Senior Manager, Program Management, PH-ILD, Pulmovant

Posted 18 Days Ago
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Hiring Remotely in US
Remote
Senior level
Software • Biotech
The Role
Manage supporting PH-ILD drug development studies, including Phase 1, biomarker, population PK, and nonclinical programs. Lead integrated planning, timelines, budgets, risks, issues, documentation, metrics, and stakeholder communication across internal teams and external partners. Coordinate cross-functional development activities and support program management processes, reporting, and governance while ensuring deliverables meet quality and regulatory expectations.
Summary Generated by Built In

Pulmovant is a Roivant-backed clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases. Pulmovant’s first investigational candidate, mosliciguat, is designed to provide a novel, once-daily, inhaled treatment option for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Mosliciguat is a potential first-in-class soluble guanylate cyclase activator with a differentiated mechanism of action currently being evaluated in the Phase 3 PHrontier global clinical trial in PH-ILD, but with potential broad applicability across the PH and ILD disease landscape. 

Pulmovant recently announced positive results from its Phase 2 PHocus study evaluating mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), a progressive and life-threatening condition with significant unmet medical needs for patients. PHocus met both primary and secondary endpoints including the highest ever reported pulmonary vascular resistance (PVR) reduction in any randomized controlled PH trial. The robust results, in conjunction with mosliciguat’s once-daily, inhaled administration and potential first-in-class sGC activator profile, strongly position it as a potential single agent treatment and combination therapy for patients with PH-ILD.  These data represent a significant advancement in a devastating disease that affects ~200,000 patients with no or very limited treatment options. A Phase 3 trial is currently underway. More details can be found in the press release here.

As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress.

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

About Roivant:

Roivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes LISRAYA™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. For more information, visit www.roivant.com.

Position: Senior Manager, Program Management

Summary: 

Pulmovant is seeking a knowledgeable, cross-functional drug development program manager with strong communication skills who thrives in a high-energy, entrepreneurial environment to join our expanding Program Management team. Reporting to the Director, Program Management, this individual will support management of development programs, with a current focus on the supporting studies within the PH-ILD program for mosliciguat (e.g., Phase 1, biomarker, population PK, and nonclinical studies), complementing the Phase 3 PHrontier trial in pulmonary hypertension associated with interstitial lung disease (PH-ILD). This person will serve as a trusted point of contact for program communication between key functional teams, including internal and external stakeholders, core program teams, and senior leadership. The Program Manager will maintain timelines to ensure program deliverables are met on time and within budget. This is a highly visible and critical role that offers the opportunity to make significant contributions to Pulmovant’s research and development programs.

Key Duties and Responsibilities 

  • Lead and manage these supporting PH-ILD studies effectively to ensure they are delivered on time, on budget, and to agreed quality standards by generating high-quality, integrated project plans.
  • Resolve issues and risks within specific assigned studies by working with team members, program stakeholders, and others as appropriate, including escalating to appropriate forums where necessary
  • Maintain direct interaction with cross functional team representatives, as well program management team members at Pulmovant and with external partners.
  • Help establish and integrate key program management tools, processes, initiatives, and documentation to ensure efficient cross-functional program planning, execution, and monitoring (metrics), and to ensure efficient tracking and reporting.
  • Own day-to-day program management for the supporting studies within the PH-ILD program (Phase 1, biomarker, population PK, and nonclinical), partnering with the Director, Program Management, who retains direct ownership of the overall PH-ILD development program.
  • Manage standards, procedures, and practices of record-keeping for meetings and communications (agendas, minutes, charters, dashboards, reports)
  • Communicate effectively and manage time to meet the expectations of all stakeholders.

Education and Experience 

  • BS/BA degree in the health sciences required, with a demonstrated track record of success.
  • 8 years experience in pharmaceutical drug development, with 5 years experience directly managing and/or leading cross functional drug development teams.
  • Drug development knowledge with frequent exposure to other functions and cross functional teams, including but not limited to Research, Pre-Clinical, Clinical, Manufacturing and Operations, Commercial, Regulatory, Safety, and Payer.
  • Understanding of Good Manufacturing Practices and Product Development Process requirements.
  • PMP certification a plus (including in progress).

Essential Skills and Abilities 

  • Demonstrated skills in collaborating and influencing cross-functionally.
  • Strong organizational and interpersonal skills.
  • Strong planning and execution skills; experience using MS Project, Smartsheet or equivalent is required.
  • Strong written and oral communication skills.
  • Critical thinking and problem-solving skills.
  • Demonstrated competencies in all aspects of project management.
  • Proficiency with project management tools and analytics.
  • Knowledge of applicable quality and regulatory standards requirements for the pharmaceutical industry.

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.

We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!

Skills Required

  • BS or BA degree in health sciences
  • 8 years of experience in pharmaceutical drug development
  • 5 years of experience directly managing or leading cross-functional drug development teams
  • Knowledge of drug development and exposure to Research, Pre-Clinical, Clinical, Manufacturing and Operations, Commercial, Regulatory, Safety, and Payer functions
  • Understanding of Good Manufacturing Practices and product development process requirements
  • Cross-functional collaboration and influencing skills
  • Strong organizational and interpersonal skills
  • Strong planning and execution skills
  • Experience using MS Project, Smartsheet, or equivalent
  • Strong written and oral communication skills
  • Critical thinking and problem-solving skills
  • Competency in project management
  • Proficiency with project management tools and analytics
  • Knowledge of applicable pharmaceutical quality and regulatory standards
  • PMP certification
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The Company
HQ: Waltham, Massachusetts
48 Employees

What We Do

Pulmovant is a clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases and is a Roivant (Nasdaq: ROIV) company. Pulmovant’s first investigational candidate, mosliciguat, is designed to provide a novel, once-daily, inhaled treatment option for patients with pulmonary hypertension associated with Interstitial Lung Disease (PH-ILD). Mosliciguat is a potential first-in-class soluble guanylate cyclase activator with a differentiated mechanism of action currently being evaluated in PH-ILD.

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