Director, Clinical Operations Study Management, Emea & Asia

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 Director of Clinical Operations Study Management, EMEA & Asia will be responsible for leading Clinical Operation teams in EMEA and Asia, overseeing the execution of clinical trials in oncology and neuroscience, or other therapeutic areas, as required. You will lead a diverse team, ensuring the successful planning, coordination, and management of clinical trials in compliance with regulatory standards and company objectives.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require), in either of our California, New York or New Jersey offices 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.

About You

You are a collaborative, agile leader with significant late phase oncology global clinical development experience in Europe and Asia, and have a passion for operational excellence, building and leading inhouse clinical operations and FSP study management teams. You possess a deep understanding of clinical trial regulations, guidelines, and the principles of Good Clinical Practice (GCP), ensuring strict compliance throughout the clinical trial process.

What You'll Do

• In collaboration with senior clinical operations management, build and lead inhouse clinical operations study management teams responsible for late phase operational delivery of protocols in the EMEA and Asia global regions. Manage clinical operations study management activities and personnel supporting EMEA and Asia.

• Oversee clinical study planning, execution, and closeout activities, in EMEA & Asia, ensuring compliance with all applicable regulations, guidelines, and company policies.

• Provide strategic guidance and direction to cross-functional study teams to ensure successful study execution.

• Ensure that clinical studies are conducted in accordance with approved protocols, ICH-GCP, EMEA, PMDA and other relevant regulations and guidelines.

• Manage study budgets, timelines, and resource allocation to ensure successful completion of studies.

• Develop and maintain strong relationships with study investigators, clinical vendors and other external partners.

• Provide regular updates on study progress to senior leadership and other stakeholders.

• Serve as a talent magnet, to manage, develop, coach and retain top Clinical Operations talent in the study teams. Set clear performance standards and hold self and organization accountable for achieving high quality, high impact results. Embrace metrics and high-performance standards.

Qualifications

• A post-graduate degree with 10+ years of relevant experience or a Bachelor's degree with 12+ years of relevant experience in clinical study management within the biotechnology, pharmaceutical, or healthcare industry. Significant experience managing international clinical studies in oncology, and directly managing global Clinical Operations personnel.

• Demonstrated independence, problem-solving abilities, self-motivation, resourcefulness and ability to work in a fast-paced team environment. High emotional intelligence.

• Exceptional communication skills with an ability to efficiently and productively communicate both orally and in writing. Experience presenting to senior leadership is required.

• In-depth knowledge of ICH-GCP, EMEA, PMDA guidelines and other relevant regulations and guidelines.

• Proven ability to manage international clinical studies within timelines and budget while maintaining high quality standards and patient safety.

• Strong leadership, with a demonstrated ability to work collaboratively with cross-functional teams across diverse cultures and global regions.

• Management expertise should cover management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery.

• Ability to work onsite at least 3 days a week.

• Ability to speak multiple languages, strongly preferred.

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 $200,000 to $218,500 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.