Associate Director, Clinical Operations
Location
Cambridge, MA | United States
Job description
Why join us?
FogPharma is a clinical-stage biopharmaceutical company that seamlessly integrates breakthroughs in bench science and data science to create transformative precision therapeutics for patients suffering from devastating and often fatal diseases such as cancer. FogPharma's discovery engine creates Helicon™ therapeutics, which are a new generation of ultra-diverse, highly tunable peptide drugs capable of modulating virtually any protein implicated in disease. Our robust and wholly owned pipeline of programs is currently focused on cancer targets that are intractable to small molecules and biotherapeutics.
The company's lead program, FOG-001, is a long sought-after blocker of β-catenin:TCF interactions that is currently being evaluated in a Phase 1/2 clinical trial in patients with Wnt/β-catenin signaling pathway-activated solid tumors, including colorectal cancer. FogPharma has raised more than $350 million to date from top investors and is led by an experienced team of industry experts. FogPharma is headquartered in Cambridge, MA.
What's the opportunity?
Reporting directly to the Sr. Director Clinical, Operations, 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 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.
Responsibilities include but are not limited to:
- 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 (including first in human) based on stage of development in compliance with ICH/GCP, local regulations and Fog procedures
- Manage and provide oversight to the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations
- Evaluate 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
- 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 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 are considered and/or incorporated into clinical trial delivery strategy
What you'll need to be successful: - B.S./B.A. in life science or related field
- 12+ years of clinical operations experience
- Experience in biotechnology, pharmaceutical and/or CRO industry
- Phase 1-3 global trial management experience, including first in human studies, preferably in Oncology
- Direct experience overseeing global CROs in both fully and partially outsourced models
- 3+ years of on-site monitoring experience preferred
- Direct line management experience
- Ability to guide study teams and to coordinate across multiple disciplines to achieve study goals and timelines
- Ability to motivate and inspire teams
- Awareness of drug supply chain
- Ability to work on complex or multiple projects and exercise critical thinking with minimal supervision
- Solid attention to detail and excellent organizational skills
- Strong interpersonal and communication skills (both written and oral)
- Supportive team member with a willingness and ability to fill functional gaps in a small but growing organization
Core Values FogPharma 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.
- Creative . We are creating a whole new class of medicine requiring creativity to solve challenges as they arise, which we have successfully done since the inception of the company.
- Patient-focused. We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.
- Execution-oriented. As we begin clinical development and large-scale manufacturing, the team is balancing creativity and nimbleness with relentless, rigorous and flawless execution.
- Humble . We fully appreciate that science and technology and policy are in flux, and we balance deep experience with humility to ask fundamental questions and seek newly available solutions.
As an equal opportunity employer, Fog 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 |
Job tags
Salary
