The Associate Director, SOP Strategy and Deployment will be responsible for executing the implementation strategy for the Clinical Development organization. This role will work closely with the Director, Training and Process Management, Clinical Compliance and Inspection Readiness team, the Clinical Risk Management Strategy team, and on SOP strategy and deployment to support the organization in being in a proactive state of inspection readiness. The successful candidate will have experience in training, process development and management and SOP strategy. The ability to effectively collaborate and organize in a fast paced and results oriented environment, combined with a passion for Clinical Development, is a must. Applicants should be outstanding team members with the ability to effectively lead a team and communicate with internal and external stakeholders.
Heres What Youll Do:
Build and maintain strategic relationships with teams and relevant internal and external stakeholders including functional heads to support best practices, create, and improve on process and controlled documents
Oversee the development, optimization and implementation of Clinical Development processes, SOPs, relevant tools, and participate in initiatives for CDO and related functions to enhance our clinical excellence capability that enables Moderna to be successful
Lead, manage, and build out roles and responsibilities for a team of internal associates and functional service providers for process, and SOP strategy and deployment as driven by the portfolio demand
Establish and manage best practice and strategy for business process ownership, development, and work with Clinical Operations Training team to determine associated training within CDO
Develop and implement an aligned cross-functional strategy for SOP development, review, and implementation
Drive SOP and process gap analysis with relevant functions and stakeholders; lead change and implementation on output of gap analysis
Oversee and provide expert input to procedural documents (ex. SOPs, work instructions, etc.) to ensure a strong GCP compliant foundation for the execution of clinical trials and programs
Analyze and provide recommendations for improvement to existing systems or development of new systems to support tracking, reporting, and other activities for training and SOPs
Clearly track and communicate strategy, key deliverables, milestones, and timelines as relates to the business, including setting and monitoring KPIs and metrics related to process development across Clinical Development
Drive a culture of continuous improvement and quality, always looking for ways to reduce cost and timelines, while maintaining the highest level of quality
Heres What Youll Bring to the Table:
BA/BS required; Applicable experience will be considered in lieu of education; Advanced degree preferred
Minimum of 10+ years of experience in a clinical research environment within the pharmaceutical and biotech industry
Experience in building high performing teams and developing team members to be future leaders
Direct experience in SOP development, training, and Clinical Operations
Working knowledge of Document Management Systems
Solid understanding and working knowledge of Contract Research Organizations, third party vendors that support clinical trials, and relationship management
Strong understanding of appropriate regulations and guidelines (ex. FDA and ICH GCP guidelines) and applicability with clinical trials
Outstanding verbal and written communication skills
Ability to manage multiple projects in a fast-paced environment
Ability to collaborate effectively in a dynamic, cross-functional matrix environment
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.
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.