Clinical Research Medical Director, Rare Disease, Late Development, US-Remote
1 month 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, Rare Disease, Late Development, US-Remote
Live
What you will do
Lets do this. Lets change the world. In this vital role you will contribute to all clinical development executional activities involved in currently running Phase 3 clinical studies. This includes conducting related data review activities, managing interactions with CROs, and ensuring the safety of enrolled subjects. Additionally, you will play a key role in supporting submission activities for upcoming regulatory filings, such as sBLA and Type II variation. Furthermore, they will contribute to the planning of future critical studies in the rare disease area, including Phase 2 and/or direct-to Phase 3 studies. This position is within the Rare Disease Clinical Development organization, aligned to UPLIZNA.
Responsibilities:
Serve as clinical expert to provide clinical/scientific knowledge into the development, delivery and communication of the global scientific/medical evidence plan for the indication(s).Provide oversight of LCM clinical development with input on global strategySupport cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access, and value input into the development program(s)Participate and provide clinical input into safety and regulatory interactions.Interpret and communicate clinical trial data.Author/review 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 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 LeadProvide clinical content input to materials to be used in Scientific Affairs as well as the Commercial OrganizationApproximate 10% travel may be required. Knowledge: In-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale.In-depth understanding of and demonstrated success in how to conceptualize, design, and conduct complex, global clinical trials in all phases of development especially Ph2/3 registrational trials.Medical knowledge in the relevant therapeutic areaSound scientific and clinical judgment.Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups.Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirementsPrior experience of regulatory interactions, authoring filing IND or BLA experienceUnderstanding of new drug commercialization and business practicesUnderstanding of resourcing and budgetingWinWhat 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 2 years of clinical research experience and/or basic science research Preferred Qualifications:Late stage drug discovery and development experienceMD plus accredited residency in relevant sub-specialty, board certified or equivalent.Three (3) or more years of clinical development experience and/or basic science research combined with clinical teaching and patient care activities.Clinical development experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)Experience in development lifecycle management to include development strategy creation for large programs from early development, through late development and commercialization.Involved in filing activities as part of the moving the program through the development lifecycle.Key relationship development and collaboration with the expansive commercial and medical teams internal and external partners and key opinion leaders.Previous management experience of clinical development professionals and successful prior experience seeking and developing talent.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 annual base salary range for this opportunity in the U.S. is $256,334. to $318,868. In addition to the base salary, 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.We have other current jobs related to this field that you can find below
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