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Clinical Research Medical Director
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 Cardiovascular, US - Remote
LiveWhat you will do
Lets do this. Lets change the world.
The Cardiovascular/Metabolic Therapeutic Area is seeking a Clinical Research Medical Director to play a leadership role on one or more studies within olpasiran global development program. In this vital role, you will report directly to the Global Development Lead for the olpasiran product team.
- Provide clinical/scientific knowledge into the development, design, delivery and communication of the global evidence generation plan for the olpasiran phase 3 program.
- 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 clinical study reports, publications and regulatory submissions
- Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Lead
- Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization
- Contribute to TPP (target product profile) and Global Product Safety (GPS) development
- Create development options and present to Global Dev Review Committee (GDRC), Therapeutic Area Governance (TAG)
- Interact with TA leadership and extended team to develop options
- Interact with Center for Design Analysis (CfDA), Center for Observational Research (CfOR), Clinical Pharmacology Modeling & Simulation (CPMS), etc., to bring innovative strategic options.
- Contribute to olpasiran lifecycle management strategic development
- Partner with regulatory to lead registrational activities, including regulatory interactions, development of documents for regulatory submission and discussion, and filing activities
- Partner with Global Development Operations and local organizations (DOMs/Country Medical Directors) to ensure timely delivery of high quality global clinical data
What 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:- Three (3) or more years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
- Five or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
- Strong and versatile clinical development experience in endocrinology or cardiology and accreditation in relevant sub-specialty
- 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 1, 2 and/or 3 clinical trials in obesity or diabetes
- Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
- Leadership experience/potential as a 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 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 plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comAmgen 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.
