We are looking for a Director/Senior Director of Clinical Operations to lead one or more of AsherBio’s clinical programs to ensure completion per established corporate goals and objectives. The Director/Senior Director of Clinical Operations will report to the Chief Medical Officer and will work closely with a cross-functional team in a fast-paced high growth environment to ensure that clinical trials are conducted on time and within budget, and in accordance with applicable GCP/ICH guidelines and other regulatory requirements.

Responsibilities 

• Provide leadership, oversight, and line management for early-stage oncology program to ensure clinical trials are conducted in accordance with the protocols, timelines, and budgets
• Develop, implement, and provide oversight of study and program budgets, including CRO/vendor budgets and contracts, with a planning horizon of 12-24 months
• Lead the team in the selection of Contract Research Organizations (CROs) and vendors 
• Effectively communicate expectations to CROs and serve as key escalation point for the study teams
• Oversee scope, quality, timelines, and budget, working with internal functional leads, CROs, and other vendors to ensure overall project objectives are met
• DJ
  Member of the Core Team, providing strategic operational input to efficiently meet corporate objectives 
• Present to the Executive Leadership Team on trial progress, budget development and forecasting, and changes in scope 
• Identify and mitigate risks to study implementation, enrollment, conduct, compliance, budget, and completion 
• Develop and manage effective working relationships with Investigators and other key clinical opinion leaders 
• Contribute to the development of clinical documents (protocols, ICFs, Investigator Brochure, monitoring plans, cohort management plan, pharmacy manual, etc.)
• Contribute to the establishment of clinical operations SOPs, Work Instructions, guidelines, standards, and best practices 
• Participate as a functional contributor to due diligence/business development evaluations including the review of external clinical development plan (CDP) and strategy, the development of internal timelines, budget estimations and resources needed to support the CDP
• Ensure compliance with all applicable regulatory requirements, including FDA regulations, ICH guidelines, and GCP standards.

Qualifications 

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required. 

• Bachelor’s degree required
• 15 years industry experience, including 8 years managing trials with CROs 
• Strong leadership skills with ability to be hands-on to fill gaps as needed and lead/manage the clinical operations team 
• Experience with direct line-management of clinical operations staff
• Has demonstrated success identifying, negotiating and overseeing outsourced clinical operations services and vendors 
• Experience with financial forecasting, budgeting and reporting 
• Experience in early phase clinical trials in oncology is strongly preferred
• Able to set priorities, juggle multiple demands, and manage changing priorities 
• Has a thorough knowledge of the clinical trial development process and Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States and abroad
• Strong communication (verbal, written, listening) and interpersonal skills with the ability to communicate effectively with investigators, vendors, and individuals across different levels of the organization, including executive leadership team 
• Travel may be required up to 10% in both the U.S. and abroad