Pulmovant

Director

• 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.

Director, Clinical Development – Pulmovant

• 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.
• 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.

Director, Clinical Development Scientist, Pulmovant

Compliance

• Represent Regulatory Affairs in assigned project meetings and provide regulatory guidance to cross-functional project teams as appropriate; leverage experience in regulatory affairs to provide guidance to colleagues for preparation of regulatory documents
• Serve as regulatory affairs contact for external parties (for example, CROs, advisors) involved in the conduct of Pulmovant’s global clinical trials
• Develop and implement a global regulatory strategy for submissions to support clinical trials and registration in accordance with applicable regulations/guidelines (for example, US FDA, EMA, PMDA, ICH, ISO)
• Plan, prepare, author, and/or review documentation and submissions (for example, IND, CTA, BLA, NDA, MAA) to health authorities to support clinical trials, registration, maintenance of registration, and labeling of pharmaceutical products
• Liaise with global health authorities as needed
• Contribute to the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risks
• Communicate project updates and risks to senior regulatory affairs management and stakeholders across the organization
• Tracking regulatory commitments and deliverables while coordinating with internal and external staff to ensure timely submissions
• Coordinate and prepare responses to requests for information from health authorities
• Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities
• Provide input into the development of internal policy and procedures for regulatory affairs in alignment with GxPs, guidance documents, and corporate objectives
• Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
• Participate in due diligence evaluations of potential in-license/partnering opportunities

Director/Senior Director, Regulatory Affairs

Controller

• Prepare and review monthly, quarterly, and annual financial statements, ensuring compliance with GAAP and internal policies.
• Maintain clinical accruals, including coordination with multiple departments and vendors on a monthly and quarterly basis.
• Manage, mentor, and develop a team of accountants, fostering a culture of continuous improvement and professional growth.
• Assist in the preparation of the annual budget and periodic forecasts, analyzing variances and providing insights to management.
• Design and implement robust internal controls to safeguard assets and ensure the accuracy of financial information.
• Serve as the primary liaison for external auditors; prepare necessary documentation and ensure timely completion of audits.
• Ensure compliance with regulatory requirements and internal policies, including tax regulations and financial reporting standards.
• Work closely with R&D, operations, and other departments to provide financial insights that support business objectives.
• Identify opportunities for process improvements and implement best practices in accounting procedures and systems.

Director, Clinical Development – Pulmovant

Director, Clinical Development Scientist, Pulmovant

Director/Senior Director, Regulatory Affairs

Assistant Controller