Clinical Development Director, Obesity/Cardiovascular

Career Category Clinical Development Job Description 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, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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. Clinical Development Director, Obesity/Cardiovascular What you will do Let’s do this. Let’s change the world. Amgen is advancing our Obesity and Cardiometabolic pipeline. We need collaborative and innovative world-class talent to ensure these molecules become medicines and reach their full potential while helping patients. The Obesity Therapeutic Area is seeking a Clinical Development Director to play a vital role on one or more late phase studies within the maridebart cafraglutide (AMG 133) global development program in obesity and related metabolic diseases. In this role, you will report directly to the Global Development Lead for cardiovascular indications. Provide clinical/scientific knowledge into the development, design, delivery and communication of the global evidence generation plan for maridebart cafraglutide (AMG 133) phase 3 program(s). Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents Provide clinical input into & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results. Serve as medical monitor for ongoing clinical trials Review and analyze clinical trial data to ensure accuracy, completeness and adherence to protocol and regulatory requirements Participate and provide clinical input into safety and regulatory interactions Author clinical study reports, publications and regulatory submissions Develop relationships with key opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Lead What we expect of you We are all different, yet we all use our unique contributions to serve patients. The medical professional we seek is a leader with these qualifications. Basic Qualifications: MD or DO degree from an accredited medical school AND 3 years of clinical research experience Preferred Qualifications: Three (3) or more years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company), ideally in late phase development in a cardiometabolic or adjacent therapeutic area. Five or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 2 and/or 3 clinical trials in obesity, diabetes or cardiovascular indications Experience with clinical trial medical data review, medical monitoring and or safety review and interpretation, including use of electronic aggregate data review tools Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions Strong communication & presentation skills to clearly communicate scientific concepts in both written and oral communication Strong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution path Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements Leadership experience/potential as a medical expert in a complex matrix environment What you can expect of us As 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 expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. 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: A 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 plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline 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. Sponsorship Sponsorship for this role is not guaranteed. 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 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. . Salary Range USD - USD