Parexel

Title: Medical Director, Oncology / GI Subspecialty Location: United States-North Carolina-Remote Job Description: At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. During the last five years, Parexel has participated in more than 1,000 Oncology and Hematology clinical projects. The range of services includes compound clinical development planning, collaboration with feasibility, protocol writing or optimization, medical monitoring and pharmacovigilance. Parexel has global presence in every phase of clinical research and expertise in virtually every indication and mechanism of action, including novel Immuno-oncology agents, cellular based therapy, and cancer stem cell targeted treatment. Join our growing team of Oncologists and make a difference in the lives of patients searching for more effective and better tolerated cancer therapies. Parexel’s continued success has positioned us for significant North American growth in the coming year. As we prepare for this expansion, we’re seeking to connect with Board-Certified Oncologists who are passionate about advancing clinical research and interested in learning more about the Medical Director role. *Candidates with a subspecialty in Gastroenterology are particularly desirable for this role. As a Medical Director at Parexel, you will provide medical monitoring for assigned projects, function as medical representative on the project team, provide medical consultation as required or requested to client/sponsor or to other Parexel service groups, and assume the role of Senior Technical Lead in selected circumstances. In addition, you will also: - Review all individual adverse experience reports for accuracy and clinical importance, and characterize their relationship to the study drug, severity and seriousness. - Provide reports to FDA or other regulatory agencies and the sponsor on a periodic and regular basis, summarizing adverse experiences as required by FDA or the sponsor, depending on the contract. - Review data listings of safety data, including adverse experiences, laboratory data, and vital signs data, to establish the presence or absence of abnormal trends, and if noted, follow up as appropriate with the project team, sponsor, investigator, and FDA. - Review documents written by various Parexel divisions for safety issues. - Review coding of adverse events and concomitant medications for accuracy and consistency. - Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents for clients/sponsors or in conjunction with clients/sponsors and in conjunction with other Parexel divisions. - Attend and present material, as requested, at meetings within Parexel as well as extra-company external meetings and conferences Required Qualifications - Medical Degree from an accredited institution - Board Certification / Fellowship in Oncology or equivalent training - 2+ years of experience in adult oncology - Prior experience as a Medical Monitor, Industry Physician, Primary Investigator, or Sub-Investigator highly preferred Successful applicants will also have: - Strong interpersonal skills and the ability to collaborate effectively with sponsor and client partners - Excellent time‑management capabilities - Clear, professional verbal and written medical communication skills - A high standard of written and spoken English - Comfort working in a matrixed, team‑oriented environment - Willingness to travel up to 10% domestically and/or internationally as needed 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.

• Effectively communicate with internal and external customers as well as third-party vendors; prioritize effectively and respond to urgent requests within the team or from the sponsor • Oversee and/or manage study start-up activities as applicable • Provide inputs to project tools and study plans • Develop site selection and monitoring plans • Ensure all team members have access to study systems, tools, and documents • Identify, organize and deliver (where appropriate) study specific training in collaboration with Project Leader and Project Specialists • Provide leadership and direction to project team members • Monitor study timelines, patient recruitment, retention, and data cleaning to ensure successful outcome of the project • Participate in sponsor, investigator and team meetings • Collaborate with project team on database lock activities and ensure compliance with applicable guidelines and procedures

• Act as PAREXEL’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol • Build relationships with investigators and site staff • Monitor and maintain compliance with ICH-GCP and applicable international and local regulations • Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis • Conduct on-site visits for Qualification and Initiation visits • Generate visit/contact report • Evaluate overall compliance and performance of sites and site staff • Ensure that assigned sites are audit and inspection ready • Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships

• Relationship Management: Work alongside project team to help develop a partnership with all Parexel departments. • Project Management: Provide support with quality review, audits, and ongoing maintenance of SOPs. • Financial Management Budget Pricing/Development: Participate in budget briefing meetings. • Contracting: Working alongside MedCom account leads/Customer Strategy Directors to support the set-up of new Clients. • Business Development Support: Work with the Account Manager/Manager/Director/VP to support business opportunities for MedCom.

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable laws, Good Clinical Practices • Manage operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through database lock • Interface with the study team, facilitate information flow between team members and vendors • Monitor site level AEs and SAEs, collaborate with Drug Safety Unit and follow-up with investigators

• Support quality control of functional or cross-functional systems in line with Parexel's strategies • Manage selection/creation of relevant testing scenarios • Conduct Software Quality reviews of functional requirements • Write and execute functional & non-functional test plans/cases within an agile environment • Test software to ensure compliance with SOPs, regulatory requirements • Create test cases, traceability records, and regression test packs • Analyze bugs and errors, document the results, and track defects • Collaborate with stakeholders to report on progress and system quality

• Leads the preparation of complex scheduled and unscheduled aggregate safety reports across multiple product types and regulatory regions. • Develops strategic approaches for challenging safety submissions. • Reviews and approves high-complexity safety documents. • Manages meeting logistics including scheduling, agenda drafting, and minute preparation. • Designs and implements advanced signal detection plans tailored to specific product profiles. • Leads signal detection for priority products by conducting expert-level analyses. • Authors and reviews high-priority signal assessment reports and health authority response documents. • Prepares and handles reviews of health authority response documents. • Collaborates with cross-functional teams to ensure RMPs are scientifically robust and compliant. • Demonstrates deep expertise in safety profiles across a wide range of therapeutic areas.

• Leads or contributes to the preparation and compilation of aggregate safety reports. • Reviews and finalizes safety documents for accuracy and compliance. • Coordinates submissions to regulatory authorities. • Conducts literature searches and systematic reviews. • Identifies complex data discrepancies. • Supports development of Risk Management Plans. • Actively contributes to safety strategy discussions. • Serves as primary client liaison for projects. • Monitors KPIs and SLAs for assigned deliverables. • Mentors junior team members by providing training.

• Independently lead the preparation/update of complex aggregate safety reports across multiple product types • Manage the distribution of final reports to stakeholders, including partners and health authorities • Leads advanced safety signal detection and management for key products • Collaborates with cross-functional teams to analyze complex safety data • Provides strategic scientific expertise across therapeutic areas

• Adapt global templates of agreements to local use in accordance with local requirements and SOPs. • Develop and negotiate clinical site budgets based on Fair Market Value. • Negotiate agreement language and budget with clinical study sites. • Act as point of contact and interface with Legal if necessary to ensure integrity of contracts. • For each agreement maintain the status of agreement, budgets, issues, payments, any amendments for the duration of the study, and communications with internal and external sources. • Ensure final contract documents are consistent with agreements reached at negotiations. • Ensure all agreements are executed in a timely manner contributing to efficient site start-up timelines. • Support internal and external audits activities. • Ensure compliance with client’s Code of Conduct and company policies and procedures relating to people, finance, technology and security. • Ensure that all contracts are included in the TMF.