Global Development Leader
Job Description
The Global Development Lead (GDL) will be responsible for driving the current Cardio-Metabolic program forward. The GDL will work collaboratively with Arrowhead’s Senior Leadership Team to strategize a path forward toward commercialization. The GDL is accountable for the overall drug development, design, implementation, and execution of the Cardio-Metabolic programs which will support decision milestones, regulatory requirements, feasibility, and operational planning, with particular emphasis on regulatory interactions. The GDL will have strong product knowledge and will lead all regulatory strategic planning, and delivery of the Cardio-Metabolic programs and studies. The GDL will ensure the successful delivery of regulatory submissions and deliverables.
Responsibilities
- Lead the development and execution of the clinical strategy
- Accountable for oversight of all clinical operations activities within the Cardio-Metabolic therapeutic area; ensure relevant issues are escalated as appropriate and provision of clinical operations expertise/input into the programs (e.g. feasibility, country selection, operational input into design, risk and external partner management) using new innovative design and strategy to support regulatory interactions and project completion
- Responsible for defining clinical and regulatory strategy in leading discussions with the FDA and/or EU regulatory agencies;
- Engagement with cross functional teams to ensure proper design and delivery of clinical development plans.
- Effectively partners cross functional heads to provide leadership, clear direction and aligned goals to the clinical operations teams.
- Make scientific presentations at advisory boards, key scientific meetings and external committee meetings.
- Contribute to document finalization; including IRB submissions, protocols, CSRs, publications and regulatory submissions.
- Accountable for ensuring strong team structure and high team performance.
- Accountable for the line management of Clinical operational leaders.
- Responsible for the delivery of the clinical derived deliverables of regulatory submissions, providing input for regulatory interactions and reports as well as inspection readiness.
- Is the initial and program-level operational interface with external partners and collaboration/alliance partners for program planning and delivery.
- Line management of the Cardio-Metabolic team members.
- Establish collaborative, effective, and trusting relationships with key internal functions and leadership including commercial, R&D, legal, and finance to ensure the free flow of information and ideas.
- Report to Chief Medical Officer.
- May act as a medical monitor, including evaluation of the safety, pharmacology and efficacy in ongoing and completed studies in collaboration with drug safety and clinical operations.
- Maintain clinical and scientific awareness in the area of expertise.
- MD degree with a minimum of 15 years clinical research experience within a biopharmaceutical company; to include a minimum of 5 yrs clinical practice.
- Experience in drug development, business development, and/or pipeline strategy in the pharmaceutical or biotech industry;
- Comprehensive experience in cardio-metabolic treatment
- Able to create strategic plans, lead development and execute complex plans across multiple priorities;
- Experience in interacting with the FDA and/or EU regulatory agencies; and regulatory filing.
- Experience with cardiovascular outcomes trials.
- Conflict management and resolution
- Drive clarity and results oriented
- Subspecialty board certification in cardiology
Date Posted
03/11/2023
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1
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