[Remote] Senior Director, Clinical Development Scientist, Pulmovant

Remote Full-time
Note: The job is a remote job and is open to candidates in USA. Pulmovant is a Roivant-backed clinical-stage biotechnology company focused on developing innovative therapies for pulmonary diseases. The Senior Director, Clinical Development Scientist will oversee clinical development strategy and execution, as well as lead scientific publications and communications, ensuring effective collaboration and adherence to regulatory standards.ResponsibilitiesSupporting the design and execution of key elements of the Clinical Development Plan (clinical study or studies) and associated data collection activities, within a therapeutic areaContribute to the development of study concepts, protocol designs, and study essential documents by liaising with other functions and arranging external expert consultations, as neededEngage 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 strategyCollaborating 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 documentsMaintaining 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 reviewReviewing and synthesizing scientific literature and competitive intelligence to support study and program strategySupporting development of publications arising from studies and other relevant initiativesWhere appropriate, serve as the SME for identification, translation, inclusion, implementation, and reporting related to liquid, tissue and/or imaging endpointsLiaising with other functions to enable quality clinical study execution, by ensuring knowledge of the protocol, implementing effective quality control procedures and monitoring their executionParticipate in the development of clinical study protocol concept sheets and protocols, study operations manuals, and other study essential documentsParticipating in Investigator meeting planning and execution and/or site initiation meetingsMonitoring, cleaning, analyzing, and reviewing safety and efficacy data to establish the presence or absence of trends and follow up as appropriateSupport 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 studiesProviding support for business development activities, such as due diligence and research collaborationsDevelop and implement scientific publication and communication plans that align with product strategiesLead scientific content development for congresses, managing publication deliverables (manuscripts and presentations), and project management across cross-functional teams to ensure timely deliveryEnsure 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 rigorManage external vendors, medical writers, and the associated annual budget for publication and scientific communication activitiesSkillsAdvanced scientific degree (M.S., Ph.D., Pharm D., MPH or similar degree)Understanding of general (and specific) therapeutic principles including therapeutic area experienceKnowledge in the principles of clinical research methodology, statistics, data analysis and interpretationFamiliar with scientific literature searches and weighing of quality peer reviewed dataAbility to clearly communicate to internal and external stakeholders orally and in writingBasics of strategic vs. tactical thinkingStrong written and oral presentation skillsFosters a collaborative work environment; has skills demonstrating leadership and ability to lead by influenceExperience in interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etcStrong 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-resultsEngage in problem solving and non-linear thought, analysis, and systematic thinkingCompany OverviewPulmovant develops investigational therapies for respiratory diseases and shares pipeline and clinical study information. It was founded in undefined, and is headquartered in Waltham, Massachusetts, USA, with a workforce of 11-50 employees. Its website is https://www.pulmovant.com.Company H1B SponsorshipPulmovant has a track record of offering H1B sponsorships, with 1 in 2026. Please note that this does not guarantee sponsorship for this specific role.

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