Auto req 12887BR
Job Posting Title Therapeutic Area Lead - Haematology/Oncology
Career Category Medical Affairs
Employee Subgroup Salaried FT
Country (State/Region) Australia
Location (City) Sydney
Amgen Job Description Based in Sydney, Australia.
Full time permanent role, reporting to:
Affiliate Medical Director (Direct)
International TA Head (Indirect)
Responsible for:
- Being the single point of accountability for all Affiliate TA activities
- Driving the data generation, establishing and communicating the strategy for the Affiliate TA
- Developing goals and tactics for the Affiliate TA
- Managing resources and budget for the Affiliate TA; forecast accuracy within area of responsibility
- Directing Affiliate Medical Advisors in navigating products through internal governance and external regulatory portals
- Assisting Affiliate Medical Advisors in interactions and communication with external customers, key organizations, and institutions
- Assessing risk and identifying issues, conflicts or gaps across the portfolio
- Hiring, coaching, mentoring and developing staff and team members
- Ensuring Affiliate TA goal accountability
Key Activities:
- Provide leadership and strategic direction to the Affiliate TA staff
- Assist the International Medical Lead in identifying and resolving clinical/scientific issues
- Perform portfolio level risk assessments and prioritization of programs
- Ensure alignment of early-stage strategy with late-stage TA objectives
- Approve Affiliate TA plans, goals, proposals and deliverables, including but not limited to protocols and SOPs for local Amgen Sponsored Trials.
- Chairs AffiliateTA Team meeting
- Foster and improve International collaboration and coordination
- Serve as a key interface to communicate Internationally and Locally important issues and status of programs to Amgen International Research & Development and Affiliate Management
- Partner with the Affiliate Business Unit for all product lifecycle management activities
- Provide input, review, approve the Affiliate lifecycle management plan and ensure alignment across the portfolio
- Provide scientific/clinical oversight for the compilation of regulatory submissions across the portfolio
- Member of the International Development Team (IDT)*
- Member of the International Business Team (IBT)*
- Provide clinical oversight of product safety evaluation within the AffiliateTA
- Provide support and leadership for advisory boards
- Set Affiliate TA goals and dashboards to evaluate performance
- Ensure adequate resources and budget across all programs (study and non-study) and maintain budget accountability
Basic Qualifications Qualifications:
- Medical Degree (MD)
Experience:
- 6 or more years of clinical development experience, 4 years of which should be from a pharmaceutical or biotechnology company
- Clinical research experience
- Broad and formal leadership experience
Knowledge:
- In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
- In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials
- Medical knowledge in the relevant therapeutic area
- Sound scientific and clinical judgment
- Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups
- Knowledge of Good Clinical Practices (GCP), EMEA regulations and guidelines, and applicable international regulatory requirements
- Understanding of new drug commercialization and business practices
- Understanding of resourcing and budgeting
- Proven ability to lead, manage, and motivate others in a complex, multi-functional, multi-national matrix environment
- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
- Demonstrated ability to organize and lead expert Clinical Research Advisory Panels
- History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
Note: Applicants should have work rights in Australia to be considered for this role.
Preferred Qualifications Preferred requirements:
- Post-graduate qualifications in Oncology.
- Industry experience in the Oncology area, with a network of KOL's.
