Head of Clinical Development - Remote

Company: Genesis Care Pty Ltd
Location: Fort Myers
Posted on: August 5, 2022

Job Description:

At GenesisCare we want to hear from people who are as passionate as we are about innovation and working together to drive better life outcomes for patients around the world. Head of Clinical Development The role Position: Head of Clinical Development Division: GenesisCare Sponsor Location: United States Status: Full time Role Summary You will be accountable for clinical operations strategy, clinical trial delivery model and performance against key trial metrics and deliverables for assigned programs within GenesisCare (GC). Reporting lines: As the Head of Clinical Development, you will report directly to the Chief Operating Officer. Direct reports may include regulatory, clinical research, and administrative operational staff. Reporting lines and direct reports may change from time to time in line with the requirements of the role. Your key responsibilities: Responsible for the effective oversight of designated personnel and programs, as well as driving departmental goals and initiatives to desired outcomes Hiring, management and development of the research team and assignment of resources to the project teams in line with project budget requirements Directly participates in and has accountability for clinical operations strategy, clinical trial delivery model and performance against key trial metrics and deliverables, which may also include quality, regulatory and finance. Ensures inspection readiness of both active and completed studies and programs. Develops relationships with CRO and vendor partners; Establishes vendor metrics and conducts review in support of quality delivery. Strong collaboration and partnership with cross functional colleagues nationally and globally to ensure on-budget, timely, high-quality delivery of the programs. Ensuring clinical operations strategic and operational input to clinical development programs. Active participation and leadership in clinical operations and cross-functional organizational initiatives to drive improvements in efficiency and operational excellence. Lead the development of procedural documents within the department. Implement and maintain a system to manage quality throughout all stages of clinical development incorporating the principles of Quality by Design. Utilise risk management principles and methodologies in all aspects of clinical development; identify program risks, and together with relevant stakeholders, implement mitigation strategies. Ensure all legal and regulatory responsibilities (i.e. ICH GCP E6, E8, HIPAA) are maintained, even where they have been delegated to a CRO. Create a resourcing strategy to support needs for Oncology clinical programs and activities. Hiring, management and development of the clinical research team and assignment of resources to the project teams in line with project budget requirements. Experience: Excellent verbal, written, and interpersonal skills Proven ability and experience to effectively execute clinical trials within designated program budgets and timelines Demonstrated excellence in complex project management and effectively managing multiple projects/priorities via matrix and/or project-based teams Experience in all aspects of clinical trial management, including implementation of organisational systems and processes for management of clinical trials (e.g. clinical operations, finance, quality assurance, governance systems/SOPs/structures) Experience working in Oncology therapeutic areas highly preferable Strong financial acumen and ability to critically develop, review and track program budgets Track record of building and leading high-functioning teams, both within clinical operations and cross- functionally Qualifications and attributes: Bachelor's degree in a scientific discipline, advanced or professional degree desirable Substantial clinical research experience (at least 10 years) and a consistent track record in clinical product development with complex clinical studies including leading global trials in an outsourced CRO partnership model Experience in successful planning and implementation of clinical trial operations on time, within budget, and in compliance Thorough knowledge and understanding of FDA and EMA Regulations, ICH Guidelines, and GxPs governing the conduct of clinical trials Critical and creative thinker; able to work independently to determine appropriate strategies for resolution of complex problems Other requirements for this role: US based Self-motivated leader, high energy and empathy, influencing capabilities and interpersonally savvy across all levels of the organisation Undertake travel, domestically and internationally, to fulfil the role requirements Your key working relationships: As the Head of Clinical Development, you need to develop strong relationships with the following parties: GC Research & Insights Leadership team Clinicians and KOLs CRO and vendor teams Executive Leadership team Global Partner Services Our purpose Our purpose is to create care experiences that get the best possible life outcomes. Joining the GenesisCare team means a commitment to seeing and doing things differently. Asking what if and why not? And being focused on getting the best possible outcomes for our patients. We are a team of professionals who believe care should be focused on the individual, not the condition. That care should be available when and where people need it most and it should be designed to help give people the best life outcomes possible. We specialise in treating and innovating in cancer and heart disease, the two biggest diseases that impact people's lives. We're proud that we are designing better care for more people around the world every day. #LI-SM1 #LI-Remote GenesisCare is an Equal Opportunity Employer.

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