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Clinical Program Manager, Oncology, Asia
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**
**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 mínimal 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**
- PhD without experience or a Master's Degree with 3 years of relevant experience or a Bachelor's Degree with 5 years of relevant experience in life sciences, healthcare, or related field preferred.
- In-depth knowledge of ICH-GCP, EMEA guidelines and other relevant regulations and guidelines.
- Proficient in using clinical trial management systems (CTMS, RTSM, Veeva Vault suite) and electronic data capture (EDC) systems
- 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.
- Proficient in mandarin and fluent in English (strong reading, writing, and speaking skills and an ability to effectively communicate with colleagues and stakeholders at all levels) is strongly preferred.
- PMP certification is 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 $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 e
