Descripción de la oferta
Clinical Development Director - OncologyCareer Category Clinical Job DescriptionJoin 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.What you will doLet’s do this. Let’s change the world.Supporting the development, execution and communication of the global scientific/medical evidence planSupporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development programSupporting the development of key scientific external relationships with opinion leadersParticipating and providing clinical input into safety and regulatory interactionsProviding clinical/scientific input during the development and execution of clinical trialsInterpret clinical trial dataParticipate in safety assessmentsParticipate in interactions with regulatory agenciesAuthor CSRs, publications and regulatory submissionsDevelop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development LeaderIdentify new clinical research opportunitiesSupport in-licensing and out-licensing activities and partner relationshipsSupport product lifecycle management for new indications as directed by Global Development LeaderProvide clinical content input to: Regulatory interactions and documentsSafety interactions and documentsMaterials to be used in Scientific AffairsMaterials to be used by the Commercial OrganizationWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The clinical development professional we seek has these qualifications.Basic QualificationsMD or DO degree from an accredited medical school AND 2 years of clinical research experience and/or basic science researchPreferred Qualifications5+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities, particularly in GU Oncology (prostate cancer)Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationaleFamiliarity with concepts of clinical research and clinical trial design, including biostatisticsSound scientific and clinical judgmentKnowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirementsAbility to effectively present ideas and document complex medical/clinical concepts in both written and oral communicationDemonstrated ability as a medical expert in a complex matrix environmentHistory of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issuesWhat you can expect of usThe 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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models where possibleSponsorshipSponsorship for this role is not guaranteed.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.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.Salary Range 274,788.85USD -371,773.15 USDAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.Amgen.Com and follow us on www.Twitter.Com/amgen#J-18808-Ljbffr
