Amgen Careers – Executive Medical Director

Job Summary

Amgen currently has a vacancy for those looking to work as a Amgen Careers – Executive Medical Director for Full Time at their offices in Thousand Oaks, CA, US. Applicants should be sure to read the job outline attentively if they intend to apply.

Job Title:	Amgen Careers – Executive Medical Director
Company Name:	Amgen
Job Location:	Thousand Oaks, CA, US
Job Type:	Full Time
Job Category:	Amgen
Job Link Expiry:	2023-12-30
Posted on:	Jobinton.com

Job Details:

Job Description:

Let’s do this. Let’s change the world. In this vital role the Executive Medical Director will provide science-based evaluation of product quality and device, companion diagnostic and digital health safety issues for Amgen products.

Job Responsibilities:

• Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance (PV) System Master File and maintain a state of inspection readiness
• Act as the representative and point of contact for Health Authority Inspections and Internal Process Audits
• Lead all CPS (Combination Product Safety) staff in the assessment and management of combination product safety issues
• Ensure that CPS staff report assessment activities that take place for device complaints and malfunctions
• Perform management activities for direct reports, including mentoring, career development, and training, etc.
• Provide clinical input in the development and maintenance of digital heath technology assets
• Engage as a Safety expert in the therapeutic area and be accountable for the safety strategy, and major safety deliverables of the combination product therapeutic area
• Lead and provide medical oversight to CPS staff in the authoring of combination product risk/benefit analyses
• Lead CPS staff input to combination product risk management documents (hazard analysis, user risk assessments, etc.) for clinical and commercial products
• Have expertise in combination product safety data collection, analysis and reporting in clinical trials. As well as post market surveillance and reporting, risk assessments, Human Factors study protocols and reports, and benefit/risk analyses
• Manage therapeutic area safety teams and be accountable for the staff management and resource planning/allocation
• Review adverse event data to detect potential product quality issues for commercial products
• Participate as a core member of Global Patient Safety (GPS) and Leadership Team to support the GPS, Vice President in the establishment of a highly effective global safety organization that will be in full compliance to worldwide regulations for combination products
• Assess the potential impact of quality findings on patient/user safety for all clinical and commercial products

Job Requirements:

• An understanding of device risk management methodology, tools, and terminology; including human factors engineering methodology
• At least 5 years of experience with pharmaceutical/biotechnology/device pharmacovigilance/risk management
• Knowledge of global regulatory requirements, standards, and guidance’s for pharmacovigilance/ risk management in relation to combination products and standalone devices
• Familiarity with cGMP requirements and processes for drugs/biologics and devices/combination products
• An understanding of clinical and commercial drug/biologic pharmacovigilance/risk management processes

Qualification & Experience:

• MD or DO from an accredited medical school AND
• Five or more years of in industry and/or academic clinical research AND
• 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Job Details:

Company: Amgen

Vacancy Type: Full Time

Job Location: Thousand Oaks, CA, US

Application Deadline: N/A

Apply Here

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