Posted: 7 March 2023
The Role:
This exciting opportunity will provide Clinical Pharmacology leadership into global R&D programs, will be a key regional R&D liaison in early clinical development activities and regulatory interactions, and will support the growth of Moderna’s Regional R&D Centre in Melbourne.
The candidate must thrive in a fast pace environment with high expectations. Integrity, ability to share experimental issues and troubleshoot, curiosity, collaborative spirit, respect for people, exemplary work ethic and setting the bar high are key values to thrive in our Team.
Here’s What You Will Do
- Develop and execute the Clinical Pharmacology strategy on assigned program(s) and represent clinical pharmacology function on project teams through all stages spanning from early development (pre-IND) through late stage-development (Phase 3, filings worldwide, and lifecycle management)
- Be responsible for clinical pharmacology summary documents (such as IB, BB, CTA, CTD Module 2 documents, product labeling, etc.).
- Be responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in collaboration with key partner functions (e.g., Pharmacometrics, QSP and DMPK). Ensures that M&S plans are fully integrated with the overall clinical pharmacology plans to enable Model-Informed Drug Development (MIDD).
- Work closely with colleagues in Pharmacometrics/QSP to ensure strategic integration of advanced modeling and simulation approaches (e.g., QSP, MBMA) across the development continuum to inform internal decisions and external regulatory interactions.
- Mentor junior staff and research fellows as needed
- Will apply experience in FIH dose determination, dosing schedule and clinical trial design, regulatory considerations in execution of clinical PK/PD studies in different patient populations
- Will apply experience in participation on regulatory agency meetings
- Will use strong data analysis skills and an in-depth knowledge of population pharmacokinetic and pharmacodynamic principles, including their interpretation and integration with safety and efficacy data to ensure appropriate dosing regimen decisions are made
- Apply thorough understanding of clinical biomarkers and pharmacogenomics applications to clinical trial design and patient outcomes
- Understand and apply the highest ethical standards in clinical trial research
- Apply comprehensive understanding of clinical regulatory requirements and knowledgeable in ICH and GCP guidelines to clinical trial design and conduct
- Produce and present quality scientific presentations at internal or external meetings
- Apply excellent verbal and written communication and presentation skills
- Will work effectively in a matrix, team environment, manage multiple priorities and exercise sound judgment
- Will apply substantial experience in establishing and managing R&D partnership initiatives with demonstrated ability to provide strategic level advice and commercial thinking in relation to these opportunities
- Support the Director of the Regional mRNA R&D Centre in the establishment and execution of the R&D Center in Melbourne including areas such as the:
- Development of long-term R&D plans and subsequent annual R&D operational plans in alignment with the global R&D strategy and considering the Australian market landscape
- Undertaking and maintenance of a detailed mapping of Australia’s mRNA R&D ecosystem to identify areas of engagement and investment for Moderna
- Maintenance of strong connections with Moderna’s Global R&D organization – especially in Clinical Pharmacology, Quantitative Pharmacology and Translational Medicine – to understand the priority areas for R&D prioritization and align this with external opportunities within Australia
- Representation of Moderna to the Australian R&D ecosystem, forging strong relationships with academia and the broader R&D industry
- Identification of opportunities for investment across areas such as: Research Collaborations, Joint Ventures, Clinical Trials, Technology Licensing, and Industry Development programs
Here’s What You’ll Bring to the Table
- MBBS/MD/PharmD/Ph.D. with 11+ years of proven experience in clinical pharmacology in biotech and/or pharmaceutical industry.
- Strong understanding of technical aspects and standard methodologies in Clinical Pharmacology and Pharmacometrics, experience in designing and executing clinical pharmacology studies, and a demonstrated ability to make data-driven decisions based on preclinical and clinical data.
- Experience leading clinical pharmacology aspects of programs at all stages of development and experience with writing and defending the clinical pharmacology sections of an NDA/BLA is strongly preferred.
- Substantial experience in influencing complex groups of internal and external stakeholders to develop and manage major research and/or engagement partnership initiatives with demonstrated ability to provide strategic level advice and commercial thinking in relation to these opportunities.
- Proven exceptional interpersonal and verbal communication skills, with the ability to work effectively in a high performing team and to quickly establish rapport and manage collaborative working relationships with people from diverse backgrounds, disciplines and levels across academia and external public or private sector organisations
- Outstanding communication, influencing and negotiation skills
- Strong project management experience in a complex environment with competing priorities, including demonstrated ability to manage workflows, undertake multiple complex projects simultaneously and meet deadlines
- Personify Moderna’s values of being Bold, Curious, Collaborative and Relentless
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
- Quality healthcare and insurance benefits
- Lifestyle Spending Accounts to create your own pathway to well-being
- Free premium access to fitness, nutrition, and mindfulness classes
- Family planning and adoption benefits
- Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
- Educational resources
- Savings and investments
- Location-specific perks and extras!
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
