Senior Director, Clinical Development, Pulmovant

OpenKrill; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Pulmovant is seeking a highly motivated hands-on physician leader who will be responsible for the design and execution of clinical trial activities to support mosliciguat development, including study design, protocol development, execution and data interpretation. The candidate will be the primary source of medical accountability and oversight for clinical trials and will serve as a medical lead.

The role includes leading the Phase 3 trial and may include indication lead activities for

Qualifications

• MD/DO degree is required.
• Board Certification or Board Eligibility in internal medicine with subspecialty training or experience in drug development in cardiopulmonary/respiratory medicine is desirable.
• Minimum 5–7 years of experience conducting clinical research trials in biopharmaceutical industry, ideally late phase.
• Hands-on experience in protocol development and clinical trial monitoring.
• Experience with US and European Health Authority interactions and submission of regulatory documents is desirable.
• Strong written and verbal communication skills; ability to lead cross-functional teams.

Responsibilities

• Provide clinical leadership for Phase 3 trial design and execution.
• Medical accountability and oversight for trials; liaise between investigators and internal study team.
• Prepare and contribute to regulatory documents, safety reports, and study reports.
• Present at investigator meetings and liaise with Health Authorities.
• Mentor internal and external colleagues and collaborate across functions.

Skills

Clinical trial leadership

Protocol development

Regulatory submissions

Cross-functional collaboration

Medical oversight

Health Authority interactions

Education

MD/DO

Job description

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 Director, Clinical Development

Position Summary:

Pulmovant is seeking a highly motivated hands-on physician leader who will be responsible for the design and execution of clinical trial activities to support the development of mosliciguat, including study design, protocol development, execution and data interpretation. The candidate will be the primary source of medical accountability and oversight for clinical trials and will serve as a medical lead. The candidate will liaise between investigators and the internal study team and will maintain established relationships with key opinion leaders as well as Health Authorities. Scope of responsibility will include a leading role on the execution of the Phase 3 trial and may also include indication lead activities for additional indications as the program is further developed.

KeyDuties and Responsibilities

• Provide clinical and scientific input to study design, protocol concepts and development, statistical analysis plans and reporting to drive high value clinical data.
• Medical strategic oversight and accountability for the formulation of study designs, protocol development, and regulatory documents in collaboration with cross-functional team.
• Provide clinical leadership of trial execution and management of clinical studies with a focus on the phase 3 trial. Provide clinical leadership in the conduct of clinical activities including executional delivery of the study, recruitment, site activation, data review analysis, and reporting that conforms to the highest ethical, safety and quality standards and in compliance with GCP and regulatory standards.
• Remain current on the therapeutic landscape, including regulatory in the relevant therapeutic areas through review of the scientific literature, interactions with key opinion leaders and other external experts and attendance at relevant scientific meetings, to provide input and guidance for the strategic direction of programs.
• Collaborate with external opinion leaders and Principal Investigators and internal clinicians, translational sciences and clinical operations to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes.
• Maintain current awareness of development and regulatory issues related to competitive compounds in development and how our program(s) or portfolio fits into the competitive landscape.
• Attend and present at investigator meetings and site initiation visits as applicable.
• Provide clinical leadership and contribute to the preparation of protocols, Clinical Study Reports, Annual Reports and other safety reports, Health Authority pre-meeting packages, Investigator Brochures, and other periodic clinical reports.
• Participates with team members to prepare abstracts, manuscripts, and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections)
• Maintains knowledge of ICH-GCP, external regulations and procedures.

Skills, Qualifications and Requirements

• MD/DO degree or equivalent is required
• Board Certification or Board Eligibility in internal medicine with subspecialty training or experience in drug development in cardiopulmonary / respiratory medicine is highly desirable
• Minimum of 5 - 7 years experience conducting clinical research trials in the biopharmaceutical industry, ideally with late phase experience
• Hands on experience in protocol development and clinical trial monitoring
• Experience with U.S. and European Health Authority interactions and submission of clinical regulatory documents is desirable
• Strong written and verbal communication skills; willingness to engage with investigators, key opinion leaders, external advisors, and regulatory authorities; and ability to effectively give presentations at conferences, advisory meetings, and other public forums
• Willingness to educate and mentor internal and external colleagues and collaborators
• Engaged, hands-on, independent, and goal-oriented mentality; willingness to work in highly dynamic work environment and embrace uncertainty
• Self-motivated; strong commitment to follow up on tasks and action items; organizational, analytical, and problem-solving skills; risk identification and management; creative and innovative thinking all highly desirable
• Strong ability to work within and lead and motivate a cross-functional matrixed team
• The requisite scientific acumen and communication skills to influence and collaborate with key scientific, regulatory, and business leaders
• Sound strategic, clinical, technical, operational, and ethical judgment with uncompromising integrity
• Ability to travel as needed

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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued em