15 Sep
|
NexusHire Solutions
|
New South Wales
15 Sep
NexusHire Solutions
New South Wales
Job Description
Operational Strategy Manager / Senior Manager - Clinical Research
n
Location: Australia - Multiple locations available
n
Employment: Permanent
n
The Opportunity
n
Our client is an established international clinical research organisation supporting biotechnology and pharmaceutical companies with the development and execution of clinical programmes globally.
n
The organisation is seeking an experienced Operational Strategy Manager / Senior Manager to support the development of clinical trial strategies for new business opportunities, with a particular focus on Oncology.
n
Unlike a traditional clinical project management position, this role sits predominantly at the pre-award and proposal stage. You will assess study requirements, feasibility intelligence and operational considerations to determine how a clinical programme can realistically and competitively be delivered.
n
You will work closely with commercial and clinical stakeholders to develop the operational solution presented to prospective sponsors and will participate directly in sponsor discussions and proposal presentations.
n
The Role
n
You will provide operational leadership during the development of recent clinical research opportunities.
n
Taking a Protocol Or Sponsor Requirement As The Starting Point, You Will Evaluate The Operational Implications Of The Study And Develop a Practical Execution Strategy Covering Areas Such As
n
n
Country and site strategy
n
Patient recruitment
n
Study start-up
n
Feasibility
n
Timelines and resources
n
Operational risks
n
Budget assumptions
n
Overall study delivery approach
n
n
You will then translate these considerations into a clear proposal strategy and help communicate and defend the recommended approach with prospective sponsors.
n
Key Responsibilities
n
n
Develop operational strategies for prospective clinical studies based on protocol requirements, sponsor objectives and available feasibility intelligence.
n
Evaluate potential countries, sites and recruitment approaches to determine appropriate study delivery models.
n
Analyse feasibility information,
enrolment projections, start-up timelines and resource requirements.
n
Translate clinical and operational data into practical recommendations for study execution.
n
Develop the operational components of clinical trial proposals and supporting presentation materials.
n
Participate in sponsor discussions, proposal presentations and bid defence activities.
n
Explain and defend proposed operational approaches while responding to sponsor questions and challenges.
n
Identify execution risks, dependencies and potential constraints during the proposal stage and recommend appropriate mitigation strategies.
n
Balance operational feasibility against timelines, cost and commercial competitiveness.
n
Review study budgets, resource assumptions and operational inputs to ensure they support the proposed execution strategy.
n
Work with financial and commercial stakeholders to resolve inconsistencies between study requirements, operational assumptions and proposed budgets.
n
Partner with feasibility, clinical operations, medical, finance, commercial and regional teams to build integrated solutions.
n
Maintain alignment between study assumptions, timelines, risks, budgets and proposed delivery plans.
n
Support the transition of successful proposals into delivery by ensuring key assumptions, commitments and risks are clearly transferred to operational teams.
n
Use benchmarking, feasibility, market and historical operational information to strengthen recommendations.
n
Contribute to the improvement of operational strategy frameworks, proposal processes and planning methodologies.
n
Capture lessons from previous proposals and study opportunities to improve the quality and competitiveness of future solutions.
n
n
What We Are Looking For
n
This role requires someone who understands how clinical trials are actually delivered, but who can apply that knowledge strategically before a study has been awarded.
n
The successful candidate should be comfortable analysing incomplete or complex information, developing a recommended operational approach and presenting the rationale behind that recommendation to both internal stakeholders and prospective sponsors.
n
Key Requirements Include
n
n
Bachelor's degree in Life Sciences, Clinical Research, Healthcare, Business or another relevant discipline.
n
Minimum 7 years' relevant experience across clinical research operations, feasibility, operational strategy, proposal development or related areas.
n
Strong understanding of clinical trial operations and study delivery.
n
Good knowledge of study feasibility, site selection, country strategy, study start-up and patient recruitment considerations.
n
Broad Oncology clinical research experience across multiple indications.
n
Experience developing clinical study strategies, execution plans and/or operational components of proposals.
n
Ability to interpret complex clinical and operational information and convert it into actionable recommendations.
n
Strong cross-functional stakeholder management and influencing skills.
n
Strong written communication, presentation and sponsor-facing capability.
n
Ability to manage multiple proposals and priorities simultaneously.
n
Experience providing technical guidance, coaching or mentoring to colleagues.
n
Ability to travel domestically and internationally when required.
n
n
Highly Desirable
n
n
Previous experience supporting global clinical trial proposals.
n
Participation in sponsor presentations and/or bid defence meetings.
n
Experience reviewing clinical study budgets, resource models and operational assumptions.
n
Exposure to commercial strategy, pricing or financial modelling within a CRO or clinical research environment.
n
Experience working within international, matrixed clinical research teams.
n
📌 (Snr) Operational Strategy Manager, Australia (New South Wales)
🏢 NexusHire Solutions
📍 New South Wales