiveness.
• Ensure safety issues are communicated to the appropriate stakeholders in a timely fashion.
• Author analysis of similar events (AOSE) and individual case comments for ICSRs.
• Ensure Medical Safety activities are performed in compliance with all applicable regulations and company standards.
• Assist with oversight of the vendor performing medical review of ICSRs and aggregate report on behalf of Eikon.
• Maintain knowledge of global regulatory authority regulations including FDA and EMA.
• Contribute to the training, leadership and continuing education of department staff.

Qualifications

• MD or DO with 10 years of relevant experience.  
• Must have US medical board certification.
• Highly-developed scientific and analytical knowledge base and an excellent understanding of good pharmacovigilance practices and current regulations within drug safety.
• Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA.
• Thorough understanding of U.S. pharmacovigilance regulations, GCP and International Conference on Harmonization (ICH) guidelines.
• Extensive experience in authoring of all types of aggregate safety reports including setting a strategy to address potential safety issues.
• Extensive experience in partnering with vendors to achieve results.
• Skilled at negotiating with business partners or managing and influencing senior level leaders regarding matters of significance to the organization.
• Ability to think strategically at the executive level, implement change, incorporate innovation, and implement strategies throughout all levels of the organization.
• Ability to build and sustain trusted relationships both internally and externally.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $300,000 to $327,750 depending on skills, competency, and the market demand for your expertise.

Salary : $300,000 - $327,750