Associate Director, Clinical Scientist

The Role:

Join Moderna Therapeutics enthusiastic and collaborative team and make a significant impact on the overall success of our novel messenger RNA approach to drug development.

Moderna is seeking an Associate Director, Clinical Scientist to develop the clinical development strategy and execute activities to support its RSV vaccine portfolio. The Associate Director, Clinical Scientist is responsible for performing core clinical development activities in partnership with the Clinical Development team with responsibilities to include clinical trial design, protocol development, Sponsor medical monitoring, review of and contribution to interpretation of clinical trial data, and timely execution of deliverables in close collaboration with relevant internal and external partners

Industry experience, preferably within vaccine development is a plus, but not required. This role will report to Modernas Senior Director of Clinical Development for RSV Older Adults, under the Infectious Diseases Therapeutic Area. It will support driving the strategic development and execution of Clinical Development Plans for RSV vaccines. The position is based at Moderna headquarters in Cambridge, or in one of our HUB locations in NJ/PA or MD.

The successful candidate is driven, curious, collaborative, with a bold ambition to contribute to the development of ground-breaking mRNA-based vaccines. The candidate must have excellent oral and written communication skills and a collaborative mindset.

Heres What Youll Do:

• Work as part of an integrated clinical development team for individual studies and programs at the trial and project team level.

• Contributing to key strategic documents including clinical development plans, protocol concepts and full protocols for product(s).

• Contributing to the development of clinical sections of regulatory documents such as Investigators Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions, and contribute to Clinical Development Plans.

• Reviewing and summarizing relevant literature on the clinical development programs.

• Performing medical data/safety review during study execution to ensure integrity of accruing study data and appropriate safety follow-up.

• Set up and management of investigator initiated clinical and/or pre-clinical trials.

• Develop effective working relationship with key investigators in assigned programs to optimize scientific quality/innovation of clinical study design, execution, reporting and publication.

• Support or lead investigators meetings and protocol training meetings.

• The Clinical Scientist is responsible for analyzing and interpreting study data from an individual study and translating study level clinical data across the program of studies for a particular drug, ensuring that all studies are conducted with the highest level of ethical and safety standards and are in compliance with GCP and all regulatory policies.

• Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic and biomarker data, to provide consolidated information.

• Providing support to advisory boards, steering committee meetings, consultant meetings and investigator meetings, including preparation and delivery of presentations.

• Proactively seeking out and recommending process improvements.

• Providing scientific input to the preclinical team for translational studies of interest including biomarker development strategies.

• Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.

• Author/review abstracts, presentations, and manuscripts for external publications.

• Develop and maintain strong, collaborative relationships with the broader Moderna organization.

Heres What Youll Bring to the Table:

• Masters Degree, PhD, PharmD, or M.D. with clinical trial/drug development Phase 1-3 expertise highly desirable.

• Proven ability to plan and conduct clinical trial, and deliver high-quality results within established timelines

• Experience on a previous Phase 2/3 development program is highly desirable

• Demonstrated track record in leading cross-functional teams and work streams (pharmacovigilance, biostatistics, clinical operations, and regulatory affairs).

• Creative problem-solver with ability to thrive in a fast-paced environment.

• Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals.

• Excellent analytical, problem-solving and strategic planning skills.

• Strong interpersonal skills commensurate with the need to work closely with CROs, investigators, consultants, and Moderna team members across functions in a matrix environment.

• Exceptional written and oral communication skills to meet the needs of varied audiences.

• Integrated understanding of global regulatory authorities, ICH GCP, and GPP/GEP guidelines. Prior interaction with major public health agencies is preferred.

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 winter shut down
  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 persons 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.

-