Sr. Medical Advisor | Amgen

Website Amgen

Sr. Medical Advisor | Amgen

Category: Medical Affairs
Job ID: R-101497
Location: Diegem, , BE
Additional Location:
Posted Date: 7/7/2020

Accountabilities

To provide state-of-the-art medical insight into the therapeutic area (TA) and/or specific molecules to Local and International teams​

To serve as a single point of contact for Local and International teams in area of responsibility

Reports (at a minimum) to

•Affiliate TA  Head (Direct)​
•International Medical Leader (Indirect)​

Responsibilities

•Product(s) lifecycle management ​
•Leading and developing the Local Medical strategy and Medical activities for the product(s) in accordance to internal and external regulations​
•TA and/or product specific Medical training ​
•Management of internal and external relationships within area of responsibility​
•Ensuring consistency of Medical content and scientific messages across various tools and materials​
•Works with Local DFO to ensure preparation, implementation and completion of AST’s (Amgen sponsored studies)​
•Develops study protocols and data analysis plans for Local  AST’s; supports and executes Local study protocol preparation, filing, review and approval in line with Amgen processes and policies​
•Supports Local DFO in participation and completion of International development studies in the country​
•Participates in the development of International strategies and tactics in close collaboration with the IML​
•Visits selected KOL’s and study groups for strategic discussions and protocol development​
•Reviews Local ISS proposals prior to approval and ensures appropriate Local review prior to IPRC submission, if applicable​
•Partners with the BU Manager in the development and execution of the Local product(s) lifecycle management plan​
•Provides input into site selection for AST’s ​
•Oversees in-sourced/outsourced Medical programs and logistics​
•Supports Local regulatory and ethics approvals for development protocols ​
•Develops and executes better recruitment strategies in conjunction with Local DFO team​
•Participates in/conducts Local Advisory Board Meetings, Investigator Meetings and/or Expert Panels​
•Provides Medical expertise for pipeline products​
•Provides Medical expertise for Health Economy and reimbursement requests​
•Member of the Local Development Team (LDT)​

Authority

•Signs off Local R&D plan for his/her area of responsibility​
•Approves scientific content of Local symposia/workshops/publications/ promotional materials/medical section of reimbursement files​
•Signs off Direct Outside Expense at signature level​

Outputs

•Brand/disease specific parts of Local R&D plan​
•Local support for Medical questions, feasibility and trial strategy​
•Local Product Lifecycle Plan ​
•Protocols and other study documents for local AST​
•Medical expertise for the review of promotional and scientific documents (e.g. symposia, publications etc.)​
•Local R&D brand/disease related results according to goals and metrics​

Minimum Requirements

•Minimum of 2 years in pharmaceutical industry, or proven industry collaboration in academia ​
•Experience in affiliate Medical Department or Clinical Development​
•Experience with clinical study management and conduct​
•Knowledge of commercialization and business practices​

Preferred Requirements

•Knowledge of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs​
•Therapeutic area knowledge ​
•Network of customer contacts in therapeutic area​
•Finance and budgeting experience​

Competencies

•Medical and scientific expertise​
•Fluency in English, both oral and written communications​
•Strong communication and presentation skills​
•Continuously expanding medical and scientific knowledge as well as 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, Clin Development, EU teams, HE, Regulatory, Safety, etc.)​
•Role model for others in line with Amgen Values​
•Demonstrates leadership skills​

Join Us

If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

To apply for this job please visit bioinformaticsindia.com.