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Clinical Research Medical Director
3 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 - BiosimilarsLive
What you will do
Lets do this. Lets change the world. In this vital role you will serve as a medical expert for the Biosimilar development products at each stage of its clinical development in alignment with the Global Development Lead. The CRMD is an integral cross-functional partner with the Operations, Regulatory Affairs, Clinical Development Operations, Biostatistical, Safety, Scientific Affairs, and other groups.
This Role is responsible for:
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 interactions Key Activities: Provide clinical/scientific input during the development and execution of clinical trialsInterpret clinical trial dataParticipate in safety assessmentsParticipate in interactions with regulatory agenciesAuthor clinical study reports, publications, and regulatory submissionsDevelop key opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Leader (GDL)Support new clinical research opportunitiesSupport in-licensing and out-licensing activities and partner relationshipsSupport product lifecycle management as directed by GDLWinWhat 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 Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting Preferred Qualifications:MD plus completion of an accredited residency with experience in biosimilars, oncology, hematology, rheumatology, allergy/immunology, gastroenterology, ophthalmology, or related disease areas5 years of clinical research experience and/or basic science research combined with clinical teaching and patient care activitiesDrug development experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)ThriveWhat 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. 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. 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.