Head of Clinical Operations, Pulmovant

Pulmovant

About The Position

The Head of Clinical Operations will be responsible for establishing the clinical operations function for an incubating portfolio company (Vant) focused on development of first- and best- in class treatments in pulmonary diseases. S/he will lead and oversee execution of clinical program to progress programs forward within the portfolio. S/he will proactively identify and mitigate risks, lead from the front and collaborate with the Head of Clinical Development and SVP, Clinical Operations to improve timelines, ensure operational planning and execution excellences, and budgeting for the clinical program. This is an opportunity to play an instrumental role in bringing a novel therapy to market with blockbuster commercial potential while providing better treatment options for patients living with pulmonary diseases.

Requirements

Bachelor's Degree in a scientific discipline; with a minimum of 12-15 years clinical development experience.
Extensive clinical operations management experience, including program leadership or TA leadership at a minimum
Proven excellence in clinical operations strategy and execution, including Ph I-IV studies, global clinical trial operations, and multiple clinical trials simultaneously. Experience in Respiratory/Pulmonary diseases preferred
Hands-on, detail-oriented leader with operational fluency
Demonstrated ability to set and prioritize goals and objectives, excellent time management, negotiation, problem-solving and organizational skills
Experience in building infrastructure (including SOPs) required
Ability to work independently and collaboratively in a fast-paced, matrixed team environment consisting of internal and external team members
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Strong leadership skills with ability to innovate and collaborate with a small team to articulate clear clinical strategy. Strong coaching and mentoring skills leading to the success and development of subordinates
Willingness to work across all levels to support Clinical Operations success
Strong communication and presentation skills
Willingness/ability to travel (domestic and international)

Responsibilities

Responsible for clinical operations strategy, initiation, and execution of clinical trials, including (but not limited to) CRO/vendor selection, contracts & budgets, CRO/vendor oversight, and proactive risk management to ensure the quality conduct of trials with a high level of quality and data integrity
Responsible for the successful planning and execution of Phase 2 and 3 trials
Proactively builds and strengthens site and Investigator relationships and actively cultivates site engagement
Work cross functionally to drive strategy, oversee the implementation of all clinical programs, and manage the integrated development plans to deliver against company goals
Proactively identify potential risks and develop and implement actions and plans to avoid or mitigate program risks and make appropriate plan to balance risks, deliverables, and costs
Lead and supervise all aspects of study progress from concept to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with regulatory guidelines; heavy emphasis on late-stage development experience
Develops and optimizes critical SOPs needed for program success, inspection readiness and compliance
Oversee identification, qualification, and selection of CROs and vendors needed to conduct clinical trials including approval of Master Services Agreements and Task Orders with CRO
Liaise with KOLs, Investigators, and clinical site staff to ensure optimal Sponsor-Site relationships
Provide scientific/clinical expertise in the design and interpretation of clinical studies
Ensure effective project or program communications and updates to internal and external stakeholders through meetings, presentations, and other methods
Provide direct line management and training/mentoring of Clinical Operations team members
Ensure clinical operation team are trained in regulatory inspection process and develop a pro-active approach for inspection readiness
Align skills and resources needed for program success; work closely with internal and external stakeholders to leverage and optimize resources
Create and oversee clinical program budget(s) and long-range clinical planning/forecasting activities
Ensure there is proper oversight of identified safety concerns and/or adverse events; develop and implement corrective actions accordingly, and participate in internal/external study related audits, as needed
Contribute as required to the authoring of key regulatory documents, study protocols, investigator’s brochures, IND reports, study postings, ensuring document and operating standards are established and maintained
Participate in business development and process improvement/quality initiatives, as needed