Executive Director, Clinical Development - Rare Disease

Job title: Executive Director, Clinical Development - Rare Disease in Thousand Oaks, CA at Amgen

Company: Amgen

Job description: Career Category Clinical DevelopmentJob DescriptionJOIN AMGEN’S MISSION OF SERVING PATIENTSAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases.With our focus on four therapeutic areas –Oncology, Rare disease, General Medicine, and Inflammation– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Executive Director, Clinical Development, Rare DiseaseLiveWhat 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 rare 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 rare disease therapeutic area to a range of audiences, including executive leadership, development partners, and global regulatory agencies.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.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 requiredWinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an experienced leader with the following qualifications.Basic QualificationsMD 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 QualificationsPhD, 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 resultsThriveWhat 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 $343,334 - $403,728.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.A discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleAs an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position..Salary Range 343,334.00 USD - 403,728.00 USD

Expected salary:

Location: Thousand Oaks, CA

Apply for the job now!

[ad_2]

Apply for this job