[Remote] Vice President, Clinical Development

Note: The job is a remote job and is open to candidates in USA. Precision Medicine Group is seeking an experienced and passionate regulatory physician for the role of Vice President, Clinical Development. The successful candidate will drive product development for drugs, biologics, and cell and gene therapies focusing on regulatory strategy and clinical development for autoimmune conditions.ResponsibilitiesReports to Chief Medical Officer, and across Precision for Medicine, supporting medical strategyProvides medical and strategic support for business development activities globally including client engagement, proposal support, client capabilities meetings, and professional meetingsProvides strategic drug development consulting to autoimmune, rare and orphan disease clients. The consulting will be provided in the context of an integrated strategy with medical, clinical, regulatory, biostatistical, translational and marketing insightsCreate, review, or revise protocols, case report forms, training materials, project-specific tools, analysis plans, study designs, clinical trial reports, and investigational new drug applicationsReview laboratory values, adverse events, coding dictionaries and data tables, listings and figures as neededParticipate and drive feasibility discussions relating to specific project proposalsDevelop training modules and conducts training for project teams and colleagues as necessaryEnsure high quality, data driven deliverables that meet the highest standards of medical, ethical, and scientific integrity and conductPropose strategies to manage and accelerate timelines for drug development strategiesEnsures customer satisfaction by working closely with senior management, PFM operations, to provide optimum strategic consultancy to clientsSkillsSuccessful completion of MD, MBBS, or equivalent training plus completion of training including a fellowship (Endocrinology, Rheumatology, Hematology-Oncology or other related field, board certification preferred, including European equivalents)Experience in direct interactions with US and/or EU Regulatory AuthoritiesAt least 10 years of senior leadership experience in the clinical research industry with a demonstrated knowledge and substantial experience including related disciplines (i.e. operations, medical monitoring, biostatistics, regulatory, preclinical, translational pharmacology, etc.) Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the jobThe ability to travel domestically and/or internationally for Client and/or Health Authority Meetings and Thought Leadership/Conference AttendancePreference will be given to candidates with recent previous health authority experience (current or ex-FDA medical reviewers, etc.)Clinical experience with previous exposure to regulatory and statistical activities such as (co) authoring and reviewing of documents such as clinical trial protocols, statistical analysis plans, IND, NDA, PSUR, DSUR, IB, ICF, Breakthrough Designation, and regulatory briefing documentsWorking knowledge of the safety reporting process globallyBenefitsDiscretionary annual bonusHealth insuranceRetirement savings benefitsLife insuranceDisability benefitsParental leavePaid time off for sick leave and vacationCompany OverviewWe founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market. It was founded in 2012, and is headquartered in Bethesda, Maryland, USA, with a workforce of 1001-5000 employees. Its website is https://www.precisionmedicinegrp.com/pfm/.