Head of Clinical Operations for Oncology Programs

POSITION TITLE: Head of Clinical Operations for Oncology Programs
REPORTS TO: VP, Clinical Operations
POSITION TYPE: Full-time, exempt position

PharmaIN Corporation is a clinical-stage biopharmaceutical enterprise focused on the discovery and development of innovative peptide-based therapies targeting liver diseases and oncology.

We are in search of a dynamic, results-driven, and collaborative leader with extensive global clinical operations and drug development expertise, who is passionate about operational excellence to take on the role of Head of Clinical Operations for our expanding Oncology Programs team.

This role will oversee and mentor Clinical Trial Managers, Clinical Research Associates, and Clinical Trial Assistants.

POSITION SUMMARY:

The Head of Clinical Operations will act as the lead for the oncology program, collaborating closely with Clinical Development Leads, Clinical Trial Managers, cross-functional teams, and study members to plan, implement, and execute complex clinical trials involving new and emerging therapeutics within the PharmaIN oncology portfolio.

You will be responsible for managing the clinical operations of oncology trials and contributing to the development and enhancement of departmental infrastructure. This position encompasses full-cycle trial planning, execution, and reporting, while providing leadership across project teams, study teams, and matrix teams of direct and indirect reports.

KEY ACCOUNTABILITIES:

• Deliver results-driven oversight and hands-on management of the clinical operations team, establishing clear accountability to company leadership.
• Formulate and execute clinical operations strategies for the oncology portfolio, promoting excellence within cross-functional teams.
• Plan, initiate, and execute clinical trials, optimizing trial design, recruitment, and data collection to achieve corporate objectives and timelines.
• Contribute to the development and review of clinical documentation.
• Develop and manage the clinical operations budget, monitoring financial metrics and resource allocation across the oncology portfolio.
• Create and maintain program and study timelines, track milestones, and monitor overall operational performance metrics, communicating updates to key stakeholders and upper management.
• Lead strategies for identifying, assessing, selecting, engaging, managing, and overseeing suitable vendors, CROs, and site investigators. Manage relationships with CROs and vendors, negotiating contracts for quality and efficiency, while analyzing performance trends and addressing issues as necessary.
• Collaborate effectively with other functions such as Pre-Clinical, Clinical Development, CMC, Bioanalytical, Project Management, and Business Development.
• Oversee and support inspection readiness activities that facilitate system reviews, audits, and regulatory inspections related to clinical trial conduct.

DEPARTMENTAL LEADERSHIP

• Contribute to internal initiatives aimed at establishing and enhancing departmental infrastructure, procedures, methods, techniques, and standards for projects, processes, and personnel.
• Champion or participate in departmental initiatives.
• Exhibit strong financial acumen necessary for managing clinical trial budgets.
• Participate in departmental business decisions, infrastructure planning, and implementation.
• Demonstrate a comprehensive understanding of industry trends and challenges, proactively translating them into actionable steps at the clinical operations level.

SUPERVISORY & DEVELOPMENT

• Set clear objectives for oncology clinical operations team members and direct reports. Mentor direct reports on their performance, development, and career aspirations.
• Provide supervision, management, and guidance to Clinical Trial Managers, Clinical Research Associates, and Clinical Trial Assistants, monitoring their performance and deliverables.
• Oversee and provide direction to study teams and their deliverables.
• Ensure that the competencies and skills required for the trial team align with defined requirements and assigned roles.
• Ensure all necessary departmental and project-specific training is provided and current.

The preceding job description outlines the general nature and level of work performed by employees in this classification. Additional and incidental duties related to the primary responsibilities may be required periodically.

Qualifications:
Must possess a strong understanding of clinical drug development processes, clinical study design, study planning and management, and monitoring. Experience in planning, conducting, and managing Phase 1-3 clinical trials, including multinational studies (e.g., Europe, Canada, Asia Pacific preferred).

• Bachelor's degree (or equivalent) in a relevant scientific discipline, with an advanced degree or nursing degree preferred.
• 10+ years of experience in biotech/pharmaceutical clinical trials, with significant experience in liver and/or other complex diseases.
• Minimum of 5 years of experience in people management, including overseeing the work of clinical, contract, and CRO staff.
• Extensive experience in developing RFPs, selecting vendors and CROs, and effectively managing CROs and other trial-related vendors in a results-oriented environment.
• Excellent communication skills (both written and verbal) and strong interpersonal abilities.
• Resilient, creative, and capable problem-solver; able to act swiftly with a sense of urgency and thrive under time-sensitive conditions; driven by a desire to implement innovative approaches and technologies to enhance efficiency and value.
• Comprehensive knowledge of ICH/GCP guidelines and relevant regulatory standards; regulatory inspection experience preferred.
• Previous experience in selecting industry-standard systems, such as trial master file systems, clinical trial management systems, and data management systems (e.g., RAVE).
• Proficient in MS Office Suite, SharePoint, TEAMs software platforms. Capable of creating program timelines in MS Project, SmartSheet, or similar platforms.
• This position may require up to 25% domestic travel and may include limited international travel. A current passport is necessary for international travel.

ESSENTIAL ATTRIBUTES

• Willingness to actively engage and complete tasks to achieve departmental and company objectives.
• Leads by example and learns from experiences.
• Adapts effectively to changing priorities.
• Clearly communicates milestones, risks, mitigations, and essential feedback.
• Comfortable engaging with stakeholders.
• Values colleagues' input and fosters a collaborative team environment.
• Works efficiently without compromising quality.
• Innovates and eliminates redundant, inefficient, and manual processes where feasible.

COMPENSATION:

This position offers a compensation range based on qualifications and experience.

Director range: $180,000 to $230,000 annually
Sr. Director range: $210,000 to $265,000 annually

At PharmaIN, we implement equitable workplace strategies to ensure fair compensation. Actual compensation packages are determined by various factors, including skill set, experience, certifications, and location, in addition to internal equity and alignment with current market data. We prioritize the well-being of our employees and provide generous benefit plans, flexible paid time off, and competitive pay. Our goal is to foster an environment where all employees can thrive.

The PharmaIN Team is dedicated to meaningful work and committed to addressing complex challenges in liver diseases and oncology to develop new therapies for patients. We value innovative thinking, collaboration, flexibility, action, and healthy debate.

PharmaIN is committed to fostering a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. PharmaIN is also committed to compliance with all fair employment practices regarding citizenship and immigration status.