Senior Director, Study Start Up
- 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 disease. 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 of proteins as drug targets.
We are currently seeking an experienced, innovative leader for the role of Senior Director Study Start Up. In this role you will work with the SVP of Clinical Development Operations and the clinical trial teams to improve operational excellence and efficiency of clinical trial execution in study and site start up across all phases of Clinical Development activities at Eikon Therapeutics by:
- Driving study feasibility deliverables and providing data driven recommendations to accelerate clinical trials
- Supporting Clinical Development Operations Study Planning: to ensure proper planning and timely execution of all clinical trials, and associated plans are developed and in place before start of study
- Identifying and implementing industry clinical site technology best practice solutions to ensure support of Site communications and engagement (Sponsor of Choice).
You are a collaborative leader with a passion for solving operational challenges, with an agile and adaptive mindset, and relentless in your pursuit of excellence.
What You’ll Do
- Leading and evolving the business processes for study, country and site feasibility, scenario modelling and enrollment projections to support and create efficient clinical trials at scale and drive enrollment to increase access to scientific advancements
- Working closely with Clinical Development R&D functions, enhance analytic capabilities to ensure the right questions are being asked and data is being leveraged to drive study feasibility deliverables and provide data driven recommendations to accelerate our clinical trials in study design and study start up
- Guide internal and external partners on study start up activities
- Act as subject matter expert (SME) for country landscape knowledge to drive accelerated start up timelines, provide guidance on activation trends and make recommendations to clinical trial teams to leverage the clinical trial environment, patient and trial networks
- Perform proactive risk assessment to anticipate study specific challenges, communicate to internal and external business partners to mitigate risk
- Identify industry innovation opportunities in study start up and bring best practices to Eikon Therapeutics
- Build and lead a team of individuals who support clinical trial teams through the study start up and execution stages
- Engage and develop strong working relationships with clinical study teams (e.g., Clinical Operations, Clinical Supply, Legal, Regulatory, Clinical IT, Clinical R&D Process and Learning Management, Clinical Project and Portfolio Management, Clinical Quality Assurance, Clinical Data Management, and Clinical Research)
- Define the standards for planning and execution of study start up, country requirements, working in collaboration with Clinical Operations on site information management activities to ensure time critical and high-quality delivery of study specific needs
- Ensure the real time collection of information that informs country allocation, investigator site identification through activation, forecasting and planning and contributes to accurate site activation deliverables
- Identifies, assesses and contributes to the successful implementation of technology solutions that better enable site engagement, communication, document exchange, etc. and site performance in support of study / site start up activities
- Support Clinical Development Operations in driving a partnering mindset
- Serve as a talent magnet and develop, coach, and retain top talent in the team. Set clear performance standards and holds self and organization accountable for achieving results. Embrace metrics and performance standards (KPIs).
- Master’s degree with a minimum of 10 years or Bachelor’s degree with a minimum of 15 years of experience in a pharmaceutical industry or other clinical research setting with clinical trials; 7+ years of supervisory experience required
- Solid understanding of US and global regulations and guidelines (e.g., FDA, EMEA, ICH) applicable to clinical development; prior success in partnering with regulatory peers to support timely and quality regulatory submissions
- Extensive experience within the pharmaceutical industry or clinical research organization (CRO) working with clinical data and clinical development processes. Deep understanding of complexities of study start up
- Strong analytical and project management skills
- Able to manage complexity, by asking the right questions, securing data from multiple and diverse sources in order to accurately analyze situations to uncover the root cause and solve business challenges
- Able to rapidly adapt to changes in the work environment, manage competing demands and change approach or method to achieve optimal fit-for-purpose solution
- Excellent verbal / written communication and collaboration skills and ability to influence at all levels across functions and build effective relationships in a matrix organization
- Management expertise should cover management of budget, resources, headcount, processes (and controls), productivity, quality and project delivery
- Experience with Veeva clinical solutions (i.e., beyond solely eTMF Vault)
- Strategic thinking and high emotional intelligence.
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 $230,000 to $265,000 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.