Senior Director, Clinical Operations, Pulmovant

Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. Pulmovant’s first program, mosliciguat is designed to provide an effective, once-daily, inhaled treatment option for patients with pulmonary hypertension (PH). Mosliciguat is a novel, potential first-in-class, sGC activator with a differentiated mechanism that may have broad applicability across the PH spectrum.

Mosliciguat has been extensively characterized across a robust Phase 1 program with 170 participants dosed to date including patients with PH in the Phase 1b ATMOS study which has produced highly compelling and clinically meaningful efficacy data, as well as a favorable safety profile. Enrollment in a phase 2 trial will begin this year.

As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress. Roivant specializes in developing transformative medicines at an accelerated pace through the launch of nimble biopharmaceutical and health technology entities, each meticulously tailored to address a specific medical need.

For more information, please visit https://www.pulmovant.com. 

Summary:  

The candidate will have responsibility for the oversight, planning and execution of Pulmovant’s lead clinical program.  This is a visible leadership role in the company reporting to the Senior Vice President, Clinical Operations and requires an energetic and resourceful individual with excellent operational skills, written and verbal communication skills and demonstrable technical/medical/scientific aptitude and problem-solving skills.  In addition to the responsibilities below, this individual will serve as an advocate/spokesperson of the program both within and outside of Pulmovant, working with program stakeholders to advance the program’s activities through product approval.  This person will contribute significantly to the strategic direction of Pulmovant’s clinical program(s).

Key Duties and Responsibilities 

• Responsible for clinical operations strategy, initiation, and execution of clinical trials, including (but not limited to) CRO selection, contracts & budgets, CRO/vendor oversight, and proactive risk management to ensure the quality conduct of trials with a high level of data integrity;
• Lead and supervise all aspects of study progress from concept to close-out to assure adherence to intended timelines and achievement of study and corporate goals while ensuring quality in accordance with regulatory guidelines;
• Manage project planning, budget, and resource deployment for clinical studies and for other developmental needs, as requested;
• Collaborate in design and implementation of clinical protocols, clinical data collection, and quality management; 
• Collaborate on, author, and review of clinical documents (e.g., Investigator Brochures, IND annual updates, safety reports, protocols, clinical study reports, informed consents, etc.);
• Ensure effective project or program communications and updates to internal and external stakeholders through meetings, presentations, and other methods;
• Participate as an integral member of development team to provide clinical operational input in overall product development planning;
• Participate in decisions on data analysis and data presentation in order to fulfill corporate needs;
• Provide direct line management and training/mentoring of Clinical Operations team members; 
• Align skills and resources needed for program success; work closely with internal and external stakeholders to leverage and optimize resources;
• 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; 
• Participate in business development and process improvement/quality initiatives, as needed;
• Travel to field sites to supervise and coordinate clinical studies.

Education and Experience 

• S/B.A. in a scientific or health-related field;
• 15+ years in all aspects of clinical trial management involving the establishment, planning, operation, and successful and timely completion, including 9+ years clinical study/program management;
• Experience in setup, execution and operational management of domestic and international Phase 1, 2, and 3 clinical trials across an array of therapeutic areas;
• Thorough knowledge of US and EU regulations and global study management. 
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders, including external vendors, contractors and strategic partners
• Excellent verbal and written skills, allows for an open and effective dialogue throughout the company.
• Demonstrated scientific aptitude and problem-solving skills;

• Strong project management skills and a general understanding of drug development “beyond the clinical sphere;
• Strong communication and presentation skills and a desire to contribute broadly within a start-up environment.  
• In addition to above, this person needs to have the following attributes: high energy, creative, diplomatic, persuasive, decisive and collaborative.  This person must possess a desire and ability to make things happen;
• Strong entrepreneurial spirit and ability to function in a small, energetic start-up environment.

 Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. 

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