SciPro is representing a leading global pharmaceutical company dedicated to creating and supplying innovative pharmaceutical therapies. This esteemed organization's mission is to enhance standards of care and address diverse, unmet medical needs worldwide by leveraging world-class science and technology. With over a century of scientific expertise and a presence in more than 20 countries, the company and its 15,000 employees globally draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to make a meaningful difference in people's lives.
Guided by their 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” the company is primarily focused on delivering novel therapies in oncology, as well as conducting research in areas related to rare diseases and immune disorders. SciPro is currently seeking oncology physician talent to contribute to this impactful mission and join their dedicated team.
Oversees a number of trials of a multinational program in a specific indication, i.e., multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL).
Medical Monitoring Planning: (MD only) For large Phase 3 studies: Reviews, edits, approves, and updates the medical monitoring plan. Develops SAE flow plan for AESI in conjunction with CSPV. Defines the medical monitoring oversight component of the study QOP. Sets up DSMB and/or adjudication committee; reviews and edits DSMB/Adjudication charters. Develops medical content for protocol profile, protocol, and amendments for small, uncomplicated clinical studies. Coordinates sponsor medical monitors across regions. Directs CRO medical monitor activities for a large study and/or across a program.
Medical Surveillance: (MD only) For studies within a project: Collaborates with CSPV to ensure monitoring/reporting of AEs/SAEs. Reviews safety reports/data during study conduct. Provides and documents oversight of medical monitoring activities. Reviews data before DBL from a medical perspective, assists BDO in the creation of TFG. Reviews and oversees the creation of patient narratives. Provides medical direction to MW for the CSR. Working with Clinical Safety Pharmacovigilance (CSPV), defines product-level surveillance plan and interpretations, e.g., language for IB. Documents ongoing MM review of data for safety (with CSPV) and quality at the project level.
Study Strategy: For Phase 2 and Phase 3 registrational studies: Provides strategic direction to BDO for EDC, edit checks, data quality listings, SAP, DM plan. Reviews patient population and protocol compliance for consistency with study strategy. Develops biomarker strategy in collaboration with TMCP. Collaborates with external KOLs to refine study plans. Prepares and participates in regulatory agency meetings, if applicable. Defines study strategy across clinical trials within an indication or project. Attends EOP2 meetings and represents clinical/TMCP.
Study Planning and Execution: Clinical Study Lead (CSL) for large Phase 3 registrational studies. Develops prospective contingency plans for the management of key risks in a large study or project. Clearly defines study priorities and high-level execution plan, communicates to members of the study team within sponsor, CRO, and vendors. Ensures clear and effective lines of communication and decision-making processes cross-functionally and cross-regionally. Facilitates team coordination.
Study Outputs: For Phase 3 studies: Drafts responses to IRBs and HAs. Collaborates with TMCP to ensure appropriate biomarker, PK/PD measurements. Reviews emerging clinical data regularly. Leads dose-escalation meetings. Performs quality assessment with delivery lead, e.g., review TLG before DBL, and quality check of data. Works with BDO to ensure SAP updates. Interacts with Key Opinion Leaders (KOLs) to validate the interpretation of study results. Presents results to regulatory agencies during pre-submission meetings. Interprets study results in the context of other studies in the project and other drugs used for the indication.
External Collaboration: Develops and leads Ad-Board with top-tier KOLs for project-level strategic advice. Develops and leads steering committee for Phase 3 registrational study. Consults with KOLs for advice on complex development or safety issues.
Scientific, Program-Related: Integrated Study Team (IST) representative or IST leader on the study team. Responsible before senior management for the creation and execution of development strategies for program/s under IST. Obtains cross-functional alignment. Leads the development and execution of the Product Development Plan and clinical development strategy. Leads Integrated Project Team (IPT) working closely with Global Project Management to ensure cross-functional coordination and focus on agreed strategy. Coordinates clinical activities across the project. Represents IPT to Senior Management.
People Management: Leads large study or project teams involving multiple functions and many members with or without a direct reporting relationship.
Additional Non-Study Related Activities: Provides input on KOL selection for Therapeutic Area. Reviews content to be shared with KOLs. Frequent involvement in Business Development activities for late-stage compounds. Involvement with in-licensing and acquisitions in due diligence activities. Major contributor to portfolio decisions.
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications: (from an accredited college or university)
Postgraduate training in TA or related specialty required
4 or more years of relevant clinical experience required