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 is ongoing. 

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. 

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

Position: 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 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.   

Key Duties 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 3 – 5 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 employment. An employer who violates this law shall be subject to criminal penalties and civil liability. 

 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! 

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 is ongoing.

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 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; 8 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: Senior Director, Clinical Development Scientist, Pulmovant

Position Summary:

The responsibilities are across 2 main areas: clinical development strategy and execution (75%) and leading and managing scientific publications and communications strategy and execution (25%).

The responsibilities described below may also be delegated to other team members or external collaborators (vendors, consultants) and would entail management of these individuals or entities.

Key Responsibilities:

Clinical Development

• Supporting the design and execution of key elements of the Clinical Development Plan (clinical study or studies) and associated data collection activities, within a therapeutic area.
• Contribute to the development of study concepts, protocol designs, and study essential documents by liaising with other functions and arranging external expert consultations, as needed.
• Engage with clinical investigators on clinical studies to enable quality clinical execution, analyze and interpret clinical data, and collaborate with the broader team to define the clinical strategy.
• Collaborating on, or leading where appropriate, the preparation of clinical study related documents including protocols, charters, statistical analyses plans and summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
• Maintaining awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
• Reviewing and synthesizing scientific literature and competitive intelligence to support study and program strategy
• Supporting development of publications arising from studies and other relevant initiatives.
• Where appropriate, serve as the SME for identification, translation, inclusion, implementation, and reporting related to liquid, tissue and/or imaging endpoints.
• Liaising with other functions to enable quality clinical study execution, by ensuring knowledge of the protocol, implementing effective quality control procedures and monitoring their execution.
• Participate in the development of clinical study protocol concept sheets and protocols, study operations manuals, and other study essential documents.
• Participating in Investigator meeting planning and execution and/or site initiation meetings.
• Monitoring, cleaning, analyzing, and reviewing safety and efficacy data to establish the presence or absence of trends and follow up as appropriate.
• Support CROs/ CRAs on study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures. Finally, engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.
• Providing support for business development activities, such as due diligence and research collaborations.

Scientific Publications and Communications

• Develop and implement scientific publication and communication plans that align with product strategies.
• Lead scientific content development for congresses, managing publication deliverables (manuscripts and presentations), and project management across cross-functional teams to ensure timely delivery
• Ensure all publications and communications adhere to international regulatory guidelines, ethical standards, industry standards and internal SOPs. This includes critically reviewing content for scientific accuracy and rigor.
• Manage external vendors, medical writers, and the associated annual budget for publication and scientific communication activities.

Skills, Qualifications, and Requirements:

• Advanced scientific degree (M.S., Ph.D., Pharm D., MPH or similar degree).
• Understanding of general (and specific) therapeutic principles including therapeutic area experience.
• Knowledge in the principles of clinical research methodology, statistics, data analysis and interpretation
• Familiar with scientific literature searches and weighing of quality peer reviewed data
• Ability to clearly communicate to internal and external stakeholders orally and in writing
• Basics of strategic vs. tactical thinking.
• Strong written and oral presentation skills.
• Fosters a collaborative work environment; has skills demonstrating leadership and ability to lead by influence.
• Experience in interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.
• Strong business acumen: including in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results
• Engage in problem solving and non-linear thought, analysis, and systematic thinking.

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 employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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!