Pulmovant
Associate Director, Clinical Supply
Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for pulmonary diseases. Pulmovant’s first program, mosliciguat, is an inhaled treatment for pulmonary hypertension (PH).
Position: Associate 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. The role coordinates operations including clinical packaging, labeling, and distribution, managing inventory, logistics, and forecasting for the clinical study. The Associate Director will be the subject matter expert on clinical drug supply throughout the trial lifecycle and lead global clinical inventory management, supply planning, and distribution systems to meet cGMP and corporate objectives. Vendor management, performance metrics, and contractual agreements are also key responsibilities.
Key Duties and Responsibilities
Directly oversee contract manufacturing packaging, labeling, and international shipping/distribution operations for Investigational Medicinal Product (IMP) ensuring on‑time delivery for clinical trials.
Manage, coach, and mentor Clinical Supply Managers, developing a best‑in‑class clinical supply area.
Act as primary liaison with contractor(s) (CMOs). Complete business and performance metrics, negotiate quotes, and write work orders for new trials.
Work with CMC, Clinical Operations, QA, and Regulatory to develop kits and label text for multiple countries/regions and support IND filings as required.
Establish SOPs, protocols, and procedures for clinical trial material packaging, labeling, and distribution to ensure compliance with cGxP requirements.
Manage the development of pharmacy manuals with appropriate internal subject matter experts.
Manage vendor selection for clinical study support, including Clinical Packaging and Labeling facilities. Work with Regulatory Compliance and QA in selection/qualification of CMOs.
Serve as subject matter expert for clinical trial supply during regulatory inspections.
Proactively address risk management issues and implement business continuity plans.
Prepare clinical study supply forecasts as required.
Education and Experience
Minimum of 7 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, and clinical trial designs (randomized, double‑blind, placebo‑controlled).
Thorough knowledge of cGMP, ICH/cGXP guidelines, and global Health Authority requirements.
Proficiency in computer software applicable to IVRS/IWRS, Excel, PowerPoint, and MS Project.
Good organizational, communication, and presentation skills; effective project and time management skills; ability to work under pressure.
Experience with regulatory submissions a plus.
The duties of this role are generally conducted in an office environment. Employees must be able to use a computer, engage in communications via phone, video, and electronic messaging, engage in problem solving and analytical dialogue, collaborate with others, and 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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Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for pulmonary diseases. Pulmovant’s first program, mosliciguat, is an inhaled treatment for pulmonary hypertension (PH).
Position: Associate 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. The role coordinates operations including clinical packaging, labeling, and distribution, managing inventory, logistics, and forecasting for the clinical study. The Associate Director will be the subject matter expert on clinical drug supply throughout the trial lifecycle and lead global clinical inventory management, supply planning, and distribution systems to meet cGMP and corporate objectives. Vendor management, performance metrics, and contractual agreements are also key responsibilities.
Key Duties and Responsibilities
Directly oversee contract manufacturing packaging, labeling, and international shipping/distribution operations for Investigational Medicinal Product (IMP) ensuring on‑time delivery for clinical trials.
Manage, coach, and mentor Clinical Supply Managers, developing a best‑in‑class clinical supply area.
Act as primary liaison with contractor(s) (CMOs). Complete business and performance metrics, negotiate quotes, and write work orders for new trials.
Work with CMC, Clinical Operations, QA, and Regulatory to develop kits and label text for multiple countries/regions and support IND filings as required.
Establish SOPs, protocols, and procedures for clinical trial material packaging, labeling, and distribution to ensure compliance with cGxP requirements.
Manage the development of pharmacy manuals with appropriate internal subject matter experts.
Manage vendor selection for clinical study support, including Clinical Packaging and Labeling facilities. Work with Regulatory Compliance and QA in selection/qualification of CMOs.
Serve as subject matter expert for clinical trial supply during regulatory inspections.
Proactively address risk management issues and implement business continuity plans.
Prepare clinical study supply forecasts as required.
Education and Experience
Minimum of 7 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, and clinical trial designs (randomized, double‑blind, placebo‑controlled).
Thorough knowledge of cGMP, ICH/cGXP guidelines, and global Health Authority requirements.
Proficiency in computer software applicable to IVRS/IWRS, Excel, PowerPoint, and MS Project.
Good organizational, communication, and presentation skills; effective project and time management skills; ability to work under pressure.
Experience with regulatory submissions a plus.
The duties of this role are generally conducted in an office environment. Employees must be able to use a computer, engage in communications via phone, video, and electronic messaging, engage in problem solving and analytical dialogue, collaborate with others, and 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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