Clinical Research Medical Director (REMOTE)
- East Hanover, New Jersey, United States
- Closing date
- Apr 11, 2023
- Health Sciences, Clinical Research, Medicine
- Position Type
- Full Time
- Job Type
- Organization Type
22. The number of dedicated and inspired professionals in the US Clinical Execution team who are empowered to ask new questions and make bold decisions to bring lifesaving medicines and treatments to patients. Come join our curious and supportive team and make an impact on patient’s lives every day.
You will provide clinical, strategic, and tactical leadership in the country to support GDD trials, selected NIBR trials, and clinical development plans (CDPs), concept sheets/protocols and other clinical documents.
Closely collaborate with Operations and Medical Affairs to ensure 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.).
Collaborate with local functions such as Medical Affairs, Patient Access, etc., to identify and involve investigators and key experts for clinical development to acquire the value of the project(s) in the context of the investigational product(s).
Drive implementation of innovative ways running trials.
This includes, but is not limited to the following:
Provide development and indication expertise specific to a country, and drive together with Operations, the execution of clinical trials with high quality and within timelines:
1. Provide indication and protocol training to CRAs and CSEs, and other functions.
2. Provide protocol, Risk management plan, and disease training internally, and, externally at Investigator’s Meetings or venues to support recruitment and trial awareness.
3. Assess the feasibility of implementing a trial protocol based on regional/local medical practice using physician interviews, databases (RWE, payer data, patient association feedback, etc.) and analysis of the competitive environment.
4. Support Regulatory Affairs, Health Economics, Drug Safety and Epidemiology, and Medical Information for developing global trials.
5. Review and resolve local medical issues & questions. As needed, support the discussion of issues to global teams.
6. Perform AE review for compounds and provide general medical support for safety issues including but not limited to: supporting the Safety team; follow-up with the Investigator for information or clarifications; provide medical expertise to Clinical Ops for safety amendments, INs, etc.
7. Drive all scientific activities in adherence to GCPs, ICH, and local regulations
8. Participate in global working groups to support and improve processes for the CD&A/CRMD Line function; co-own start-up phase and recruitment plan with local TMO organization.
The pay range for this position at commencement of employment is expected to be between $257,600 and $386,400 year; however, while salary ranges are effective from 1/1/23 through 12/31/23, 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.
Diversity & Inclusion / EEO
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.
1. Medical degree required; Neurologist with neurodegenerative experience strongly preferred
2. Have 5+ years of clinical development experience in the pharmaceutical industry, per above description, with sound understanding of the overall clinical development process. preferred
3. Showcase expertise in Protocol Execution, Regulatory & Compliance process, and Safety Monitoring.
4. Trained in aspects of clinical drug development including GCPs, ICH, local regulatory requirements, data privacy laws and RWE experience.
5. Display experience handling a study from the medical/clinical perspective, proven competency to problem solve, and mediate complex clinical / medical / operational issues.
6. Agility to move across varying therapeutic areas and indications.
At Novartis, we are reimagining medicine.
Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.
Novartis has one of the industry’s most competitive pipelines. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.
We have entered an exciting era in health and biomedical innovation. Powered by our incredible colleagues, supported by our flexible-hybrid working model, new AI powered learning, personal growth and career platform and a refreshed commitment to diversity, equity & inclusion, we are well-poised to help lead this transformative moment for our industry and for ourselves. Join Us!
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