Director, Clinical Development Scientist, Pulmovant

Pulmovant

About The Position

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 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.

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.

Responsibilities

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.