Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.
Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.
Guided by our core values of Patients, Science, and Passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.
The Medical Director is involved in the design, safety monitoring, and data analysis of the Company's late-phase clinical trials in endocrinology. As such, the Medical Director is an important and visible member of the clinical development team. The Medical Director position is based in the United States (preferably in Palo Alto, California) and will report to the Vice President, Clinical Development.
Key ResponsibilitiesContribute to formulation and implementation of the Clinical Development PlanLeverage medical expertise and hands-on clinical experience to promote relevance and rigor of the development programFor clinical trials: design, provide overall oversight, and support site and subject retentionServe as a Medical Monitor for clinical trials, ensure study integrity, and track accumulating safety and efficacy dataProvide leadership to teams of medical monitorsProvide leadership to study teamsEnsure successful completion of trial-related documents (including clinical trial protocols, investigator brochures, medical monitoring plans, site training materials, clinical study reports, health authority responses, standard operating procedures, etc.) with cross-functional team membersAnalyze, evaluate, interpret, and report clinical dataAnticipate and solve complex drug development problemsContribute to regulatory strategyContribute to drafting and reviewing of clinical documents, manuscripts, presentations, and regulatory submissionsMaintain up-to-date knowledge of relevant science, medical information, good clinical practices, and regulatory guidanceCollaborate with—and serve as a clinical research resource for—cross-functional colleagues (e.g. in clinical operations, statistics, regulatory affairs, medical affairs, health economics outcomes research, commercial, finance) to optimize product developmentContribute to (and may be asked to represent the clinical development department in) corporate strategic and organizational initiativesCultivate relationships with investigative sites, clinical consultants, and key opinion leaders to represent the interests of the companyAssist in portfolio management and commercial activities as neededComplete assigned tasks thoroughly, accurately, and on timeAdhere to rigorous ethical standardsTravel up to 20% domestically and internationally for scientific meetingsKnowledge, Skills and ExperienceM.D. degreeCompletion of ACGME-accredited residency and fellowship (strongly preferred)Physician licensure in at least one state (strongly preferred)Board-certified (strongly preferred), with specialty in endocrinology highly desiredAt least 5 years of industry experience (other relevant experience e.g. post-graduate experience in the clinical and/or academic realms may also be considered on a case-by-case basis). Those with less experience may be considered for an Associate Medical Director position.At least 3 years of experience with clinical trial design and executionStrong track record of scientific and clinical inquiryPossess excellent communication skills (written and oral)Learn quickly, follow complex directions under pressureMulti-task while remaining organized and attentive to detailLead both directly and by exampleWork hard, be a trustworthy and collaborative team playerTake initiative and solve complex problemsDemonstrate sound judgement in terms of handling complex, confidential, and regulated informationSalary range: $265-285K/year
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