• Serve as overall clinical program owner for oligonucleotide therapeutic programs, driving them from IND submission through clinical proof-of-concept, pivotal studies, and regulatory engagement • Define and lead the clinical development strategy for programs targeting PNS and other relevant indications • Design and oversee early- and late-stage clinical trials (IIT, Phase 1–3) for siRNA therapeutics • Partner with preclinical and translational biology teams to connect mechanistic and biomarker data with clinical endpoints • Oversee cross-functional execution of clinical trials, ensuring alignment across clinical operations, biostatistics, regulatory, and CMC functions • Guide site selection and operational planning across both U.S. and international locations • Lead preparation and review of clinical sections of INDs, Investigator’s Brochures, and regulatory briefing documents • Build and manage productive relationships with CROs, investigators, and KOLs • Inspire and lead multidisciplinary teams, ensuring alignment and collaboration across R&D, clinical, and corporate functions

• Work with the AVP of HEOR and leadership to build a CMAA RWD analytics and insights capability at Inovalon • Own the strategy for integrating Inovalon’s RWD data assets and outside data sources to execute and deliver high-value CMAA projects for Pharma and Medtech clients • Conduct patient journey analytics • Analyze treatment patterns and line of therapy • Lead HCP targeting and segmentation • Assess market share and competitive dynamics • Provide real-world evidence for payer negotiations • Serve as a senior point of contact for key CMAA clients, ensuring high satisfaction and repeat business • Lead proposal development and drive new business capture by identifying client needs and contributing to revenue growth • Spearhead initiatives to automate CMAA use cases using modern workflow, automation, and AI-based tools • Lead, mentor, and grow a high-performing team with expertise in RWD, commercial analytics, and market access

• The AM Director provides single point-of-contact for Customer management; facilitating efficient and effective project execution, ensuring customer needs are communicated internally and addressed appropriately • Will develop addition scopes of work and project change orders with customers by translating expectations and needs into the proposal (by considering budget, timelines and science requirements) • As a key leader on customer projects, work with Project Management to communicate progress against SOW at internal and external meetings • The AM Director ensures any project scope changes are integrated on a portfolio or platform basis as needed • Proactively identifies client issues that may impact project execution and/or internal portfolio • Escalates issues to the Head of AM and management team with proposed solutions when necessary • Proactively enable and support information and exchange between Just Evotec and its customers and implement and manage any governance models called for in customer agreements • Proactively manage and prioritize support for multiple projects in Project Portfolios • Support cross company planning with other Evotec business and technical areas to ensure project execution, capacity utilization and profitable operations • Provide meeting management support including meeting planning, scheduling, facilitation, documentation and outcomes communicated • Assist in the establishment of company best practices and tools

As an Associate Director, Global Development Quality Assurance, you will play a key role supervising, guiding and leading our Good Clinical Practice (GCP) Audit Programs. Responsibilities include managing direct reports, supporting the development and execution of departmental goals and objectives. We also create strategic partnerships and oversee risk-based quality auditing activities. You will also apply your knowledge of the FDA and EU regulations and ICH guidance documents with other regulations that may affect drug development and post-authorization safety monitoring. A typical day include the following: • Manage, hire and develop direct reports at least monthly and conducting Mid-year and End-of year performance assessments. • Responsible for the training, resourcing, and individual staff development of direct reports. • Lead the identification of internal quality/compliance issues and act as a catalyst for process improvements to promote standardization and best practices. • Represent the GDQA audit function by providing audit and compliance input in cross functional meetings. • Represent GDQA on high-priority and highly visible teams, compliance projects and initiatives both within and across functional areas or other departments as applicable. • Assist managing staff resourcing (internal & external) to accomplish the annual audit schedules. • Assist assessing and prioritization of both internal and external audit needs. • Assist with the drafting and issuance of periodic metrics reports to management, cross functional groups and leadership teams as requested. • Interpret and may assist in developing policies, standards, and regulations, and evaluates potentially critical problems. • Responsible for “end to end” audit process which includes: • Scheduling, preparing, conducting, reporting, and follow-up on audits in support of routine and directed GxP audits as needed and in accordance with Regeneron standard operating procedures and quality policies. • Audits include internal audits and external audits conducted globally • Provide education and/or training to GDQA staff and other relevant Global Development departments. • May participate in regulatory inspections by acting as part of the control and/or inspection room team • This role may require 20 – 30% travel (both domestic and international) This may be for you if you: • Demonstrated skills in taking initiative and working independently • Self-motivated with the ability to work effectively in a dynamic environment with ambiguity • Ability to effectively manage multiple complex priorities and direct reports • Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations To be considered a Bachelor’s degree (Master’s degree preferred) with 11+ years of relevant industry experience including 9+ years of direct people management and/or GCP audit experience preferred. Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs. Good problem solving, written and verbal communication skills and uses professional concepts to evaluate problems and develop solutions for critical issues. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $157,200.00 - $256,600.00