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Clinical Research Medical Director, Late Development GI Oncology
4 months ago
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
Clinical Research Medical Director, OncologyLive
What you will do
Lets do this. Lets change the world. The Oncology Therapeutic Area within Global Development is rapidly growing and 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.
Serve as gastrointestinal cancer clinical expert to provide clinical/scientific knowledge into the development, execution and communication of the global scientific/medical evidence plan for the indicationServe as the medical monitor on key clinical trials in gastrointestinal oncologySupport cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development programParticipate and provide clinical input into safety and regulatory interactionsInterpret and communicate clinical trial dataAuthor 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 GDLIdentify new clinical research opportunitiesSupport in-licensing and out-licensing activities and partner relationshipsSupport product lifecycle management for new indications as directed by Global Development LeadProvide clinical content input to materials to be used in Scientific Affairs as well as the Commercial OrganizationWinWhat 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:5+ years of clinical development experience in industryCompletion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) settingMD with strong and versatile clinical development experience in gastrointestinal oncology, and accreditation in relevant sub-specialtyKnowledge of pharmaceutical product development, product lifecycle, and commercialization processesExperience 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 1,2 and/or 3 clinical trialsKnowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements. Leadership experience/potential as a colorectal cancer medical expert in a complex matrix environmentAbility to effectively present ideas and document complex medical/clinical concepts in both written and oral communicationStrong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution pathThriveWhat you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. 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. Amgen offers a Total Rewards Plan comprising 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 including: 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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 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.