Vice President Clinical Operations
Location: South 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: Vice President Clinical Operations
The Vice President, Clinical Operations will have responsibility for the strategic planning and management of the department of Clinical Operations in alignment with corporate goals. With an operations vision to support research and development projects, the individual will manage the Clinical Operations staff responsible for the planning, execution and reporting of clinical trials (Phases I-IV) in support of regulatory submissions with a focus on high quality organization, execution and deliverables. This person interacts with various groups within the company and externally to oversee clinical trial management activities.
The individual in this position is responsible for the organization, planning and management of staff and study oversight. They will also be responsible for planning the growth and integration of the function into an evolving and maturing organization.
The Vice President Clinical Operations will assist in the development of Blade Therapeutics’ pipeline by thorough assessments of candidates, mentoring, training, innovative thinking and active search of opportunities.
The Vice President of Clinical Operations will report to the Chief Medical Officer.
- Provide leadership, strategic planning, effective management and guidance of Clinical Operations.
- Ensure regulatory compliance and adherence to GCP standards.
- Develop a strong Clinical Operations group, coach and mentor subordinates and ensure conflicts are resolved quickly. Provide clear, motivating and constructive feedback.
- Oversees the selection and management of clinical outsourcing.
- Collaborate with functional heads to assure integration of company, project and functional goals towards achieving project milestones and timelines.
- Set strategy for the effective management and resourcing of future clinical trials.
- Develop, track and administer departmental budget, FTE requirements and schedules with responsibility for cost, time and quality of activities. Must be able to anticipate deviations and inform management with proposed corrective actions.
- Liaise with other functional heads to assure timely and effective implementation of clinical studies.
- 10 – 15 years of operations and research management experience in the pharmaceutical or biotechnology industry.
- Expert knowledge of cGCP, ICH and other relevant clinical development and FDA regulations and processes.
- Must have demonstrated track record of effective management /leadership and building a clinical team.
- Effective communication, organizational, interpersonal and leadership skills.
- Ability to operationalize efficient processes.
- Ability to anticipate and identify core problems, apply insightful analyses and solve problems effectively.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment.
- Have strong organizational skills and the flexibility to react rapidly to changing situations.
- Ability to develop and maintain systems and processes in order to complete studies and projects in a timely manner, within budget, and of the quality to meet business goals.
- Build consensus when possible yet able to make difficult decisions when a consensus cannot be developed or know when to escalate issues.
- Ability to work effectively on a team in an entrepreneurial environment.
- Computer skill should include proficiency with Microsoft Office suite of software.
- Ability to function independently using remote office skills and tools.
- Strategic thinker and problem-solver capable of identifying risks and risk mitigation strategies.
- Strong teamwork, negotiation and influencing skills, able to work in a team setting and establish clear and consistent goals and objectives.
- Excellent verbal and written communication skills.
- Strong scientific writer and oral presenter.
- “Out of the box” thinker, to take on calculated risks, and champion new ideas and approaches for the advancement of a product portfolio.
- Up to 20% travel may be required.
- Clinical/healthcare scientific degree (advanced degree preferred)
An attractive compensation package commensurate with this senior leadership role will be provided.