Associate Director/Director, Clinical Operations
Location: San Francisco, CA
Blade Therapeutics is advancing novel anti-fibrotic therapies to meet important patient needs in an area that has seen little innovation to date. Several rare/orphan and chronic debilitating conditions manifest as a consequence of fibrosis, a complex, pathologic process in which progressive scarring replaces functional tissue. We are seeking to develop therapies to modify disease progression, and in some cases, potentially reverse the fibrotic damage to tissue.
Blade is advancing a risk-diversified product portfolio to address various fibrotic diseases and their underlying pathophysiology. The Company has assembled a critical mass of fibrosis expertise and a top-tier leadership team and world-class network of advisors with unparalleled experience in anti-fibrotic drug R&D. Blade’s founding programs are based on the discoveries of Hal Dietz, M.D., Victor A. McKusick Professor of Genetics and Medicine, Johns Hopkins University, whose pioneering research has elucidated a biological pathway that is enabling the discovery of small molecules to treat and potentially reverse fibrosis.
Blade’s objective is to be the leading anti-fibrotic company with a pipeline of novel therapies designed to address the unmet needs for innovative treatments to treat various fibrotic conditions.
Role: Associate Director/Director, Clinical Operations
The individual in this position is responsible for the management of the Clinical Operations function in alignment with Blade’s corporate goals and the needs of the Development group. With a focus on managerial efficiency and high-quality deliverables, this person will oversee all operational aspects of one or more clinical programs including project timelines, budgets, resource allocation, and management of contract research organizations (CROs) and other key vendors.
The AD/Director will be responsible for execution of clinical studies in full compliance with company SOPs, good clinical practices, and applicable regulatory guidelines. The incumbent will take primary responsibility for coordinating with the VP of Clinical Development and other internal stakeholders to ensure appropriate fiscal oversight, including management of vendor scope-of-work and change orders. In addition, the incumbent will oversee internal and external clinical trials staff and manage all aspects of study operations, including possible line management duties, and will ensure comprehensive, appropriate escalation of issues to the VP. The incumbent will be expected to assist in creating a positive, collaborative team environment with an eye toward innovation and operational excellence.
- Provide leadership, strategic planning, and effective management of the Clinical Operations function
- Ensure regulatory compliance and adherence to GCP standards
- Coach and mentor subordinates and ensure conflicts are resolved quickly; provide clear, motivating and constructive feedback
- Facilitate and participate in the selection and management of clinical outsourcing vendors
- Collaborate with functional heads to assure integration of company, project and functional goals, towards achieving project milestones on schedule and within budget
- Provide strategic input on the management and resourcing of future clinical trials
- Assist in the development and tracking of project finances and staffing with direct responsibility for adherence to project timelines and budgets; must be able to anticipate deviations and inform management with proposed mitigation strategies
- Develop and exhibit facility with data management software as required to review clinical data and associated metrics, and address data quality issues directly with CROs and sites as needed
- Assist with national regulatory and IRB/Ethics Committee submissions and responses to questions as required
- Review and contribute to Clinical Study Reports, INDs, NDAs, and other clinical and regulatory documents
- Represent the company as needed at professional meetings, and present clinical operations materials and provide training at such events as needed
- Provide ongoing assessment and feedback on departmental policies and procedures toward increased efficiency and quality of deliverables; may contribute to the development of SOPs and other procedural documents
- Develop metrics and reports as needed in conjunction with vendors, other clinical operations personnel, and Blade functional leads; summarize and present these data as required
- Assist in clinical compliance activities and facilitate responses to auditors and satisfactory resolution of clinical quality issues
- Travel approximately 20%-50%, depending on departmental needs
Desired Professional Experience
- Expert knowledge of cGCP, ICH Guidelines, and other relevant regulations and processes
- Demonstrated track record of effective management /leadership
- Effective communication, organizational, interpersonal, and leadership skills.
- Ability to anticipate and identify issues, apply insightful analyses, and solve problems effectively
- Ability to handle multiple tasks to meet deadlines in a dynamic business environment, with minimal supervision
- Ability to understand, adapt, and implement best-practice systems and strategies for managing clinical operations and project management tasks to support goals of the development group and of the company
- Ability to work effectively on a team in an entrepreneurial environment
- Clinical experience/background (e.g. RN, PA, or medical office) a plus
- Computer skills should include proficiency with Microsoft Office and ability to use remote office skills and tools to collaborate with off-site collaborators
- Ability and willingness to work with collaborators outside the US, possibly including regular conference calls early in the day or late in the afternoon
- Minimum of 8 years of clinical operations experience, 5 of which must be trial manager level or above, at a CRO or pharmaceutical/biotech company
- BA/BS degree, preferably in the life sciences or related field
- Equivalent combination of education and experience will be considered.
- An attractive compensation package commensurate with experience will be provided.
Interested applicants, please send resume to: Marianne Eid
Blade Therapeutics Is An Equal Opportunity Employer