347726BR
Jun 28, 2022
USA

Job Description

20. 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 unbossed team and make an impact on patient’s lives every day.

Job Description:
You will provide clinical, strategic, and tactical leadership in the country to support GDD trials, selected NIBR trials, and clinical development plans (CDPs) which change the world, concept sheets/protocols and other clinical documents.
Closely collaborate with the Trial Monitoring Organization (TMO) 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.).
Cooperate 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.

(Major accountabilities)
This includes, but is not limited to the following:
Provide development and indication expertise specific to a country, and drive together with TMO, 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.

"This role is open to Remote Locations"

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.

Minimum Requirements

Requirements:
1. PhD or PharmD degree is required. Medical degree highly desirable MD/DO
2. Have 5+ years of clinical development experience in the pharmaceutical industry, per above description, with sound understanding of the overall clinical development process.
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.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis

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Global Drug Development
CRMA GDD
USA
East Hanover, NJ
Research & Development
Full Time
Regular
No
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347726BR

Clinical Research Medical Director

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