Assoc Clinical Research Medical Director, CRM

　　Job ID

　　390667BR

　　Jan 23, 2024

　　USA

　　About the Role

　　Disease Area: CRM (Cardiovascular, renal, metabolic)

　　Remote Position

　　The Associate Clinical Research Medical Director provides clinical strategic and tactical leadership in the country to support GDD trials and selected NIBR trials, clinical development plans which change the world, concept sheets/protocols and other clinical documents.

　　•Closely collaborates with the Trial Monitoring Organization and Medical Affairs to ensure successful allocation, fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and mitigation plan

　　•May lead medical/clinical discussion with local regulatory interactions as needed (CTA, NDA meetings, label discussions, post-approval commitments etc.)

　　•Cooperates with local functions such as e.g. Medical Affairs, Patient access to identify and involve qualified investigators with recruitment potential and relevant key experts for clinical development in order to leverage the value of the assigned project(s) in the context of the investigational product(s).

　　•Drives implementation of innovative ways running clinical trials

　　Major Accountabilities:

　　Provide clinical development and indication expertise specific to a country and drives together with the local TMO organization execution of clinical trials with high quality and in planned timelines:

　　•Closely collaborates with the Trial Monitoring Organization to ensure fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and robust recruitment mitigation plan. Co-own start-up phase and the recruitment plan for development clinical trials with the local TMO organization.

　　•Provides robust indication and protocol training to CRAs and CPMs, and other functions in the country as needed

　　•Provide protocol, Risk management plan & disease training as appropriate, and externally at Investigator’s Meetings or scientific venues to support recruitment and trial awareness.

　　•Assess the clinical feasibility of implementing a clinical trial protocol based on regional/local medical practice using physician interviews, local databases (RWE, payer data, patient association feed-back, etc.) and analysis of the competitive environment

　　•Provide medical/clinical assistance to TMO and site for IEC/IRB Interactions

　　•Review country or site-specific Informed Consent Forms (ICF) and ensure accuracy of translation of information related to Development clinical trials when translated into the local language, including the patient narrative where appropriate

　　•Support Ministry of Health interaction (or local Board of Health) as needed

　　•Support Regulatory Affairs, Health Economics, Drug safety and epidemiology and Medical Information with medical/clinical input as appropriate as this relates to global development clinical trials.

　　•Support planning, implementation and follow-up of regulatory agency inspections and internal audits

　　•Review and resolution of local medical issues / questions – if necessary, support the discussion of issues to global teams.

　　•Perform local AE review for development compounds and provide general medical support for safety issues:

　　o Provide medical expertise support to pharmacovigilance activities

　　o Responsible to review the medical aspects of clinical trial SAEs occurring in the country and support patient safety team, if needed

　　o Follow-up with the Investigator for additional information or clarifications as needed

　　o When necessary, provide medical expertise to Clinical Operations activities for safety amendments, INs, etc

　　•May be called upon to provide clinical/medical strategic and tactical input into clinical development plans and protocol designs at a global level. May also serve as Country representative in Regional/Global feasibility team. Identify high quality local/regional datasets (e.g. registries etc) which could be used to drive innovative study designs or support recruitment.

　　•Drive all scientific activities in adherence to GCP (Good Clinical Practices), and in line with ICH (International Conference on Harmonization) and local regulations

　　•Participation in Early product planning process to ensure that TMO trials conducted optimize cross-functional country strategy

　　•Participate in global working groups to support and improve processes for the CD&A/CRMA Line function

　　• Support safety and peer to peer clinical expertise discussions that are under the role of the MD

　　Diversity & Inclusion / EEO

　　We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

　　Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

　　Novartis: e-mail [email protected] or call +1 (877)395-2339

　　Sandoz: e-mail [email protected] or call: +1-609-422-4098

　　Role Requirements

　　• Scientific degree (medical degree highly desirable) Trained in relevant aspects of clinical drug development including GCP, local regulatory requirements and data privacy laws. RWE experience. Subspecialty training desirable, but not required.

　　• Speaks and writes English

　　• Ability to manage a study from the medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex-clinical / medical / operational issues

　　• At least 3 years of clinical development experience in the pharmaceutical industry or in clinical practice

　　• Sound understanding of the overall clinical development and ICH/GCP

　　• Disease area experience highly desirable

　　Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

　　Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

　　Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

　　Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $222,400 and $333,600/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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　　Division

　　Development

　　Business Unit

　　CLINICAL DEVELOPMENT DEV

　　Location

　　USA

　　Site

　　East Hanover, NJ

　　Company / Legal Entity

　　Novartis Pharmaceuticals

　　Functional Area

　　Research & Development

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No