Clinical Research

• Provide strategic HCC leadership, oversight and execution of the G lobal Health Care Compliance program for R& D, Clinical Research, Medical Affairs, and related activities.
• Act as a compliance partner and trusted advisor to G lobal R&D, Clinical Research and Medical Affairs teams, providing timely , practical guidance on clinical trials, investigator and site interactions, advisory boards, and scientific exchange.
• Assist in identifying , assessing, and mitigating compliance risks associated with clinical research activities and medical engagement models.
• Support compliance risk assessments, issue management, and monitoring activities related to R&D, Clinical Research and Medical Affairs.
• Collaborate with Legal, Privacy, Quality, Finance, and other assurance functions to deliver coordinated compliance support and risk mitigation.
• Contribute to the development, implementation, and maintenance of policies, procedures, and training materials related to R&D, Clinical Research and Medical Affairs compliance.
• Support responses to internal inquiries, audits, monitoring activities, and regulatory requests related to clinical and medical compliance topics.

Clinical Research Manager, Medical Affairs

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans)
• Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place
• Contribute to the development of the project risk mitigation plan. Manage clinical risks through the project lifecycle
• Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues
• Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver
• Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work
• Work as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials
• Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management
• Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements
• Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings
• Conduct regular team meetings and communicate appropriately to achieve objectives
• Support professional development by providing feedback to clinical team line managers on performance relative to project tasks to support professional development
• Adopt corporate initiatives and changes and serve as a change advocate when necessary
• May contribute to the development of the clinical delivery strategy for business proposals. Participate in bid defense preparations and meetings
• Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership
• May mentor and coach new peers as they assimilate into this role
• May attend site visits as applicable in support of project delivery

Senior Clinical Trial Manager

• Lead in the development, evaluation, planning and execution of clinical studies
• Ensures scientific integrity and interpretation of study data of a clinical development program
• Collaborates closely with Medical Director (MD) to provide scientific expertise
• Develops/maintains proficient understanding of therapeutic disease area(s) and drug candidate
• Applies basic scientific expertise to support initiation and execution of clinical research and development studies for early and/or late-stage assets
• Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings
• Assists with development of the Expanded Synopsis and may author clinically relevant sections

Manager, Clinical Scientist, Hematology

• Managing and directing clinical research activities involving new or marketed drugs in the Oncology Clinical Research group and in the field of Thoracic Oncology.
• Managing the entire cycle of clinical development, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings.
• Provide internal scientific leadership for cross-functional areas supporting clinical trials and interact externally with key opinion leaders.
• Evaluating pre-clinical and translational work for generating early clinical development plans and Investigational New Drug applications.
• Developing clinical development strategies for investigational or marketed agents that incorporate the latest scientific developments, regulatory requirements, competitive landscape, and commercial considerations.
• Planning clinical trials based on these strategies.
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed agents.
• Analyzing and summarizing clinical findings to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications.
• Participation in internal and joint research project teams relevant to the development of new compounds and the further study of marketed compounds.

Distinguished Scientist, Clinical Research, Thoracic Malignancies

• lead the clinical trial strategy for multiple myeloma assets
• create synergies across Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance
• author protocols, extended synopses, clinical sections of the Investigator Brochure, IND/IMPD fillings, annual reports
• provide expert medical guidance to other functions
• present and discuss development strategy and clinical study results with key stakeholders

Senior Clinical Research Director – Oncology

• Responsible for the development, execution and reporting of clinical trials in support of the registration of a product
• Development of abbreviated protocol and clinical protocol
• Participation in the review process for protocols, study reports, labeling, and interactions with regulatory agencies and ethics committees
• Drive breakthroughs that could turn the impossible into possible for millions
• Ensure that all development activities are targeted towards timely achievement
• Interact with opinion leaders and external consultants
• Serve as medical monitor for the studies assigned
• Ensure clinical data meets all necessary regulatory standards

Clinical Research Director – Immunology and Inflammation

• Lead efforts in resolving day to day work related issues and problems, securing quality, improving efficiency and productivity of statistical and programming operations
• Provide statistical expertise for design, analysis and reporting of clinical trials and research projects
• Develop and/or review ADaM dataset specifications
• Perform statistical analysis as per SAP, and address peer/QC review comments and findings
• Provide statistical input to Case Report Forms (CRF) design and database/variable structure

Senior Biostatistician

• Planning clinical trials (design, operational plans) based on the clinical development strategies for investigational or marketed infectious disease drugs
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed infectious disease drugs
• Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications
• Participation in internal and joint internal/external research project teams relevant to the development of investigational drugs, and the further study of marketed drugs
• Developing clinical development strategies for investigational or marketed infectious disease drugs

Senior Director, Clinical Research

• Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing.
• Advance the CDP through internal management review.
• Leads a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol.
• Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations.
• Review documents supporting clinical development such as Investigator’s brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval.
• Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation).
• Contribute to data review, interpretation and publication of clinical study results.
• Represent Clinical Development at Health Authorities and incorporating advice into development strategy.
• Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program.
• Align company position on clinical strategy with partner in alliance projects.
• Translate biology into clinic in close collaboration with research and translational medicine.
• Evaluate clinical aspects of business development opportunities as needed.
• Apply high ethical standards and work with integrity.

Clinical Research Director

• shape and execute clinical development strategy for assigned rare disease programs
• drive programs from early development through registration with a patient-centric focus
• serve as a recognized scientific authority within the Rare Disease TA
• lead design and authorship of study synopses, CDPs, and clinical sections of IDPs
• oversee end-to-end trial execution through cross-functional units, ensuring GCP and regulatory compliance
• define and manage timelines, budgets, and risk mitigation strategies
• serve as strategic clinical lead and medical spokesperson within the Global Project Team, Protocol Review Committee and Executive Leadership
• contribute to biomarker identification and provide due diligence support for business development opportunities
• drive timely publication of clinical data in peer-reviewed journals and at scientific congresses
• align cross-functional stakeholders around a unified development vision; present CDPs to governance and senior leadership
• mentor Clinical Research Directors and Clinical Scientists and contribute to talent development within the Rare Disease TA

Senior Clinical Research Director, Rare Disease

• The Executive Director will manage and oversee the entire cycle of late-stage clinical development from Phase 2 to Phase 5, including development of program strategy and design, protocol authoring, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings.
• They will lead cross-functional product development teams that oversee program strategy and execution, will provide internal scientific leadership for cross-functional areas supporting clinical trials, and will interact externally with key scientific leaders.
• Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug (IND) applications.
• Developing clinical development strategies for investigational or marketed medicines that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations.
• Executing the clinical strategy, planning clinical trials (design, operational plans, settings), and leading the clinical subteam.
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed medicines.
• Leading cross-functional product development teams that oversee overall strategy and execution for investigational or marketed medicines.
• Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications.
• Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds.

Executive Director, Product Development Team Leader, Clinical Research, Hematology – Lymphoma

• Planning and directing clinical research activities involving new or marketed Neuroscience Medicines.
• Managing the entire cycle of clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings.
• Providing internal scientific leadership for cross-functional areas supporting clinical trials.
• Interacting externally with key opinion leaders.
• Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications.
• Developing clinical development strategies for investigational or marketed Neuroscience drugs.
• Planning clinical trials based on these clinical development strategies.
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Neuroscience drugs.
• Analyzing and summarizing clinical findings to support decisions regarding safety and efficacy, as well as new drug applications and clinical study reports.

Senior Principal Scientist, Clinical Research, Neuroscience

• Planning and executing clinical-trial biomarkers across the pipeline
• Ensuring compliant, efficient biospecimen collection, assay execution, and data delivery
• Driving operational excellence, data quality, and compliance across the biomarker assay project lifecycle
• Partnering closely with scientific and operational colleagues to support a cohesive and agile team that delivers high-quality biomarker data for clinical trials and translational research
• Collaborating closely with biomarker scientists and study teams to plan clinical-trial biomarker set-up and logistics
• Serving as the operational partner to Biomarker Leads, helping implement strategies that advance biomarker programs
• Co-authoring biomarker-related sections of clinical study protocols
• Collaborating with Translational Molecular Biomarker Scientists to define and manage specimen collection, handling, shipping, storage, and processing requirements
• Developing biomarker vendor statements of work and data-transfer specifications in partnership with clinical teams
• Working with clinical teams to coordinate sample and assay logistics, issue resolution and risk mitigation
• Partnering with Data Management to transfer biomarker data from external vendors into the clinical data repository
• Designing sample collection kits, laboratory manuals, and specimen logistics for shipments to third-party vendors
• Building and maintaining effective partnerships with external biomarker vendors and internal teams
• Proactively identifying and resolving conflicting stakeholders needs to maintain alignment and momentum
• Implementing and continuously improving streamlined workflows that maximize efficiency and data quality

Senior Scientist, Clinical Research – Biomarker Operations

• primary responsibility for planning and directing clinical research activities
• managing the entire cycle of clinical development including study design, placement, monitoring, analysis, regulatory reporting, and publication
• evaluating pre-clinical and translational work to generate early clinical development plan
• developing clinical development strategies for investigational or marketed Oncology drugs
• planning clinical trials and monitoring the conduct of ongoing or new clinical trials
• analyzing and summarizing clinical findings to support decisions regarding safety and efficacy
• supervising activities of Clinical Scientists
• collaborating with a cross-functional group of experts

Senior Principal Scientist, Clinical Research, Lymphoma

• Accountable for the end-to-end performance and project management for assigned protocols in compliance with ICH/GCP and country regulations
• Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT)
• Responsible for project management of the assigned studies, driving and tracking execution and performance to meet commitments
• Reviews Monitoring Visits Reports and escalates performance issues
• Leads local study teams and trains in the protocol
• Creates and executes a local risk management plan for assigned studies

Clinical Research Manager – Ophthalmology

• Act as a mentor for other CRDs and Clinical Scientists on a same project/TA
• Collaborate with functions to ensure uniform, aligned operational approach
• Provide medical expertise to the clinical studies
• Support other clinical development activities
• Contribute to the clinical part of submission dossier for their projects
• Interact with other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional reps

Senior Clinical Research Director, I&I

• Planning and directing clinical research activities involving new medicines in the Oncology Asset therapeutic area
• Managing the entire cycle of clinical development for their assigned studies including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication
• Evaluating pre-clinical and translational work for generating early clinical development plans and Investigational New Drug applications
• Developing clinical development strategies for investigational drugs
• Planning clinical trials based on the clinical development strategy
• Medical oversight and overall conduct of ongoing or new clinical trials for investigational drugs
• Analyzing and summarizing clinical findings from studies to support decisions regarding safety and efficacy
• Participating in internal and joint internal/external research project teams relevant to the development of new compounds

Senior Principal Scientist, Clinical Research, ADC

• Planning and directing clinical research activities involving new or marketed medicines in the Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area
• Managing the entire cycle of late-stage clinical development and studies, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication
• Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications
• Developing clinical development strategies for investigational or marketed Atherosclerosis drugs
• Planning clinical trials (design, operational plans, settings) based on these clinical development strategies
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Atherosclerosis drugs
• Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications
• Participating in internal and joint internal/external research project teams relevant to the development of new compounds and the further study of marketed compounds
• Supporting business development assessments of external opportunities
• Supervising the execution of clinical studies
• Working closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects
• Assisting the Executive Director and/or Associate Vice President in ensuring that appropriate Corporate personnel are informed of the progress of studies of the company and competitors' drugs, and of internal and external expert opinions on scientific questions

Senior Director, Clinical Research – Atherosclerosis

• The Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines.
• The Senior Director will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.
• Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications
• Development of clinical development strategies for investigational or marketed Oncology drugs
• Planning clinical trials (design, operational plans, settings) based on these clinical development strategies
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs
• Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications
• Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds.
• Lead a cross-functional team including Clinical Scientists in endeavors ranging from drafting clinical study protocols to overseeing protocol adherence to assessing patient-level data, ensuring data completeness and integrity, and ultimately interpreting and contextualizing aggregate data to assess safety and efficacy
• Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects
• Assist the Executive Director in ensuring that appropriate corporate personnel are informed of the progress of studies of our Company's and competitors' drugs and engage with internal and external experts on scientific questions relevant to their areas of responsibility.
• Maintain a strong scientific fund of knowledge by maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies.
• Identification of scientifically and operationally strong investigators who can assist in the development of our Company's investigational and marketed drugs
• Establishing communications with prominent clinical investigators in their particular field of interest, particularly those who will be willing and able to assist in the evaluation of our Company's drugs
• Attend appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility.
• Author detailed development documents, presentations, budgets, and position papers for internal and external audiences
• Facilitate collaborations with external researchers around the world
• Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.

Senior Principal Scientist, Clinical Research, GI Oncology

• Lead, co-lead, or support one or more clinical trial(s) in a therapeutic area for one or more compounds.
• Works closely with Medical Director and other Sr. level Clinical Research Scientist (as warranted)
• Contributes to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP)
• In collaboration with the Medical Director, contributes to the development of clinical and regulatory documents, annual safety updates, and registration dossiers (ie, protocol, ICF, IB, annual safety updates, study reports, regulatory submissions [Briefing documents, IND, Clinical dossiers] to support registration and commercialization of the compound(s)
• Participates in the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables (e.g. database lock activities).
• Lead the development of the medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis
• Contributes medical input for country/site selection, feasibility assessment and engage in KOL interaction
• Prepare charters and coordinate internal/external committee meetings including presentation preparation (ie, Dose Escalation Committee, DMC, Steering Committee, and Safety Committees)
• Participate in the development and review of study plans and serve as a liaison to project teams and CROs
• Provide input for the development of publications in coordination with Scientific Communications
• Contribute to training at Investigator meetings, CRO/CRA training, SIVs as warranted

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