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About the Role

The Senior Operational Strategy Manager 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 to develop differentiated, clinically grounded strategies that optimise speed, quality, and regulatory success, combining deep understanding of early phase delivery models with strong commercial and operational acumen.

Responsibilities

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.
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.
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.
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.
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-offs.
Act as a subject matter expert in early phase operational strategy, including HV models, site partnerships, and fast-start study execution.

Requirements

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.
Must have full unrestricted working rights in Australia.
Cannot provide sponsorship for this role.

Skills

Operational strategy
Early phase delivery models
Healthy volunteer and targeted patient populations
Commercial acumen
Operational acumen
Bid defence preparation
Scenario modelling
Risk identification and mitigation
Process governance
Quality governance
Data-driven insights
Mentoring junior strategists

Location

Australia

Work Type

Hybrid working arrangements
Full flexibility in working hours

Experience Level

Senior

Benefits

Flexible working options
Paid parental leave for both parents
Flexible leave entitlements
Wellness programs
Ongoing development programs

About the Company

Novotech is a global full-service clinical Contract Research Organization (CRO).
Novotech is a globally recognized leader in clinical research and scientific advisory services.
Award-winning workplace culture that values ambition, innovation, and growth.
Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE).
Fostering an environment that reflects the life-changing work we do.
Expanded global footprint with 30+ offices across Asia-Pacific, the United States, and Europe.
Uniting professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
Employees are at the heart of our success.
Offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework.
Empowering team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
Access to mentorship opportunities, professional development programs, and a dynamic community.
Platform for driven individuals to achieve personal growth while shaping the future of healthcare.
Advanced therapeutic and regulatory expertise.
Ability to execute across markets.
Client-centric service model.
Trusted, long-term partner and an accelerated path to bring life-changing advances to market.
Opportunity to develop careers by joining a diverse and supportive global organization with a collaborative culture.
Working with clients on the cutting-edge of life sciences.
Empowered teams with a shared commitment to success.
Culture that fosters partnership and collaboration, where every voice is heard and valued.
Ongoing support from senior stakeholders and leadership team.

Equal Opportunity

Committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
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.
Circle Back Initiative Employer and commit to respond to every application.