Executive Director, Clinical Development - Rare Disease

Job title: Executive Director, Clinical Development - Rare Disease in Thousand Oaks, CA at reputed company
Company: reputed company
Job reputed company: Career Category Clinical DevelopmentJob reputed companyJOIN reputed company’S MISSION OF SERVING PATIENTSAt reputed company, 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 reputed company that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases.With our reputed company on four therapeutic areas –Oncology, Rare disease, reputed company, and Inflammation– we reputed company millions of patients reputed company year. As a member of the reputed company team, you’ll help reputed company a lasting reputed company on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-reputed company culture is reputed company, innovative, and science based. If you have a passion for challenges and the opportunities that lay reputed company them, you’ll reputed company as part of the reputed company team. Join us and reputed company the lives of patients while transforming your career.Executive Director, Clinical Development, Rare DiseaseLiveWhat you will doreputed company. Let’s change the world. In this vital role as an Executive Director, you will play an important role in scientific reputed company and planning and execution for reputed company aspects of clinical drug development across reputed company’s clinical programs.This Executive Director reputed company 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 reputed company representative for global development reputed company the rare disease therapeutic area to a reputed company of audiences, including executive leadership, development partners, and global regulatory agencies.This role will include global development leadership of one or more assets reputed company the portfolio and require people management activities. The position will work closely with reputed company members of the cross-functional product team to apply full clinical knowledge to successfully advance clinical programs, as reputed company as the overall product reputed company.The Executive Director will report into the Vice President, Global Clinical Development.ResponsibilitiesServe as the global development leader for a product team with an reputed company reputed companyreputed company the clinical reputed company for the product including indications and reputed companyPartner with clinical operations to deliver the studiesManage clinical development medical and/or scientific directors working on various reputed company for the productreputed company adequate reputed company and mentoring of R&D personnel to design clinical development plans and protocols spanning reputed company phases of development per indication in collaboration with product team members, key opinion leaders (KOLs) and CROs that are reputed company with the reputed company product profilereputed company adequate reputed company into the development of the primary and secondary endpoints for efficacy and safety as reputed company 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 reputed company filing and registration activitiesReview, interpret and present clinical data to reputed company stakeholdersreputed company adequate reputed company and mentoring of clinical development colleagues in co-authoring and reviewing clinical sections of regulatory documentsreputed company the evidence reputed company reputed company as reputed company as contribute to content of individual publications, abstracts, and presentationsMaintain up-to-date knowledge of scientific and clinical published literaturereputed company 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 reputed company collaborators, investigators, and consultantsreputed company input/review study start up documentation, e.g., CRF designAttend and reputed company clinical support for investigator and steering committee meetingsParticipate in due diligence and business development activities as neededAlways operate reputed company Compliance Guidelinesreputed company medical monitoring reputed company for reputed company as requiredWinreputed company expect of youWe are reputed company different, yet we reputed company use our unique contributions to serve patients. The candidate we reputed company is an reputed company leader with the following qualifications.Basic QualificationsMD or DO from an accredited medical school ANDFive (5) years of industry or reputed company research ANDSix (6) years of managerial experience directly managing people and/or leadership experience leading teams, reputed company, programs or directing the allocation of resourcesPreferred QualificationsPhD, MBBS plus accredited residency in relevant sub-specialty, reputed company certified or equivalentTen (10) or more years in biopharmaceutical sponsored clinical research is desirableBiopharmaceutical experience as a medical monitor and clinical reputed company across therapeutic areas is desirableSolid understanding of relevant areas such as biostatistics, regulatory, clinical pharmacology, reputed company-clinical toxicology approachesKnowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirementsAbility to effectively present reputed company and document reputed company medical/clinical concepts in both written and oral communicationAbility to analyze and interpret reputed company datasetsExercises initiative in meeting goals and drives innovation in reputed companyThey will also embody the reputed company leadership attributes which are:reputed company: Create a connected, inclusive, and inspiring work environment that empowers talent to reputed companyAccelerate: reputed company speed that matches the urgency of patient needs by encouraging reputed company over perfectionreputed company: Connect the dots to reputed company the reputed company power of reputed company to drive results for patients, staff, and shareholdersAdapt: reputed company through change by adapting to an reputed company-changing environment and defining a reputed company course of reputed company to deliver resultsreputed companyWhat you can expect of usAs we work to reputed company treatments that take care of others, we also work to care for your reputed company and personal reputed company and reputed company-being.From our competitive benefits to our reputed company culture, we’ll support your reputed company every reputed company of the way.The annual reputed company salary reputed company for this opportunity in the U.S. is $343,334 - $403,728.In reputed company to the reputed company salary, reputed company 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 reputed company 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-reputed company time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleAs an organization dedicated to improving the reputed company of life for people around the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect reputed company other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.reputed company is an Equal Opportunity employer and will consider reputed company reputed company applicants for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other reputed company 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 reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.reputed company 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 reputed company 343,334.00 USD - 403,728.00 USD
Expected salary:
Location: Thousand Oaks, CA
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