Director, Clinical Pharmacology

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 Clinical Pharmacology Department.

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

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 organizations

• 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 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!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

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 committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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