Senior Medical Director, Clinical Development Endocrinology - Job ID: 2048
ascendis pharma
DescriptionAscendis 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 Senior Medical Director drives the design, safety monitoring, and data analysis of the Company’s late-phase clinical trials in endocrinology. As such, the Senior Medical Director is an important leader within the clinical development team. The Senior Medical Director will report to the Vice President, Clinical Development, Endocrinology.Key ResponsibilitiesAs the clinical lead of a therapeutic area within endocrinology, responsible for the formulation and implementation of the Clinical Development PlanRepresent clinical development on the Project Core TeamLeverage medical expertise and hands-on clinical experience to promote relevance and rigor of the development programProvide leadership to study teamsFor 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 monitors: oversee all aspects of the clinical monitoring process in accordance with ICH GCPs and global SOPs to assess the safety and efficacy of investigational productsEnsure 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 developmentRepresent 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 meetingsRequirementsM.D. degreeCompletion of an accredited residency and fellowship (strongly preferred)At least 8 years of experience with clinical trial design and executionStrong track record of scientific and clinical inquiryBoard-certified (strongly preferred), with specialty in endocrinology or genetics highly desiredAt least 10 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 a Medical Director position.Possess 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 informationThe estimated salary range for this position is DOE. Actual salary determination is dependent on a variety of factors some of which include: experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package.Benefits401(k) plan with company matchMedical, dental, and vision plansCompany-offered Life and Accidental Death & Dismemberment (AD&D) insuranceCompany-provided short and long-term disability benefitsUnique offerings of Pet Insurance and Legal InsuranceEmployee Assistance ProgramEmployee DiscountsProfessional DevelopmentHealth Saving Account (HSA)Flexible Spending AccountsVarious incentive compensation plansAccident, Critical Illness, and Hospital Indemnity Insurance Mental Health resourcesPaid leave benefits for new parentsAscendis Pharma is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees.A note to recruiters:We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.Job SummaryID: 4BC095B287Department: Clinical Development, EndocrineType: full time
$315k - $345k
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