Director, Clinical Supply, Pulmovant

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. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 Vants; 12 consecutive positive Phase 3 trials; 9 FDA approvals; 5 successful IPOs; >$6B in capital raised; >$10B in global pharma partnerships and proceeds; and continued pipeline expansion across various modalities and therapeutic areas through in-licensing and acquisition of novel product candidates and technology platforms. In addition to a robust clinical stage pipeline, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business.

Position: Director, Clinical Supply

Pulmovant is seeking a leader in Clinical Supply who will provide planning and execution of Clinical Supply Chain activities to support Pulmovant clinical studies globally. This position coordinates operations including clinical packaging, labeling, and distribution. Responsible for actively managing all inventory, logistics and forecasting for the clinical program. This person will be the subject matter expert related to clinical drug supply during all phases of the clinical trial and will support activities leading to the implementation of global clinical inventory management, supply planning and distribution systems consistent with meeting cGMP, clinical development programs, corporate objectives and is responsible for vendor management including performance metrics.

Key Duties and Responsibilities

Directly oversee contract manufacturing packaging, labeling, and international shipping/distribution operations for IMP (Investigational Medicinal Product) ensuring on time delivery to support clinical trials

Manage, coach and mentor Clinical Supply Managers

Act as primary liaison with contractor(s) (CMO's). Complete business and performance metrics

Work with CMC, Clinical Operations, QA and Regulatory to develop kits and label text for multiple countries/regions and provide support for IND filings as required

Establish SOPs, protocols, and procedures for clinical trial material packaging, labeling and distribution to ensure compliance with cGxP requirements

Manage development of pharmacy manuals with appropriate internal subject matter experts

Manage vendor selection for clinical study support, including Clinical Packaging and Labeling facilities as required. Work with Regulatory Compliance and QA in selection/qualification of CMO's

Subject matter expert for clinical trial supply during regulatory inspections

Proactively address risk management issues and implement business continuity plans

Minimum of 8 years of related experience in the pharmaceutical industry with at least 5 years of direct experience in Global Clinical Supply Management

Prior investigational drug product experience and prior GCP training is required

Recent industry experience with clinical supplies or clinical operations is preferred

Essential Skills and Abilities

Ability to communicate and maintain collaborative relationships effectively with key internal and external stakeholders

Proven ability to select, secure and manage external vendors to achieve results and control expenditures

Demonstrated experience with global clinical supply forecasting, planning, packaging, labeling, inventory management, IVRS systems, clinical trial designs (randomized, double, blind, placebo controlled)

Thorough knowledge and understanding of cGMP, ICH/cGXP guidelines and global Health Authority requirements

Proficiency in computer software applicable to IVRS/IWRS, Excel, Power point and MS Project

Good organizational, communication and presentation skills, effective project and time management skills and the ability to work under pressure

Experience with regulatory submissions a plus

The duties of this role are generally conducted in a remote environment. As is typical of a remote-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours

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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