Job Description
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Please note that starting April 2025, Eikon Hayward positions will be moving to our new headquarters in Millbrae, CA
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.
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.
Ensure Medical Safety activities are performed in compliance with all applicable regulations and company standards.
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.
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes. Eikon Therapeutics
Job Tags
Holiday work, Summer holiday,