Associate Director, Clinical Operations

Job Description

Job Description

Why Join Us?

Parabilis Medicines, Inc is a biopharmaceutical company pioneering the discovery and development of Helicon™ peptide therapeutics; these ultra diverse alpha-helical peptides are capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, Parabilis is poised to revolutionize the medical possibilities for patients by precisely drugging intracellular targets long understood to be significant drivers of disease but never before drugged due to the limitations of existing drug modalities to act within the cell. FOG-001, the company's first-in-class TCF-blocking β-catenin inhibitor, is being evaluated in a Phase 1 / 2 study for patients with advanced solid tumors, including desmoid tumors and colorectal cancer. Parabilis is fully leveraging the unprecedented potential Helicons present by deploying proprietary, custom-built machine learning and computational methods as part of its discovery and development process. Parabilis Medicines has raised more than $500 million to date from leading life sciences investors. Parabilis is headquartered in Cambridge, Mass.

What's the opportunity?

In this role, you will help us develop a new drug modality for cancer and other diseases with unmet medical needs by working directly with Research and Development (R&D) functions to execute clinical trials.

The Associate Director, Clinical Operations will provide expertise and oversight for multiple clinical trials or a clinical program to ensure the trials are conducted in accordance with the protocols, SOPs, GCP and departmental and corporate goals. This role will provide strategic leadership and direction to CROs and other vendors. Additionally, this leader will provide Clinical Operations expertise in cross-functional meetings and corporate SOPs and initiatives.

You will work in a nimble, dynamic, matrix environment with Clinical Trial Teams (CTT), investigative site staff and a variety of vendors and consultants to ensure trial delivery in accordance with SOPs, applicable regulations and guidelines. This individual will report directly to the Vice President, Clinical Operations.

• Accountable for delivery of assigned clinical program / trial budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support trial and / or program objectives
• Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan
• Lead and execute all trial phases based on stage of development in compliance with ICH / GCP, local regulations and Parabilis procedures
• Manage and provide oversight to the cross functional team and CRO / vendor(s) related to all aspects of clinical trial operations
• Evaluate, qualify, onboard and train vendors and investigative sites
• Review and provide clinical operations input into regulatory documents such as clinical trial protocols, informed consent forms (ICFs), investigator brochures, and study reports
• Perform and document study level Sponsor Oversight of outsourced clinical activities ensuring a trial storyboard is inspection ready
• Communicate study-status, cost and issues to ensure timely decision-making by senior management
• Oversee / collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
• Maintain oversight and participate in the creation / review / training / maintenance of departmental and organizational SOPs to ensure compliance
• Lead and / or participate in clinical operations workstreams related to departmental and operating model related initiatives
• Provide managerial oversight and mentorship to assigned clinical operations staff by providing clinical operations and functional area expertise and support identification and prioritization of study and program level work
• Conduct site and CRA oversight visits
• Drive trial and site level performance and engagement through regular communication, clear expectation setting, and development of action plans for issue remediation
• Develop and maintain strong relationships, including external partners such as investigators, site staff, collaborators and Key Opinion Leaders
• Program / trial budget management, reporting and forecasting activities
• Maintain current knowledge of external environment to ensure innovations (such as AI / Machine Learning) are considered and / or incorporated into clinical trial delivery strategy

What you'll need to be successful :

Core Values

Parabilis Medicines is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit.

As an equal opportunity employer, Parabilis Medicines values diversity and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

30 Acorn Park Drive | Cambridge, MA 02140 | www.parabilismed.com