Therapeutic Area Lead

gulatory portals

• Assisting Affiliate/Sub-Regional Medical Advisors in interactions and communication with external customers, key organizations, and institutions

• Assessing risk and identifying issues, conflicts or gaps (Affiliate/Sub-Regional) across the portfolio

• Hiring, coaching, mentoring and developing staff and team members

• Ensuring Affiliate/Sub-Regional TA goal accountability

• Provide leadership and strategic direction to the Affiliate/Sub-Regional TA staff

• Assist the IML 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/Sub-Regional TA plans, goals, proposals and deliverables, including but not limited to protocols and SAP's for local AST's

• Chairs Affiliate/Sub-Regional TA 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 IRD and Affiliate/Sub-Regional Management

• Partner with the Affiliate/Sub-Regional Business Unit for all product lifecycle management activities

• Provide input, review, approve the Affiliate/Sub-Regional lifecycle management plan and ensure alignment across the portfolio

• Provide scientific/clinical oversight for the compilation of regulatory submissions across the portfolio

• Chairs the Local Development Team (LDT)

• Member of the International Development Team (IDT)

• Extended member of the International Business Team (IBT)

• Provide clinical oversight of product safety evaluation within the Affiliate/Sub-Regional TA

• Provide support and leadership for advisory boards

• Set Affiliate/Sub-Regional TA goals and dashboards to evaluate performance

• Ensure adequate resources and budget across all programs (study and non-study) and maintain budget accountability

Authority

Direction, activities, and resource allocation within Affiliate/Sub-Regional TA

Integrated portfolio evidence generation and communication plan

Clinical content of Local regulatory agency briefing documents, submissions, and interactions (portfolio level)

Clinical content of Local documents, submissions and interactions with all statutory agencies

Sign-off at signature authority level

Outputs

Affiliate/Sub-Regional TA lifecycle management plans and medical sections of regulatory documents

Affiliate/Sub-Regional TA goals, objectives, and performance metrics

Sr. Management portfolio status reports and dashboards

Sub-Regional TA budget

Minimum Requirements

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

Preferred Requirements

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

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