Operational Strategy Manager

Operational Strategy Manager – Early Clinical Development (ECD)

About the role

The Operational Strategy Manager (ECD) leads operational strategy for complex early phase programmes, including First-in-Human (FIH), SAD/MAD, proof-of-mechanism, and early patient studies. This role drives cross-functional alignment across BD, Clinical, Medical, Translational Sciences, and Finance to develop differentiated, clinically grounded strategies that optimise speed, quality, and regulatory success.

The role combines deep understanding of early phase delivery models (including healthy volunteer and targeted patient populations) with strong commercial and operational acumen. The Senior Manager mentors junior strategists, supports bid defence preparation, and ensures high-quality, consistent ECD strategy across major pursuits.

What you will do:

ECD Strategy Leadership

• Own operational strategy for complex early phase opportunities (FIH, HV, patient cohorts, adaptive designs).
• Develop compelling, clinically informed narratives that differentiate Novotech’s ECD model, including site partnerships, speed-to-dose, and quality execution.
• Lead alignment across BD, Clinical Operations, Medical, Translational, and Finance to ensure integrated delivery strategies.
• Support executive-level reviews and bid defences with clear, evidence-based positioning.

Early Phase Budgeting & Scenario Modelling

• Interpret complex early phase cost drivers (e.g., HV recruitment, bed capacity, dose escalation timelines, biomarker sampling).
• Build scenario models comparing delivery options (HV vs patient, single-site vs multi-site, ANZ vs global).
• Identify operational, regulatory, and commercial risks specific to early phase studies and define mitigation strategies.
• Ensure delivery models are realistic, scalable, and aligned to ECD timelines and competitive positioning.

Process & Quality Governance (ECD)

• Ensure all ECD strategy materials meet internal quality standards and external expectations.
• Apply consistent frameworks for early phase study design, feasibility, and execution planning.
• Maintain audit-ready documentation aligned to regulatory expectations for early phase trials.
• Support post-win handoff with clear operational plans for FIH readiness and study start-up.

Systems, Tools & Data-Driven Insights

• Use advanced tools to model early phase timelines, site capacity (including HV beds), staffing, and cost drivers.
• Maintain accurate and complete strategy documentation across complex ECD proposals.
• Support adoption of ECD-specific templates, modelling tools, and datasets.
• Ensure data integrity and consistency across all early phase strategy outputs.

Cross-Functional Leadership & ECD SME Role

• Lead cross-functional discussions to resolve operational challenges specific to early phase delivery.
• Mentor junior strategists in early clinical development strategy and modelling approaches.
• Communicate clearly with internal stakeholders and leadership on ECD risks, assumptions, and trade[1]offs.
• Act as a subject matter expert in early phase operational strategy, including HV models, site partnerships, and fast-start study execution.

What you must have:

• 5–8 years of experience in clinical operations, early clinical development, strategy, or related fields.
• Demonstrated experience supporting early phase (FIH, HV, or Phase I/IIa) studies.
• Strong analytical, scenario modelling, and narrative development skills.
• Ability to influence cross-functional stakeholders and drive alignment in complex programmes.
• Excellent written and verbal communication skills.

Preferred:

• Experience with healthy volunteer (HV) studies, including site models and capacity considerations.
• Exposure to translational science, biomarkers, or dose-escalation strategies.
• Experience with commercial strategy, pricing, or bid defense for early phase programmes.
• Experience mentoring or coaching junior team members

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. 

Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
 

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
 

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.