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
We are seeking a Senior Manager of Study Start-Up to join our Clinical Operations team. In this role, you will lead the study start-up activities for clinical trials, ensuring efficient and compliant initiation of studies. This role will require onsite presence a minimum of 3 days a week onsite in our offices to ensure effective global clinical trial management.
About You
You are collaborative and passionate about unlocking hidden insights in today's clinical operations landscape and relentless in your pursuit of operational excellence.
What You'll Do
- Manage the study start-up process for clinical trials, including country and site identification & selection, feasibility assessments, and regulatory submissions.
- Collaborate closely with cross-functional teams and key stakeholders (Study Management, Site Engagement & Monitoring Excellence, Clinical Sciences, Regulatory Operations, Clinical Supply, Legal and Finance) to develop and execute study start-up plans in alignment with project timelines and objectives.
- Manage the collection and summarization of data and generation of study start up insights (eg. Metrics, KPIs, Industry Benchmarks, etc.) for Clinical Operations and clinical trial team's consideration to improve Study Start Up turn around times.
- Oversee the preparation, submission and collection of Study, Country & Site Essential documents in support of IMP shipment to sites.
- May oversee the development, negotiation and finalization of Site Contracts & Budgets in support of scheduling and conduction Site Initiation Visits and Site Activation.
- Develop and maintain strong relationships with investigative sites, vendors, and internal stakeholders to facilitate study and site start-up activities.
- Proactively identify and address potential study & site start-up challenges or bottlenecks to optimize site activation timelines.
- Ensure compliance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and internal standard operating procedures (SOPs) throughout the study start-up phase.
- Participate in process improvement initiatives to enhance the efficiency and quality of study start-up processes.
Qualifications:
- A Post Graduate Degree with 6+ years of relevant experience or a Bachelor's Degree with 8+ years of relevant experience in life sciences, healthcare, or a related field.
- Strong knowledge of clinical trial start-up processes, regulatory requirements, and industry standards.
- Proven ability to successfully manage multiple clinical trials simultaneously from start-up to close-out.
- Excellent project management skills with a focus on delivering results within established timelines and budgets.
- Strong interpersonal and communication skills, with the ability to build effective relationships with internal and external stakeholders.
- Detail-oriented and organized, with the ability to prioritize tasks and adapt to changing priorities in a fast-paced environment.
- Knowledge of Clinical Trial Management System (CTMS) and electronic trial master file (eTMF) systems and supporting study start-up technologies.
- Familiarity with Study/Country/Site Feasibility assessment systems and tools
- Experience with scenario modeling and generation of country and site activation forecasts
- Certification in clinical research (e.g., ACRP, SoCRA) or project management (e.g., PMP) is a plus.
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 $148,000 to $161,500 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.