Washington D.C., DC, 20080, USA
25 days ago
Clinical Research Medical Director, NSCLC
**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. 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 Research Medical Director **What you will do** Let’s do this. Let’s change the world. In this vital role you will have an opportunity to shape this Therapeutic Area. This role will report directly to the Global Development Lead for a program. **Responsibilities:** + Provide therapeutic area expertise in lung cancer and contribute to the development, execution, and communication of the global scientific/medical evidence plan for thoracic oncology + Serve as the medical monitor on key clinical trials in lung cancer + Conduct medical review of clinical trial data + Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program + Participate and provide clinical input into safety and regulatory interactions + Author CSRs, publications, and regulatory submissions + Lead interactions with key opinion leaders and deliver presentations at advisory boards, key scientific meetings and external committee meetings as delegated by GDL + Identify new clinical research opportunities + Support in-licensing and out-licensing activities and partner relationships + Support product lifecycle management for new indications as directed by Global Development Lead + Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. **Basic Qualifications:** MD or DO degree from an accredited medical school AND 2 years of clinical research experience and/or basic science research **Preferred Qualifications:** + MD with fellowship training and board certification in Oncology with demonstrated clinical development experience in thoracic oncology + 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 + Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements. + Leadership experience/potential as a lung cancer medical expert in a complex matrix environment + Ability to effectively present ideas and document complex medical/clinical 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 **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, including remote and hybrid work arrangements, where possible **Apply now** **for a career that defies imagination** Objects in your future are closer than they appear. Join us. **careers.amgen.com** 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. 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.
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