Manager, Clinical Operations – Early Development, Oncology

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Provide strategic and operational oversight for early development and clinical pharmacology trials across various therapeutic areas.

• Manage the allocation of resources, timelines, budgets, SOPs, policies, Health Care Compliance, and local regulatory requirements.

• Supervise Trial Managers, Site Managers, Clinical Trial Assistants, and other GCO personnel.

• Establish goals and objectives, perform performance evaluations, and promote talent development.

• Anticipate resource needs and work in collaboration with Flex Resource managers on hiring, onboarding, offboarding, and performance feedback.

• Conduct interviews, hire, develop, and train team members.

• Ensure compliance with training requirements for direct reports and their understanding of relevant processes.

• Assist in resolving issues and facilitating communication with Ethics Committees, Health Authorities, Investigational Sites, and study teams.

• Aid in the implementation of organizational changes and communicate shifts in priorities.

• Review and authorize expenses according to company policies.

• Provide coaching and mentorship, including on-site visits when appropriate.

• Define and implement long-term ED&CP organizational strategies.

• Oversee clinical trials from feasibility assessments through to close-out, ensuring readiness for inspections.

• Ensure that operational goals align with ICH-GCP, SOPs, and procedural documents.

• Escalate issues and report any suspected fraud, scientific or ethical misconduct, and breaches of health care compliance.

• Contribute to CAPA and issue resolution processes.

• Build and maintain relationships with ED&CP, GCO, Country Head, Local Operating Company, and other stakeholders.

• Develop country ED&CP capabilities and collaborate on study placements.

• Oversee feasibility assessments and site selection to meet country commitments and strategic objectives.

• Lead reviews of metrics and follow-up actions.

• Ensure quality oversight and readiness for inspections.

• Manage local ED&CP budgets and financial reporting.

• Implement local processes and regulatory requirements for Late Development and Early Development teams.

• Contribute to the establishment of new processes and systems for ED&CP study management.

• Promote continuous improvement, innovation, and a culture based on Credo.

⛳️ Requirements

• Bachelor's degree or equivalent is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).

• A minimum of 8 years of clinical research experience in the pharmaceutical industry, CRO, or investigational site is required.

• Previous clinical trial experience in ED&CP is preferred.

• Demonstrated proficiency in AI literacy and an AI-enabled mindset, including responsible use of AI tools in everyday work.

• Strong communication and leadership skills.

• Ability to foster team productivity and cohesion.

• Experience in mentoring and coaching others; line management experience is desirable.

• Skilled in leading, hiring, training, developing, and assessing personnel.

• Robust decision-making and financial management abilities.

• Effective problem-solving and contingency planning skills.

• Comprehensive knowledge of drug development, clinical research operations, regulatory requirements, ICH-GCP, HCC, and relevant regulations.

• Ability to synthesize and assess data from various reports and sources.

• Effective communication with both internal and external stakeholders.

• Flexible mindset and capacity to work in a fast-paced, rapidly changing environment across different therapeutic areas.

• Ability to operate with minimal supervision.

• Proficiency in English.

• Computer literacy required.

• Strong interpersonal and negotiation skills.

• Excellent organizational capabilities.

• Ability to collaborate effectively and manage multiple priorities within a matrix environment.

• Ability to carry out tasks in a timely and accurate manner.

🏝️ Benefits

• Retirement plan (pension).

• Savings plan (401(k)).

• Vacation – 120 hours per calendar year.

• Sick time – 40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents.

• Holiday pay, including Floating Holidays – 13 days per calendar year.

• Work, Personal, and Family Time – up to 40 hours per calendar year.

• Parental Leave – 480 hours within one year of birth/adoption/foster care of a child.

• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year.

• Caregiver Leave – 80 hours in a 52-week rolling period.

• Volunteer Leave – 32 hours per calendar year.

• Military Spouse Time-Off – 80 hours per calendar year.

• Inclusive interview accommodations.

• Equal opportunity employment.