Medical Advisor in Solid Tumor Area

Amgen; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a talented medical strategist to lead product medical strategy and collaborate with cross-functional teams. This role is integral in developing and executing local product lifecycle management plans while ensuring compliance with regulations. The ideal candidate will have a strong background in oncology, experience in clinical study management, and exceptional communication skills. Join this innovative firm to make a significant impact in the pharmaceutical landscape, driving scientific programs and fostering relationships with key opinion leaders. This is an exciting opportunity to contribute to groundbreaking medical advancements.

Qualifications

• 2+ years in pharmaceutical industry or academia collaboration.
• Experience in medical department or clinical development.

Responsibilities

• Lead product medical strategy and plan based on product strategy.
• Develop collaborative relationships with scientific experts and study sites.

Skills

Oncology knowledge

Clinical study management

Medical and scientific expertise

Fluency in English

Strong communication skills

Education

Master’s degree

MD, PharmD, or PhD (preferred)

Job description

Career Category: Scientific

Job Description

Job purpose

• Lead and develop product medical strategy and plan based on product strategy.
• Key member to develop product strategy and local commercial team with brand team.
• Provide Japan position on global/region disease and product related programs.
• Provide medical affair consideration on portfolio evaluation and discussion.
• Lead evidence generation and publication plan and execution.
• Implement various scientific programs in collaboration with internal stakeholders such as the Commercial or R&D.

Key responsibility

• Identify, develop, and maintain collaborative relationships with current and future OLs, scientific experts, cooperative study groups, and study sites.
• Partner with the brand team in the development and execution of the local product lifecycle management plan.
• Lead and develop the local medical strategy and activities for the product(s) in accordance with internal and external regulations.
• Provide TA and/or product-specific medical training.
• Ensure consistency of medical content and scientific messages across various tools and materials.
• Visit selected KOLs and study groups for strategic discussions and protocol development.
• Develop study protocols for local Amgen-sponsored studies (AST); support and execute local study protocol preparation, filing, review, and approval in line with Amgen processes and policies.
• Work with GSO to ensure preparation, implementation, and completion of ASTs.
• Support GSO in participation and completion of global/region studies in the country.
• Review local ISS proposals prior to approval and ensure appropriate local/region/global committee review, if applicable.
• Provide input into site selection for ASTs.
• Oversee in-sourced/outsourced medical programs and logistics.
• Participate in or conduct local advisory board meetings, investigator meetings, and/or expert panels.
• Provide medical expertise for products and health economy and reimbursement requests.

Basic Qualifications (Minimum Qualifications)

• Master’s degree.
• Minimum of 2 years in pharmaceutical industry or proven industry collaboration in academia.
• Oncology area knowledge and experience.
• Experience in medical department or clinical development.
• Experience with clinical study management and conduct.
• Knowledge of commercialization and business practices.
• Fluent in Japanese and English.

Preferred Qualifications

• MD, PharmD, or PhD is preferred.
• Knowledge of pharmaceutical product development, product lifecycle, and commercialization process with advanced understanding of other functions including clinical operations, commercial, regulatory, and medical affairs.
• Network of customer contacts in the therapeutic area.
• Finance and budgeting experience.

Competencies

• Medical and scientific expertise.
• Fluency in English, both oral and written communication skills.
• Strong communication and presentation skills.
• Continuously expanding medical, scientific, and market knowledge.
• Strong clinical research knowledge (study design, study evaluation, medical writing skills, expert panel conduct, symposium and workshop management, KOL management).
• Strong customer orientation; science-based.
• Ability to work in a cross-functional team (e.g., commercial, clinical development, health economics, regulatory, safety).
• Role model for others in line with Amgen values.
• Demonstrates leadership skills.