Job Description

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.

Summary:

The Director of PV/Drug Safety Operations will provide the strategic and tactical oversight for Pulmovant’s drug safety operations and handle program-level drug safety/PV operational activities. This position will work closely with the existing drug safety team and the head of regulatory affairs and drug safety to ensure all aspects of drug safety operational requirements for novel drug clinical development are managed. The role will require direct management of safety systems oversight, safety infrastructure implementation, safety processes, and program-level drug safety assessment, with a strong understanding of drug safety science. A successful candidate must have significant experience in drug development encompassing early phase 1 to late phase 3 clinical studies and have worked in supporting global programs within a highly cross-functional team structure.

Key Duties and Responsibilities:

• Works with external vendors on safety case processing and systems management.
• Develops and implements, when necessary, drug safety/PV infrastructure and systems.
• Oversees and manages Pulmovant’s safety database system.
• Oversees safety processes and SOPs.
• Works with the existing drug safety team at Pulmovant to ensure all drug safety responsibilities are appropriately handled.
• Works closely with regulatory affairs Vants to ensure all drug safety regulatory reporting requirements are met.
• Responsible for developing and managing any pharmacovigilance agreements with external partners.
• Is able to assess clinical study-specific safety, whether it is at the study design standpoint or at the level of a specific safety case report.
• Handles in-licensing due diligence from a drug safety/PV standpoint.
• Functions as the drug safety/pharmacovigilance subject matter expert on program and diligence teams.
• Keeps up to date on changing regulatory landscape as it applies to drug safety and pharmacovigilance.

Skills, Qualifications and Requirements:

• RN, MS, MPH, PharmD or equivalent degree.
• Minimum 15 years of drug development experience in the pharmaceutical industry.
• Must have experience in phase 1 (early stage) programs through phase 3 (late stage) programs.
• Must have experience in global clinical studies and reporting requirements.
• Strong understanding of PV processes and quality requirements.
• 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, allowing for an open and effective dialogue throughout the company.
• Experience with ArisGlobal LSMV and Veeva Vault systems is preferred.
• Must be able to command respect from peers and capable of highly independent work as well as being a team player and role model.
• Must be a highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
• Proven ability to manage multiple projects.

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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