- Job Type: Full-Time
- Function: Clinical Research
- Industry: Biotechnology
- Post Date: 11/20/2023
- Website: eikontx.com
- Company Address: 3929 Point Eden Way, Hayward, CA 94545
About Eikon TherapeuticsEikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the interface of biology, engineering and chemistry 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.
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.
We are seeking an experienced Senior Manager, Safety Scientist to join our team. The Senior Manager, Safety Scientist will be 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.
You are a Safety Scientist expert with a passion for drug discovery. You are analytical, detail-oriented, and you have an appreciation for compliance. You’re collaborative by nature with uncompromising integrity. You’re conscientious and pay almost obsessive attention to detail, documentation and organization are second nature.
What You’ll Do
- Manage timely and accurate processing, evaluation, and reporting of adverse events
- Support signal detection strategies including 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
- Author and prepare individual and aggregate periodic Safety Reports (deliver strategy)
- Provide strategic direction and oversight for the management of safety data across our portfolio of products
- Develop and implement policies and procedures for the management of safety data in compliance with regulatory requirements
- Author and maintain Drug Safety and Pharmacovigilance related documents; Example: SMP, SOPs and Work Instructions, and SDEA
- Represent the company in interactions with regulatory authorities regarding safety-related issues
- Contribute to preparation of relevant safety sections of clinical study reports, annual reports, expedited safety reports and other regulatory filing documents
- Advanced degree in life sciences, pharmacy, nursing or related field required; MD preferred
- Minimum of 3-5 years of experience in pharmacovigilance and drug safety in a biopharmaceutical company or a CRO
- Strong working knowledge of MedDRA and safety databases (ARGUS)
- Strong knowledge of global regulatory requirements related to pharmacovigilance and drug safety
- Excellent analytical skills with the ability to review and interpret complex safety data
- Strong written and verbal communication skills
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 $157,000 to $180,000 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.
In accordance with the Company’s duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA’s emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California’s Fair Employment and Housing Act, you will need to contact the Company’s Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.
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.