Director, Clinical Pharmacology Leader

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 Modernas 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.

Heres What Youll 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

• Maintenance of strong connections with Modernas 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

Heres What Youll Need (Minimum Qualifications)

• MBBS/MD/PharmD/Ph.D. in clinical pharmacology in academic, biotech and/or pharmaceutical industry

• 11+ years of experience

Heres What Youll Bring to the Table (Preferred Qualifications)

• 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 Modernas values of being Bold, Curious, Collaborative and Relentless

• Relocation provided as needed

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  Vacation, sick time and holidays
  Volunteer time to participate within your community
  Discretionary year-end shutdown
  Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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