Associate Clinical Development Medical Director
Associate Clinical Development Medical Director
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Job Description
Band
Level 5Job Description Summary
About the role:In this role you will be responsible for the scientific and medical strategy of assigned China-focused clinical trial(s) responsible for medical and scientific monitoring and reporting of quality data. May take on the duties and responsibilities of the Global Assoc. CDMD role. A senior clinical leader responsible and accountable for quality medical strategy at China clinical programs level.
Job Description
Key Responsibilities
As the Medical Lead for China-focused clinical trials provides clinical leadership medical and scientific strategic input and contributes to the development of trial related documents (e.g. Clinical Trial Protocol informed consent form case report forms data monitoring committee charters data analysis plan clinical study reports publications) for assigned clinical trial(s) consistent with Integrated Development Plan (IDP); develops materials for trial-related advisory boards data monitoring committees investigators meetings and protocol training meetings for local medical organization
In collaboration with integrated Clinical Trial Team (iCTT) members: Ensures direct medical support of trials as needed and may act as medical monitor; Conducts ongoing medical and scientific review of clinical trial data; Manages patient safety and reports on trial data to safety and clinical boards (e.g. Safety Management Team (SMT) GCT GPT); Provides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs) publications and internal/external presentations
Together with Patient Safety ensures continuous evaluation of drug safety profile including safety monitoring of clinical studies and signal detection from post- marketing surveillance
Provides medical and scientific input and contributes to clinical sections of program level regulatory documents (e.g. Health Authority briefing books safety updates submission dossiers and responses to Health Authorities)
Supports Therapeutic Area Head (TAH) or GPCH with contributing to peer-review of IDPs CTPs and other clinical documents as needed; Supports development of the disease area strategy for China leads or serves on China work streams to improve clinical development process acts as Subject Matter Experts for standard operating procedures or trainings and/or contribute to other cross-functional or Clinical Development line function initiatives
Responsible of medical/scientific training for relevant Novartis stakeholders on the disease area and compound/molecule
Contributes to talent and career development of China CD associates through on- boarding coaching and/or mentoring support; and may contribute to the performance evaluation of China clinical trial team members; Contributes to China GDD initiatives (e.g. process improvement training local SOP development other development unit line function initiatives)
Takes on special task assigned by the line manage
Commitment to Diversity and Inclusion / EEO:
Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
Essential Requirements:
Medical Degree is required and more than 5 years clinical experience is preferred
Advanced disease knowledge is preferred with proven ability to interpret discuss and present efficacy and safety data relating to clinical trial(s) or program level
Strategic thinking by actively seeking information to develop optimal clinical development strategy for registration
Demonstrated ability to establish effective working relationship with key investigators
Working knowledge of Good Clinical Practice (GCP) clinical trial design statistics and regulatory and clinical development processes
Strong interest/experience in coaching less- experienced associates and/or be able to function effectively as a medical leader in a cross functional team
Strong learning agility; Strong interpersonal skills; Strong negotiation and conflict resolution skills; Proven ability to work independently in a cross functional team setting
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart passionate people like you. Collaborating supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together and Rewards: Read our handbook to learn about all the ways well help you thrive personally and professionally: and Accommodation:
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to perform the essential functions of a position please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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Skills Desired
Clinical Trials Data Analysis Data Monitoring Drug Development Drug Discovery Medical Strategy People ManagementRequired Experience:
Director
Employment Type
Full-Time
