[Remote] Director, Clinical Development, Pulmovant

Note: The job is a remote job and is open to candidates in USA. Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. The Director of Clinical Development will be responsible for the design and execution of clinical trial activities, ensuring high value clinical data and maintaining relationships with key opinion leaders and Health Authorities.ResponsibilitiesProvide clinical and scientific input to study design, protocol concepts and development, statistical analysis plans and reporting to drive high value clinical dataMedical strategic oversight and accountability for the formulation of study designs, protocol development, and regulatory documents in collaboration with cross-functional teamProvide 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 standardsRemain 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 programsCollaborate 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 outcomesMaintain current awareness of development and regulatory issues related to competitive compounds in development and how our program(s) or portfolio fits into the competitive landscapeAttend and present at investigator meetings and site initiation visits as applicableProvide 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 reportsParticipates 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 proceduresSkillsMD/DO degree or equivalent is requiredBoard Certification or Board Eligibility in internal medicine with subspecialty training or experience in drug development in cardiopulmonary / respiratory medicine is highly desirableMinimum of 3 – 5 years experience conducting clinical research trials in the biopharmaceutical industry, ideally with late phase experienceHands on experience in protocol development and clinical trial monitoringExperience with U.S. and European Health Authority interactions and submission of clinical regulatory documents is desirableStrong 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 forumsWillingness to educate and mentor internal and external colleagues and collaboratorsEngaged, hands-on, independent, and goal-oriented mentality; willingness to work in highly dynamic work environment and embrace uncertaintySelf-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 desirableStrong ability to work within and lead and motivate a cross-functional matrixed teamThe requisite scientific acumen and communication skills to influence and collaborate with key scientific, regulatory, and business leadersSound strategic, clinical, technical, operational, and ethical judgment with uncompromising integrityAbility to travel as neededCompany 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.