Executive Director, Clinical Development, - Thousand ...

Job DescriptionATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.What you will doLet's do this. Let's change the world. In this vital role as an Executive Director, you will play an important role in scientific strategy and planning and execution for all aspects of clinical drug development across Amgen's clinical programs.This Executive Director within Clinical Development will be involved with the full scope of the General Medicine disease clinical drug development activities from the design and execution of Phase 2 through Phase 4 studies.They will serve as the principal representative for global development within the General Medicine therapeutic area to a range of audiences, including executive leadership, development partners, and global regulatory agencies.The General Medicine portfolio encompasses a broad array of therapeutic areas that include cardiovascular disease and prevention, renal disease, neurological, endocrine disease including bone diseases, among others. It does not include oncology and inflammatory diseases.This role will include global development leadership of one or more assets within the portfolio and require people management activities. The position will work closely with all members of the cross-functional product team to apply full clinical knowledge to successfully advance clinical programs, as well as the overall product strategy.The Executive Director will report into the Vice President, Global Clinical Development General Medicine.ResponsibilitiesServe as the global development leader for a product team with an enterprise mindsetDevelop the clinical strategy for the product including indications and sequencingPartner with clinical operations to deliver the studiesManage clinical development medical and/or scientific directors working on various clinical trials for the productProvide adequate oversight and mentoring of R&D personnel to design clinical development plans and protocols spanning all phases of development per indication in collaboration with product team members, key opinion leaders (KOLs) and CROs that are aligned with the target product profileProvide adequate oversight into the development of the primary and secondary endpoints for efficacy and safety as well as contribute to the biostatistics analysis plan, and clinical study reports (CSRs) along with biostatistics and other R&D colleaguesDrive clinical development components in the writing and data interpretation of CSRs and oversee filing and registration activitiesReview, interpret and present clinical data to internal and external stakeholdersProvide adequate oversight and mentoring of clinical development colleagues in co-authoring and reviewing clinical sections of regulatory documentsLead the evidence generation strategy as well as contribute to content of individual publications, abstracts, and presentationsMaintain up-to-date knowledge of scientific and clinical published literatureInteract with KOLs to assure implementation of latest clinical thinking and guidelines into the integrated product development planServe as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, and consultantsProvide input/review study start up documentation, e.g., CRF designAttend and provide clinical support for investigator and steering committee meetingsParticipate in due diligence and business development activities as neededAlways operate within Compliance GuidelinesProvide medical monitoring oversight for clinical trials as requiredAdditional Qualifications/ResponsibilitiesWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Executive Director we seek is an experienced leader with the following qualifications.Basic Qualifications:MD or DO from an accredited medical school ANDFive (5) years of industry or academic research ANDSix (6) years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resourcesPreferred Qualifications:PhD, or MBBS plus accredited residency in relevant sub-specialty, board certified or equivalentTen (10) or more years in biopharmaceutical sponsored clinical research is desirableBiopharmaceutical experience as a medical monitor and clinical lead across therapeutic areas is desirableSolid understanding of relevant areas such as biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology approachesKnowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirementsAbility to effectively present ideas and document complex medical/clinical concepts in both written and oral communicationAbility to analyze and interpret complex datasetsExercises initiative in meeting goals and drives innovation in projectsThey will also embody the Amgen leadership attributes which are:Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thriveAccelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfectionIntegrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholdersAdapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver resultsWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.The annual base salary range for this opportunity in the U.S. is $361,379 - $414,638

Created: 2026-04-15