Head of Clinical Development - Remote
Company: Genesis Care Pty Ltd
Location: Fort Myers
Posted on: August 5, 2022
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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.
Keywords: Genesis Care Pty Ltd, Fort Myers , Head of Clinical Development - Remote, Healthcare , Fort Myers, Florida
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