This role will support early/late phase Rare Disease Therapies specifically supporting the Study Physician/s executing phase 1-3 studies. As part of the role, the Clinical Scientist will:
Support the Study Physician/s and cross-functional study management teams 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 driving 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 regulatory activities as required
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
Conduct literature reviews as needed
Heres What Youll 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.
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 Rare Disease 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 biostatistics, GCP, data integrity, exploration, analysis, regulatory requirements for clinical studies and presentation
Ability to handle multiple projects simultaneously
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.
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!
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
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 email@example.com. (EEO/AAP Employer)