Senior Manager, Safety Scientist

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.

Position

The Senior Manager, Safety Scientist responsible for the management of safety data across our portfolio of products. The successful candidate will play a critical role in ensuring the safety of our patients by proactively monitoring and assessing adverse events, as well as working cross-functionally to ensure compliance with regulatory requirements.

About You

The successful candidate will play a critical role in ensuring the safety of our patients by proactively monitoring and assessing adverse events, as well as working cross-functionally to ensure compliance with regulatory requirements.

What You'll Do

• Manage timely and accurate processing, evaluation, and reporting of adverse events.
• Provide strategic direction and oversight for the management of safety data across our portfolio of products.
• Risk Management evaluation (deliver strategy, preparation and authoring.
• Involved in Periodic Safety Reports (deliver strategy and preparation).
• Collaborate with clinical development teams to ensure the safety of patients enrolled in clinical trials.
• Involved in signal detection strategies which includes design and performing analyses of safety information for signal detection.
• Review and analyze safety data, identify emerging safety issues, and communicate findings to cross-functional teams.
• Develop and implement policies and procedures for the management of safety data in compliance with regulatory requirements.
• Other assigned tasks as needed.
• Represent the company in interactions with regulatory authorities regarding safety-related issues.

Qualifications

• MD Degree strongly preferred. PharmD , PhD degree in life sciences, pharmacy, nursing, or a related field.
• Excellent analytical skills with the ability to review and interpret complex safety data.
• Strong written and verbal communication skills.
• Strong knowledge of global regulatory requirements related to pharmacovigilance and drug safety.
• Minimum of 4 years of experience in pharmacovigilance and drug safety in a biopharmaceutical company or a CRO.

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

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

The expected salary range for this role is $157,000 to $180,000, depending on skills, competency, and the market demand for your expertise.