[Remote] SR AD / Director, Senior Clinical Program Leader - Pulmonary Fibrosis (Remote)

Note: The job is a remote job and is open to candidates in USA. Boehringer Ingelheim is a global biopharmaceutical company focused on improving lives through innovative healthcare solutions. They are seeking a Director, Senior Clinical Program Leader to oversee clinical development responsibilities for late-stage projects in Pulmonary Fibrosis, providing medical leadership and direction for trial designs and regulatory submissions.ResponsibilitiesRepresents and is responsible for the Therapeutic Area on various workstreams related to the asset(s) being developed, including but not limited to development of trial design outline (TDO) and clinical trial protocol (CTP), pediatric investigational plan development, input into project analysis, results communication, etc. Additional work packages may include medical/scientific contributions to the Investigator Brochure, Company Core Data sheet, Annual Safety Report / IND Safety Reports, as well as preparation for the Milestones Release of Full Development and Release of SubmissionProvides medical oversight to the clinical trial program within their respective project and contributes to continuous benefit-risk assessmentProvides medical leadership in regulatory meetings and contributes to submission strategy, regulatory dossiers, and regulatory authority interactionsOversees medical project budgets for the respective project(s)Serves as the representative of the development team to leadership committees within Medicine, within the TA (Business Unit Portfolio Committee (BUPC)), and to Corporate Leadership (One Human Pharma Executive Committee (OneHP EC)Oversees and supports contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boardsReviews and approves scientific abstracts and publications within his/her project in collaboration with the Clinical Development Lead, Head of Medicine (HOM) or Head of Clinical Development, InflammationIdentifies and provides input to Medical Affairs evidence gaps, strategy documents, publications, and Product Maintenance and Optimization (PMO)SkillsMD (specialist in respective TA) ideally with clinical pulmonary experience (fellowship training / ILD expertise preferred) and extensive experience across all stages of clinical drug developmentPhD with three to five (3-5) years of experience in respective TA ideally with clinical pulmonary or other related Therapeutic areas and extensive experience across all stages of clinical drug developmentMD (specialist in respective TA) ideally with clinical pulmonary experience (fellowship training / ILD expertise preferred) and extensive experience across all stages of clinical drug developmentPhD with ten-plus (10+) years' experience in Pulmonary or other related Therapeutic Areas and extensive experience across all stages of clinical drug developmentAbility to thoroughly evaluate key study concepts including background, sample size, statistics, design, timing, feasibility and budgetingSuccessful track record in planning, conducting, and publishing of Basic Science and/or Clinical ResearchSound medical and scientific leadership to drive high-priority projects in collaboration with global matrix teams, regional BI counterparts and external partnersAbility to act with grace and resilience under pressureGood project management skillsPrevious interactions with regulatory authorities, and participation in international societies and other relevant international stakeholdersGood communication and presentation skillsExcellent cross-functional collaboration skills and ability to work in virtual teamsMust be legally authorized to work in the United States without restrictionMust be willing to take a drug test and post-offer physical (if required)Must be 18 years of age or olderBenefitsThe position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements.Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance.Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare.Company OverviewBoehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim. It was founded in 1885, and is headquartered in Ingelheim Am Rhein, Rheinland-Pfalz, DEU, with a workforce of 10001+ employees. Its website is https://www.boehringer-ingelheim.com/.