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Clinical Program Manager, Clinical Operations Study Management
4 months ago
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 Clinical Program Manager in Clinical Operations Study Management will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. 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. The successful candidate will work closely with cross-functional teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support operational excellence and world class clinical study management.
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 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
- 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 global regional Clinical Operations Study Management personnel, as required, to support operational excellence
- Ensure that clinical studies are conducted in accordance with approved protocols, ICH-GCP, EMEA, PMDA and other relevant regulations and guidelines
- Contribute to initiatives and projects adding value to Eikon Therapeutics
Qualifications
- Minimum of 8 years of related experience with a Bachelor's degree; or 6 years and a Master's degree; or a PhD with 3 years experience; or equivalent experience
- In-depth knowledge of ICH-GCP, EMEA 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.
- Ability to work onsite at least 3 days a week.
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 $143,000 to $156,750 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.
