• Lead UBC project teams to deliver project milestones • Serve as the primary contact with the sponsor for all study related items • Oversee all aspects of project conduct, from study start-up through close-out • Execute operational aspects of assigned project activities • Assist in the development and design of protocols, CRFs, regulatory documents, project master file, and other project related deliverables • Ensure operational plans are developed consistent with project needs • Monitor project progress as compared to established plans and ensure compliance • Facilitate and plan investigator meetings • Recruit qualified investigators and assist in budget negotiations • Supervise APM/PMs and other team members to ensure project deliverables • Provide reports to the Sponsor on project progress • Maintain project documentation to be "audit ready"

Role Description The Clinical Trial Educator (CTE) reports to and works with the Exec/Sr./Director of Clinical Operations to provide a high-touch service to clinical study investigators and site research teams. This is accomplished through ongoing engagement for Eidos clinical trials with a purpose of proactively increasing study and data quality and proactively identifying and mitigating operational risks. The CTE is a critical role in keeping the study “top of mind” with our sites, guiding sites through complex study procedures, and is one of the key Sponsor points-of-contact for the Principal Investigators and all clinical site research staff team members. The CTE will continually look for opportunities to optimize the execution of the study(ies) in such a way as to ensure robust protocol adherence, GCP compliance and high-quality data collection in a timely manner. Responsibilities - Maintains clinical knowledge of the therapeutic area landscape including current treatment strategies, current and pending competitors, and new therapeutic developments. - Establishes and maintains collaborative relationships with key therapeutic area experts, investigators, and institutions, serving as a key Eidos contact for investigative sites. - Collaborates with clinical development and operational teams, as well external service providers as appropriate to coordinate and optimize educational and research support for sites/investigators participating in BBIO's clinical trials, creating and contributing to study documents as needed. - Provides ongoing evaluation of enrollment status by site to ensure they are meeting expected goals, as well as patient compliance and study completion. - Provides white glove experience and oversight of key study procedures during identified needs, such as screening, working with sites to ensure understanding and guide through the process as needed. - Identifies and communicates key clinical and investigational study issues and insights from investigative sites to appropriate departments to help shape program level strategies, and assists study centers and CROs with “trouble-shooting” throughout the study, including site start-up activities, support during study maintenance, and supporting study endpoints through specifically training procedures. - As requested, participates in medical education for healthcare professionals through presentations and investigator interactions such as investigator meetings and other appropriate venues to enhance product and disease state knowledge. - May assist in CRA monitoring oversight as needed. Qualifications - BA/BS or MA/MS in biological or medical field required or relevant experience; advanced degree or clinical background preferred. - Minimum of 10 years of relevant clinical experience in the pharmaceutical, biotech and/or CRO industries, with at least 5 years of experience in a similar role. - Strong interpersonal skills and excellent relationship-building skills. - In-depth knowledge of FDA regulations, GCP, GCDMP and ICH guidelines required. - Clear scientific curiosity and interest in drug development. - Strong verbal and written communication skills. - Passion for helping patients. - Identifies and applies advanced practices, technical principles, theories and/or concepts, and contributes to the development of new principles and concepts; has a comprehensive understanding of current approaches in industry and ability to incorporate them into Eidos’ programs. Requirements - Travel- 20% Benefits - Market-leading compensation. - 401(k) with employer match. - Employee Stock Purchase Program (ESPP). - Pre-tax commuter benefits (transit and parking). - Referral bonus for hired candidates. - Subsidized lunch and parking on in-office days. - 100% employer-paid medical, dental, and vision premiums for you and your dependents. - Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA). - Fertility & family-forming benefits. - Expanded mental health support (therapy and coaching resources). - Hybrid work model with flexibility. - Flexible, “take-what-you-need” paid time off and company-paid holidays. - Comprehensive paid medical and parental leave to care for yourself and your family. - People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility. - We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching. - We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities.

Role Description Otsuka is seeking a Senior Manager, Global Clinical Development (GCD) - Metabolic Dietitian based remotely or in our Princeton, NJ or Rockville, MD offices, who will be responsible for providing dietary and metabolic expertise to support the design, execution, and oversight of clinical research programs under Good Clinical Practice (GCP). The incumbent will support the clinical development of therapies for Rare Diseases and Inherited Metabolic Disorders (e.g., PKU, UCD, MSUD) across multiple stages of development. - Consults with investigators, site dietitians, patients, and cross‑functional partners and applies insights to optimize study design, dietary endpoints, and protocol implementation. - Serves as a metabolic nutrition subject‑matter expert, supporting clinical development, medical affairs, regulatory, and other project team members. - Provides input into protocol design and study strategy, particularly for trials involving dietary interventions, normalization, and metabolic endpoints. - Oversees dietary data collection and quality, ensuring consistency, accuracy, and adherence to protocol‑specified dietary guidelines. - Supports site selection, training, and ongoing engagement of site dietitians and investigators. - Provides guidance on dietary variability and its impact on clinical endpoints, ensuring appropriate interpretation of study results. - Collaborates cross‑functionally with Clinical Operations, Biostatistics, Regulatory, and Medical Affairs to support study execution and data interpretation. - Contributes to analysis and communication of clinical trial results, integrating dietary context into scientific outputs. - Supports post‑approval readiness and real‑world implementation, ensuring alignment between clinical data and dietary practice. - Engages with external stakeholders, including metabolic dietitian networks, professional societies (e.g., GMDI), and key opinion leaders. - Supports vendor and CRO interactions related to dietary components of clinical trials. Qualifications - Registered Dietitian (RD/RDN) with expertise in metabolic or inherited metabolic disorders. - ≥ 5 years of experience in clinical practice, clinical research, or pharmaceutical/biotech industry. - Demonstrated experience in dietary management of PKU and/or other IEMs. - Experience supporting or participating in clinical research or clinical trials. - Strong understanding of dietary assessment methods and metabolic clinical endpoints. - Ability to communicate effectively in meetings and via written and oral presentations. - Experience working in cross‑functional, matrixed environments. Requirements - Experience in pharmaceutical or biotech clinical development (preferred). - Familiarity with GCP and regulatory requirements (preferred). - Experience with protocol development, site training, and/or real‑world evidence generation (preferred). - Established network within the metabolic dietitian community (preferred). - Experience engaging with professional organizations (e.g., GMDI) (preferred). Benefits - Comprehensive medical, dental, vision, prescription drug coverage. - Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance. - Tuition reimbursement and student loan assistance. - A generous 401(k) match. - Flexible time off, paid holidays, and paid leave programs. - Other company provided benefits.

Role Description We are seeking a Global Clinical Operations Leader/Clinical Trial Manager to join our team in a remote position. As a Global Clinical Operations Leader/ Clinical Trial Manager, you will lead the clinical operations strategy and execution of global clinical trials. This role has direct accountability for delivering studies on time within budget and to the highest quality standards while ensuring patient safety and regulatory compliance. You will serve as the primary clinical liaison to project leadership and sponsor teams coordinating cross functional contributors across regions and time zones. This is a highly visible leadership role suited for individuals who thrive in complex global environments and are comfortable making decisions in ambiguous situations. Success requires strong ownership, the ability to lead without close supervision and a history of delivering clinical trials within a CRO environment. Key Responsibilities - Lead global clinical operations strategy and execution for assigned clinical trials. - Drive study startup including site selection, monitoring strategy, and operational planning. - Coordinate cross functional teams across geographies ensuring alignment on timelines, quality and deliverables. - Monitor study progress including recruitment, retention, data quality and timelines and take corrective action when needed. - Identify risks early and implement mitigation and contingency plans. - Provide leadership direction and performance feedback to project team members. - Function as primary point of contact for sponsors on clinical operations topics. - Ensure compliance with ICH GCP regulatory requirements and internal processes. - Oversee maintenance and quality of study documentation and central files. - Support audits, inspections and study closeout activities including database lock and archiving. - Provide strategic oversight of the integrated data delivery (IDD) framework and champion a proactive data-quality culture. Qualifications - Strong leadership, decision making and problem-solving skills. - Demonstrated ability to lead global teams across cultures and time zones. - Ability to prioritize competing demands and remain accountable for outcomes. - A proactive mindset with strong ownership and sense of urgency. - Excellent communication and stakeholder management skills. - Comfort working in a fast-paced performance driven environment. Requirements - Degree in life sciences, nursing, or equivalent clinical research experience. - Minimum of 5 years of experience leading clinical operations within a CRO environment. - Proven experience in roles such as Clinical Trial Manager, Clinical Project Manager or Clinical Operations Leader. - Experience leading complex global or multi-region studies. - Strong knowledge of ICH GCP regulatory requirements and clinical trial processes. - Experience coordinating cross functional teams and managing study timelines, budgets and quality. - Proficiency with clinical systems and standard tools such as CTMS, EDC, and eTMF. Preferred Qualifications - Prior monitoring experience or strong site engagement background. - Experience contributing to process improvements or operational excellence initiatives. - Familiarity with multiple therapeutic areas or late phase studies with priority given to those with Metabolic, Obesity, MASH, Ophthalmology and Dermatology / Immunology. Benefits The potential base pay range for this role is competitive and aligned to experience level, location and demonstrated expertise. Additional incentives may be available based on performance and role scope. This role is designed for experienced clinical leaders who are ready to take full ownership of global trial delivery. If you are looking for a position with clear accountability, high expectations and meaningful impact on patient outcomes this is the right opportunity. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.