The Senior Clinical Scientist will support early/late phase Oncology Vaccine programs, specifically supporting the Study Physician executing phase 1-3 studies.
Here's What You'll Do:
- Support the Study Physician in the oversight of clinical studies including review and interpretation of clinical trial data and timely execution of deliverables in collaboration with relevant internal and external partners.
- Support the Study Physician, the Clinical Scientist assists in the preparation of protocol writing, informed consents, and other protocol-related documents for the operational execution of clinical studies.
- Participate in the start-up of global clinical studies, working with Clinical Operations to ensure on schedule site activation and subject enrollment, monitoring, compliance with department safety practices, policies, procedures as well as the day-to-day management of a clinical trial Implement clinical study parameters, deliverables, policy compliance and resource needs, apply scientific discipline to minimize risk and increase performance.
- Plays a key role in the review of study data to ensure timely and high-quality data entry, including review of case report forms, assists in coding, analysis, and proper and complete documentation of clinical data.
- Participate in investigator meetings, investigator engagement, including assisting in the preparation of Advisory Board meetings.
- Supports Study Physician and Pharmacovigilance in managing sites to ensure study treatment discontinuation or other safety decisions are made per protocol and align with stakeholders within the study team.
- Supports the Study Physician to coordinate relevant and timely data analyses and presentations in collaboration with safety, data management, Data Monitoring Committee, Biostatistics, Pharmacometrics and Biomarker teams to meet timelines for safety monitoring committee meetings, regulatory documents and to internal reviews to make timely program decisions regarding study objectives.
- Participate in the training of site and Company staff on the study protocol, ensure the clinical staff have the necessary guidance and tools for performance of various projects.
Here's What You'll Bring to the Table:
- High-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to early disease clinical research and the highest personal and ethical standards.
- Must be equally comfortable among the team to which he/she is assigned and in the global environment in which the Company operates.
- Require capabilities to work on additional studies moving into operation in later years. This will involve close interaction and working closely with the discovery, biomarkers, clinical pharmacology, pharmacometrics, regulatory, biostatistics, clinical operations and Clinical Development.
- Understanding how these various functions work, the Clinical Scientist should be capable of implementing translational medicine approaches for clinical development.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Advanced Degree in a Scientific discipline (i.e. M.S, Ph.D. or Pharm.D. or equivalent work experience) is required.
- A minimum of 5 years of clinical research and development, or related experience within the industry (pharmaceutical, biotech, CRO, etc.) is preferred.
- Experience in Oncology development.
- Significant experience with clinical evaluation projects including development of protocols, case report forms, informed consent and study initiation and monitoring preferred.
- Significant experience with data integrity, exploration, analysis and presentation
- Excellent written communication, oral communication, and presentation skills are required.
- The individual must have demonstrated ability to work in a team environment.
- Ability to travel up to 15% required.
- 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.