Job FunctionsClinical Study ManagementOncology and Other Therapeutic Areas
Job RequirementsMinimum of 12+ years of experience with a Bachelor's degree or 10+ years of experience with a postgraduate degreeExperience in Clinical Study Management within the Biotechnology, Pharmaceutical, or Healthcare IndustrySignificant Experience Managing International Clinical Studies in Oncology and Directly Managing Global Clinical Operations Personnel
SkillsMicroscopesChemistry, Engineering, Computation, BiologyICH-GCP, EMEA, PMDA GuidelinesCollaborative LeadershipProblem-Solving AbilitiesResourcefulnessEmotional Intelligence
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 will be responsible for overseeing the execution of multiple global clinical trials in oncology and 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. 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 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.
About You
You are a collaborative, agile leader with significant oncology global clinical development experience, 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 operational delivery of protocols.
- Oversee clinical study planning, execution, and closeout activities, 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.
- Ensure that all study-related documents are accurate, complete, and filed appropriately.
- 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
- Typically requires a minimum of 12+ years of experience with a Bachelor's degree, or 10+ years of experience with a post graduate degree
- Experience in clinical study management within the biotechnology, pharmaceutical, or healthcare industry highly preferred.
- 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.
- Veeva clinical systems experience preferred.
- MS Project experience 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 $226,000 to $247,000 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.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.
Life at Eikon Therapeutics
Thrive Here & What We Value1. Passion for innovation and improving patient outcomes. | 2. Daily subsidized lunch program when onsite. | 3. Generous paid time off and holiday policies. | 4. Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employeepaid life/AD&D policies | 5. Enhanced parental leave benefit. | 6. Weeklong summer and winter holiday shutdowns. | 7. Mental health and wellness benefits.</s> | Equal Opportunity Employer | Generous Benefit Programs | Daily Subsidized Lunch Program</s> | Eikon Therapeutics is committed to creating a positive and inclusive workplace culture that values collaboration, innovation, and creativity. | The company offers generous benefits 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, 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. | Daily subsidized lunch program when on-site | Enhanced parental leave benefit</s> | 1. Innovative and forwardthinking approach to drug discovery | 2. Emphasis on collaboration and teamwork | 3. Focus on creating novel treatments for lifethreatening diseases | 4. Commitment to equal opportunity employment | 5. No thirdparty agencies or firms currently being considered</s> | 1. Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for lifethreatening diseases. | 2. 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, molecularresolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. | 3. 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 employeepaid life/AD&D policies, Enhanced parental leave benefit, Daily subsidized lunch program when on-site.</s> | 2. 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, molecularresolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. | Eikon Therapeutics is committed to discovering novel treatments for life-threatening diseases using groundbreaking innovations from its founders. | The company's discovery platform is built on revolutionary technology at the intersection of Chemistry, Engineering, Computation, and Biology. | Eikon values collaboration, agility, and operational excellence in building and leading in-house clinical operations study management teams.</s> | Mental health and wellness benefits</s> | 1. Eikon Therapeutics is an equal opportunity employer and will consider all qualified applicants for employment. | 2. Employee compensation includes bonus and equity compensation, in addition to several generous benefit programs. | 3. Daily subsidized lunch program when onsite. | 4. Weeklong summer and winter holiday shutdowns. | 5. Generous paid time off and holiday policies. | 6. Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employeepaid life/AD&D policies | 7. Enhanced parental leave benefit.</s> | Eikon Therapeutics is committed to creating an inclusive culture that values diverse perspectives, experiences, and backgrounds. | The company offers generous benefits programs, including medical, dental, and vision insurance, mental health and wellness benefits, paid time off, holiday policies, life/AD&D Insurance, parental leave benefit, and daily subsidized lunch program when on-site.</s> | 3. Focus on making a positive impact on patients' lives through novel treatments for lifethreatening diseases | 4. Supportive and inclusive work environment | 5. Opportunities for professional growth and development</s> | 1. Eikon Therapeutics is committed to creating a diverse and inclusive workplace culture that values collaboration, innovation, and excellence. | 2. The company offers generous benefits 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, paid time off and holiday policies, life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employeepaid life/AD&D policies. | 3. Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.</s> | 1. Employee compensation includes bonus and equity compensation, in addition to several generous benefit programs. | 2. Generous paid time off and holiday policies | 3. Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employeepaid life/AD&D policies | 4. Enhanced parental leave benefit | 5. Daily subsidized lunch program when onsite</s> | 3. Focus on improving patient outcomes through novel treatments | 4. Commitment to scientific excellence and integrity | 5. Support for professional development and growth</s> | 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%) | Daily subsidized lunch program when on-site</s> | 1. Dedication to promoting a culture of safety, sustainability, and compliance in a dynamic biotech environment | 2. Generous benefit programs, including 401k plan with company matching, medical, dental, and vision insurance, mental health and wellness benefits, weeklong summer and winter holiday shutdowns, paid time off and holiday policies, life/AD&D Insurance (premiums covered by Eikon at 100%), enhanced parental leave benefit, daily subsidized lunch program when onsite.</s> | 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. | At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including: 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.</s> | 2. Collaborative and supportive environment | 3. Emphasis on teamwork and communication | 4. Focus on making a positive impact in the world through novel treatments for lifethreatening diseases | 5. Commitment to equal opportunity employment</s> | 1. Equal Opportunity Employer | 5. Enhanced Parental Leave Benefit</s>
