Job Description Summary

In this role, you will be leading the clinical development strategy of the Contrast Media and Molecular Imaging products under your responsibility in the Oncology domain. You will be responsible for designing and executing clinical development plans across the global businesses. As such, individual will have extensive cross-functional interaction within the Company, ranging from pre-clinical through to clinical, regulatory and commercial functions worldwide.

Our Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world.

Job Description

Roles and Responsibilities

• To provide clinical leadership in cross-functional projects and product/project teams

• To be responsible for the development and validation of the overall medical strategy of the assigned product(s) with appropriate internal or external experts, and for the agreement on this strategy with the appropriate internal business stakeholders

• To be responsible that project activities are planned, agreed and executed according to the milestones and the overall clinical development plan (it includes pre- and post-marketing activities)

• To be responsible for the timely and accurate completion of project documentation such as protocols, amendments, case report forms and study reports

• To verify scientific accuracy of safety and efficacy summaries for regulatory/commercial purposes and to assist with the clinical sections of regulatory dossiers and or product specific scientific discussion, depending on pre or post-marketing activities

• To work closely with the Risk Management, Compliance, Regulatory Affairs and Pharmacovigilance teams to establish and maintain strong risk assessment and management processes for decision making

• To provide input into Risk Management reviews as it relates to patient safety, the performance of risk assessment in the design of clinical studies, and the interpretation of patient safety and risk in the post-market environment

• To collaborate with multiple functions for identifying and selecting innovative products for development

• To work with internal teams and external experts to design clinical development plan and to support clinical research strategies for regulatory approval, reimbursement and adoption.

Required Qualifications

• Medical Degree

• Substantial experience in Pharmaceutical, Biotech, or Contract Research Organization leading to good understanding of Clinical and Industry development of drug products.

• A proven practice in Oncology (preferably with Imaging experience) in both academia and industry is requested.

• Proven experience in Good Clinical Practice (GCP) Clinical trials

• Must be willing to travel as required.

• Experience working with Microsoft office products (Word, Excel, PowerPoint, Outlook)

Desired Characteristics

• Excellent interpersonal, organization, communication, influencing skills.

• Experience in managing KOLs, external experts. Brings his/her own network of KOLs, external experts.

• Experience in scientific publications/communication

• Experience managing complex projects and/or across global regions desirable.

• Good team player with global mindset

• Ability to work independently and with rigor

• Good process knowledge, experience, and skills

• Customer savvy.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Additional Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf) . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Relocation Assistance Provided: No

Application Deadline: July 18, 2024