Senior Manager& Clinical Trial Strategy & Feasibility

NexusHire Solutions

Sydney

On-site

AUD 180,000 - 240,000

Full time

5 days ago
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Job summary

NexusHire Solutions in Australia is seeking an experienced Senior Manager to lead the development of clinical trial strategies at the pre-award and proposal stage, with a strong focus on oncology. The role combines strategic planning with sponsor-facing presentations to defend operational approaches.

You will evaluate country/site strategies, recruitment plans, start-up timelines and budgets, translating insights into clear, competitive proposals for prospective sponsors and partners.

Qualifications

  • Bachelor's degree in Life Sciences, Clinical Research, Healthcare or related field.
  • Minimum 7+ years in clinical research operations, feasibility, or proposal development.
  • Strong understanding of clinical trial operations and oncology delivery.
  • Experience developing study strategies and operational components of proposals.
  • Ability to interpret complex data and present actionable recommendations.

Responsibilities

  • 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 mitigation strategies.
  • Balance operational feasibility against timelines, cost and commercial competitiveness.
  • Review study budgets, resource assumptions and operational inputs to ensure support for the proposed delivery plans.
  • Work with financial and commercial stakeholders to resolve inconsistencies between study requirements 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 transferring assumptions and risks to operations teams.
  • Use benchmarking, feasibility, market and historical data to strengthen recommendations.
  • Contribute to the improvement of proposal processes and planning methodologies.

Skills

Feasibility analysis
Oncology knowledge
Proposal development
Cross-functional management
Sponsor-facing capability
Budget understanding
Study start-up
Site selection
Country strategy
Multi-project management
Presentation skills
Mentoring/coaching

Education

Bachelor's degree in Life Sciences or related

Job description

Senior Manager, Clinical Trial Strategy & Feasibility

Location: Australia – Multiple locations available
Employment: Permanent

The Opportunity

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 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.

The Role

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.

Key Responsibilities
  • 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.
What We Are Looking For

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.
Highly Desirable
  • 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.

. Skillset Required: Clinical trial strategy, Feasibility analysis, Clinical research operations, Proposal development, Clinical trial operations, Study delivery, Study feasibility, Site selection, Country strategy, Study start-up, Patient recruitment, Oncology clinical research, Clinical study strategies, Execution plans, Operational proposals, Cross-functional stakeholder management, Influencing skills, Written communication, Presentation skills, Sponsor-facing capability, Multi-project management, Technical guidance, Coaching, Mentoring, Domestic travel, International travel, Global clinical trial proposals, Sponsor presentations, Bid defence, Clinical study budgets review, Resource modeling, Operational assumptions, Commercial strategy, Pricing, Financial modeling, Matrixed team collaboration

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