Lead Clinical Scientist or Global Clinical Leader for one or more early Breakthrough Science or Antibody-Drug Conjugate (ADC) clinical assets. Responsible for establishment and execution of clinical drug development strategy. Consults with scientists in Research Labs to deliver non-clinical package necessary to supporttranslation into clinical program. Design and oversight of Phase I first-in-man clinical trials, in addition to more advanced PhIb combination and PhII multinational clinical trials. Provides Medical input and monitoring for active trials. Works closely with Translational Science and Translational Research (Biomarker and CDx) functions to incorporate appropriate assays and plan into the clinical program. Drafts clinical development plans and protocol profiles, and works with team on clinical protocols and investigator's brochure; Participates in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs; Reviews regulatory documents from cross functional, holistic perspective; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters and represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Supports marketing in developing a commercial strategy include biomarker strategy; Supports Business Development and Licensing for evaluation of new assets. Represents Clinical Development as Global Clinical Lead or as Team Leader
- Program and Study Strategy: Works with cross-functional team to develop comprehensive clinical strategy for program, and studies needed to address this. Lead development of protocol profile to answer key clinical/scientific questions on compound. Work closely with Research, Quantitative Clinical Pharmacology, Translational Science , Translational Research, Statistics, Clinical Operations, Regulatory, and other cross-functional team members colleagues on protocols. Develops biomarker strategy in collaboration with Translational Science, Collaborates with external KOLs to refine study plans; Defines study strategy across clinical trials within an indication or project
- Study Planning and Execution: Provides the strategic direction to Data Management for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for consistency with study strategy, Develop prospective contingency plans for management of key risks in a large study or project; Clearly define study priorities and high level execution plan, communicate to members of study team within sponsor, CRO and vendors; Ensure clear and effective lines of communication and decision-making process cross-functionally and cross-regionally; Facilitate team coordination
- Study outputs: Drafts responses to IRBs and HA, Collaborates with QCP and Translational Science 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 Data Management to ensure SAP updates; Interpret study results in context of other studies in the project and other drugs used for the indication
- Medical monitoring planning: For large Phase 3 studies: Reviews, edits, approves and updates medical monitoring plan, Develops SAE flow plan for AESI in conjunction w/ CSPV, Defines medical monitoring oversight component, Sets up DSMB and/or adjudication committee (as needed); Develops medical content for protocol profile, protocol and amendments; Direct 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 medical perspective, assist BDO in creation of TFG, Reviews, oversees 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 project level
- External collaboration: Engages with top tier KOLs for project level strategic advice and advisory boards; Develops and leads steering committee for key trials; Consults with KOLS for advice on complex development or safety issues
- Scientific, Program related: Clinical Study Team (CST) leader on study team; Responsible before senior management for the creation and execution of development strategies for program/s under CST or GPT; Obtains cross-functional alignment ; Leads development and execution of Product Development Plan and clinical development strategy; Key Core member of Global Project Team (GPT) working closely with Global Project Management to ensure cross-functional coordination and focus to agreed strategy; Coordinates clinical activities across the project. Works with team members to drive peer-reviewed publications and external presentations (conferences) related to program.
- 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 early stage or preclinical assets; Involvement with in-licensing and acquisitions on due diligence activities; Major contributor to portfolio decisions
- MD highly preferred, PharmD, PhD or equivalent with exceptional qualifications acceptable; Postgraduate training in Oncology or Hematology, or meaningful past in field.
- Strategic Thinking, Clinical Trials Knowledge, Influencing Skills, Scientific Knowledge, Oncology Expertise, Drug Development, Critical Thinking, Team Leadership.