Associate Director, Clinical Study Management, EMEA/LATAM
Eikon TherapeuticsJersey City, New Jersey, United States · Posted 1 month agoDescription
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 Associate Director, Clinical Study Management, EMEA/LATAM will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. This role will require onsite presence a minimum of 3 days a week to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. The successful candidate will work closely with cross-functional Clinical Research & Development teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support operational excellence and world class inhouse clinical study management.
This role requires a minimum of 3 days per week onsite (or more, as business needs require) in either our Jersey City (NJ), or Millbrae (CA) offices.
About You
You are collaborative, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology or neuroscience.
What You’ll Do
- Team leader and builder, who manages trial deliverables, timelines in assigned protocols across EMEA and LATAM to meet country commitments and regulatory requirements.
- Works with minimal oversight from Clinical Operations Senior Director or Director, in collaboration with Clinical Operations teams and Clinical Research and Development functional teams.
- Ensure that clinical studies are conducted in accordance with approved protocols, ICH-GCP, EMEA, PMDA and other relevant regulations and guidelines.
- Manage ancillary (non CRO) vendor relationships and performance to ensure that clinical studies are completed in accordance with contract specifications of time, cost and quality ensuring compliance with applicable regulations, guidelines, and company policies.
- Work with finance, legal, external vendors and clinical sites to ensure the assigned studies are meeting the target milestones.
- Proven experience managing multi-center global clinical trials (Phases I–IV), with familiarity with regional nuances.
- Keep up to date with regional regulations, health authority frameworks, treatment landscape and country requirements.
- Manage regional resource planning, budgeting, forecasting, and key performance indicators (KPIs) for the region.
- Provide direction to cross-functional study teams to ensure successful study execution.
- Provide regular updates on study progress to stakeholders (e.g., Clinical Operations, Project & Portfolio Management, Clinical Research).
- Ensure that all study-related documents are accurate, complete, timely and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems.
- Oversee and be in compliance with Eikon processes, SOPs, clinical supply and ancillary supplies management, import/export requirements, insurance supply management.
- Expected to lead, manage, hire regional Clinical Operations Study Management personnel across EMEA and LATAM, as required, to support operational excellence.
- Contribute to initiatives and projects adding value to Eikon Therapeutics.
Qualifications
- Minimum of 10 years of related experience with a Bachelor’s degree; or 8 years and a post graduate degree.
- Fluency in English (strong reading, writing, and speaking skills and an ability to effectively communicate with colleagues and stakeholders at all levels) is required and ability to speak multiple EMEA/LATAM languages is a plus for this role.
- In-depth knowledge of ICH-GCP, EMEA/LATAM guidelines and other relevant regulations and guidelines.
- Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety.
- Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams.
- Experience with management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery.
- High sense of accountability and urgency in order to prioritize deliverables.
- Growth mindset and capable of working independently.
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 $183,000 to $220,500 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.
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.
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