Associate Clinical Research Medical Director - Oncology RLT

September 16

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Novartis

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Cardiovascular • Immunology • Neuroscience • Solid Tumors • Hematology

10,000+

Description

• Accountable for all country clinical/medical aspects associated with Development and prioritized Research programs/trials by providing clinical strategic and tactical leadership as the Country Clinical Development representative. • May work across several countries. • Gathers, informs, and acts on clinical/medical/scientific insights for clinical trial concept sheets/protocols, Informed Consent Forms (ICFs) and other relevant clinical documents to optimize clinical trial implementation. • Drives the identification and involvement of qualified investigators with greatest recruitment potential, identifies clinical recruitment hurdles and drives clinical recruitment activities to overcome these hurdles. • Accountable for adherence to safety standards and clinical data quality in the country by providing general clinical/medical support for trial related safety findings. • In close collaboration with other country functions (e.g., clinical trial operations, Medical Affairs, Patient Engagement, and Patient Access) actively contributes to successful allocation, fast clinical trial start-up, timely recruitment, early identification of potential delays, and development and implementation of mitigation plans. • Validates study designs, is accountable for, and makes the final decision on the clinical/medical trial and program feasibility of implementing a clinical trial protocol based on medical/clinical practice and analysis of the competitive environment in the country. • Actively contributes to scientific/clinical/medical aspects of the start-up phase to ensure fast clinical trial site start-up. • Provides clinical/medical expertise to clinical trial operations team members and clinical trial sites for Institutional Review Boards (IRB)/ Ethics Committee (EC) interactions. • Decides on site/Country-specific scientific/clinical/medical content of the Informed Consent Form(ICF) as needed and ensures appropriateness of patient suitable language. • Provides scientific/clinical/medical expertise during interactions with Country/Cluster external Experts (e.g., Regulatory Authorities, Medical Experts, Advisory Boards, Patient Advocacy Groups, etc.). • Building disease area expertise, especially for new/rare indications. • Provides robust indication, compound, and protocol training to the clinical operations team in the country, especially to the Clinical Research Associates, and other country line functions as needed. • Supports planning, implementation, and follow-up of scientific/clinical/medical components of Regulatory Authority inspections and internal audits. • Reviews and resolves Country trial-related scientific/clinical/medical issues/questions. If necessary, initiates the discussion with the Global Clinical Development team. • May be involved in reviewing the clinical/medical aspects of clinical trial Serious Adverse Events (SAEs) occurring in the Country and supports the patient safety team, and Global as needed to ensure high quality of clinical/medical information. • Follows-up with the Investigator for additional clinical/medical information or clarifications for AEs and SAEs and provides clinical/medical expertise for safety amendments, Investigator Notifications (INs), Urgent Safety Measures (USM), etc. as needed.

Requirements

• Advanced degree (Doctorate) required, MD is preferred. • Also open to PhD, PharmD, DO. • Specialty training in Oncology Radiation or Nuclear Medicine is required. • Proven track record of clinical experience in and scientific contributions to your field of expertise. • Ideally, 3 years of clinical development experience in the pharmaceutical industry or clinical practice. • Sound understanding of the overall clinical development process, and ICH/GCP principles. • Ability to manage a study from the scientific/medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex scientific/clinical/medical/operational issues. • Ability to lead effectively by communicating well, motivating a cross-functional team, and handling and delegating responsibilities. • Demonstrates a knowledge of how to adequately review and read a protocol to understand specifics of study design and answer questions regarding the trial. • Applies a detailed understanding of the drug in question to provide medical context as it relates to disease processes, populations, and standards of care. • Ability to assess the feasibility of implementing the protocol based on Country/Cluster medical practice and sound understanding of the overall Clinical Development Plan. • Demonstrates a high level of understanding of the protocol to train others, including site personnel. • Demonstrates an understanding of the protocol to evaluate compliance on the part of the Investigator/site staff/study participant and any patient safety issues. • Demonstrates an understanding of Regulatory requirements and internal policies, procedures, and guidelines pertaining to clinical trials. • Applies knowledge of Regulatory/industry requirements to work in a Country regulated environment. • Provides clinical, medical, and scientific expertise to facilitate the safe use of product(s) in clinical trials. • Applies safety expertise to answer clinical trial site safety questions and provides required information to Country/Global where appropriate. • Applies clinical/medical expertise to provide prompt review and follow-up on all SAEs and other safety documents relevant for clinical trial sites.