<h2>Career Category</h2>Clinical Development<h2></h2><h2>Job Description</h2>JOIN AMGEN’S MISSION OF SERVING PATIENTS At 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.Responsibilities<ul><li>Serve as the global development leader for a product team with an enterprise mindset</li><li>Develop the clinical strategy for the product including indications and sequencing</li><li>Partner with clinical operations to deliver the studies</li><li>Manage clinical development medical and/or scientific directors working on various clinical trials for the product</li><li>Provide adequate oversight and mentoring of R&amp;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 profile</li><li>Provide 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&amp;D colleagues</li><li>Drive clinical development components in the writing and data interpretation of CSRs and oversee filing and registration activities</li><li>Review, interpret and present clinical data to internal and external stakeholders</li><li>Provide adequate oversight and mentoring of clinical development colleagues in co-authoring and reviewing clinical sections of regulatory documents</li><li>Lead the evidence generation strategy as well as contribute to content of individual publications, abstracts, and presentations</li><li>Maintain up-to-date knowledge of scientific and clinical published literature</li><li>Interact with KOLs to assure implementation of latest clinical thinking and guidelines into the integrated product development plan</li><li>Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, and consultants</li><li>Provide input/review study start up documentation, e.g., CRF design</li><li>Attend and provide clinical support for investigator and steering committee meetings</li><li>Participate in due diligence and business development activities as needed</li><li>Always operate within Compliance Guidelines</li><li>Provide medical monitoring oversight for clinical trials as required</li></ul>WinWhat 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 Qualifications<ul><li>MD or DO from an accredited medical school AND</li><li>Five (5) years of industry or academic research AND</li><li>Six (6) years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources</li></ul>Preferred Qualifications<ul><li>PhD, MBBS plus accredited residency in relevant sub-specialty, board certified or equivalent</li><li>Ten (10) or more years in biopharmaceutical sponsored clinical research is desirable</li><li>Biopharmaceutical experience as a medical monitor and clinical lead across therapeutic areas is desirable</li><li>Solid understanding of relevant areas such as biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology approaches</li><li>Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements</li><li>Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication</li><li>Ability to analyze and interpret complex datasets</li><li>Exercises initiative in meeting goals and drives innovation in projects</li></ul>They will also embody the Amgen leadership attributes which are:<ul><li>Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive</li><li>Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection</li><li>Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders</li><li>Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results</li></ul>ThriveWhat 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:<ul><li>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.</li><li>A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan</li><li>Stock-based long-term incentives</li><li>Award-winning time-off plans and bi-annual company-wide shutdowns</li><li>Flexible work models, including remote work arrangements, where possible</li></ul>As 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 Range343,334.00 USD - 403,728.00 USD