(Snr) Operational Strategy Manager, Australia
Job Summary
Location: Australia – Multiple locations available
Employment: Permanent
Our client is an established international clinical research organisation supporting biotechnology and pharmaceutical companies with the development and execution of clinical programmes globally.
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.
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.
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.
You will provide operational leadership during the development of new clinical research opportunities.
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:
- Country and site strategy
- Patient recruitment
- Study start-up
- Feasibility
- Timelines and resources
- Operational risks
- Budget assumptions
- Overall study delivery approach
You will then translate these considerations into a clear proposal strategy and help communicate and defend the recommended approach with prospective sponsors.
- Develop operational strategies for prospective clinical studies based on protocol requirements sponsor objectives and available feasibility intelligence.
- Evaluate potential countries sites and recruitment approaches to determine appropriate study delivery models.
- Analyse feasibility information enrolment projections start-up timelines and resource requirements.
- Translate clinical and operational data into practical recommendations for study execution.
- Develop the operational components of clinical trial proposals and supporting presentation materials.
- Participate in sponsor discussions proposal presentations and bid defence activities.
- Explain and defend proposed operational approaches while responding to sponsor questions and challenges.
- Identify execution risks dependencies and potential constraints during the proposal stage and recommend appropriate mitigation strategies.
- Balance operational feasibility against timelines cost and commercial competitiveness.
- Review study budgets resource assumptions and operational inputs to ensure they support the proposed execution strategy.
- Work with financial and commercial stakeholders to resolve inconsistencies between study requirements operational assumptions and proposed budgets.
- Partner with feasibility clinical operations medical finance commercial and regional teams to build integrated solutions.
- Maintain alignment between study assumptions timelines risks budgets and proposed delivery plans.
- Support the transition of successful proposals into delivery by ensuring key assumptions commitments and risks are clearly transferred to operational teams.
- Use benchmarking feasibility market and historical operational information to strengthen recommendations.
- Contribute to the improvement of operational strategy frameworks proposal processes and planning methodologies.
- Capture lessons from previous proposals and study opportunities to improve the quality and competitiveness of future solutions.
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.
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.
Key requirements include:
- Bachelor's degree in Life Sciences Clinical Research Healthcare Business or another relevant discipline.
- Minimum 7 years' relevant experience across clinical research operations feasibility operational strategy proposal development or related areas.
- Strong understanding of clinical trial operations and study delivery.
- Good knowledge of study feasibility site selection country strategy study start-up and patient recruitment considerations.
- Broad Oncology clinical research experience across multiple indications.
- Experience developing clinical study strategies execution plans and/or operational components of proposals.
- Ability to interpret complex clinical and operational information and convert it into actionable recommendations.
- Strong cross-functional stakeholder management and influencing skills.
- Strong written communication presentation and sponsor-facing capability.
- Ability to manage multiple proposals and priorities simultaneously.
- Experience providing technical guidance coaching or mentoring to colleagues.
- Ability to travel domestically and internationally when required.
- Previous experience supporting global clinical trial proposals.
- Participation in sponsor presentations and/or bid defence meetings.
- Experience reviewing clinical study budgets resource models and operational assumptions.
- Exposure to commercial strategy pricing or financial modelling within a CRO or clinical research environment.
- Experience working within international matrixed clinical research teams.