Spirovant is a gene therapy leader focused on changing the course of cystic fibrosis and other respiratory diseases. Our gene therapy technologies are using adeno-associated virus (AAV) and lentivirus vectors designed to overcome the historical barriers that have prevented effective genetic treatments for lung conditions such as cystic fibrosis. We are a rapidly growing company located in the biotech heart of University City, Philadelphia.
To support our continued expansion and enable our future success, the newly created role of Head of Clinical Operations, will lead global clinical operations effort as the company approaches the clinical development stage for its lead product. The role reports to the CMO and will be responsible for planning and executing clinical trials in the US, Europe and other countries worldwide, within time and cost constraints, ultimately resulting in high quality clinical trial data on all Spirovant investigational products and marketed medicines.
S/he will influence decision making and strategy for the Company, requiring expertise in compliance, assessment, and leadership spanning the support of existing and potential partnerships.
The ideal candidate will be a strong, collaborative leader who brings a tactile and strategic approach to projects spanning the clinical development process.
- Hire, lead, and manage a team of highly experienced clinical operations professionals, both internal employees and external consultants
- Deliver consistently high-quality results that are on time and within budget guidelines for all Spirovant clinical studies, across the product lifecycle (phase 1 through phase 4)
- Oversee cross-functional authorship of key study related documents: protocol concept sheets, protocol synopses, protocols, informed consent forms, case report forms, study governance committee charters (e.g., data monitoring committee) and clinical study reports
- Accountable for both in-house and outsourced data management and clinical study drug management (forecasting, labeling, packaging, and distribution activities)
- Accountable for vendor management
- Ensure requests for proposals (RFPs) meet user requirements, and all contracts (i.e., study sites, vendors) are efficiently executed with key performance indicators
- Partner with finance team to accurately estimate trial costs to enable the long-range planning process, and ensure teams accurately accrue costs throughout duration of clinical trials
- Lead all vendor governance committees
- Responsible for the creation and maintenance of clinical trial recruitment dashboards to enable real-time understanding of progress and issue identification; proactively propose solutions to achieve goals
- Own the creation and maintenance of all clinical trial related systems, standard operating procedures (SOPs), and policies
- Responsible for achieving annual departmental budget goals
- Possesses an understanding of and experience in leading early stage clinical development programs in rare disease
- Create, manage, and execute clinical operations and development programs, including study management, budget and timeline creation.
- Build strong KOL and Investigator relationships with the capability of understanding and explaining complex scientific topics
- Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
- Help to author clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary
- Develop and ensure execution of activities outlined in various study plans (data management, safety management, and study communication plans)
- Participate in preparation of regulatory filings (e.g. IND, pre-IND, orphan applications etc.) as needed
- Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with GCP and ICH guidelines
- Manages and develops clinical operations quality systems, including standard operating procedures, document management, clinical operations personnel training, and quality control processes
- Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed
- Spirovant, the successful candidate will be an established Clinical Operations leader who thrives in a fast paced, collaborative environment with a strong track record of hands-on experience in Clinical Trial planning and execution. The successful candidate will also be a highly creative leader and problem solver, who thrives in a “get it done” type of environment.
- A minimum of 10 years of experience in both industry and academia with thorough understanding of clinical trial processes including clinical supply, data management, biostatistics, and medical writing
- Advanced degree in scientific field such as PhD, PharmD, MS preferred
- Domain expertise in rare disease drug development is required
- Experience with inhaled drug development in CF or respiratory indications, drug-device combination development and gene or cell therapy is preferred.
- Known to be a clinical operations expert, with a prior track record of innovative trial execution that utilizes the latest technologies to ease site and study participant burden, decrease cost, maintain data integrity plus participant retention and achieve health authority requirements
- Excellent written and verbal communication skills
- Well established career path including having built a clinical operations department and collaborated extensively with other functional departments: research, clinical research, regulatory affairs, medical affairs
- A seasoned leader, manager and mentor of FTEs and consultants
- Successful experience in at least one fast-paced entrepreneurial biotechnology environment
- Strong working knowledge in Good Clinical Practices and ICH Guideline and the application to the conduct of clinical trials
- Strong analytical and strategic planning skills
- Proven ability to provide scientific and clinical expertise to a clinical development program
- Strong leadership skills; communicates and demonstrates vision and commitment
- Demonstrates effective influence and relationship management skills
- Must display strong analytical, problem solving skills and attention to detail
- Self-starter, independent and a practical thinker
Spirovant is committed to fostering a diverse, inclusive environment and is proud to be an equal opportunity employer.