347250BR
Jun 16, 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!


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.


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:

• Provide indication and protocol training to CRAs and CSEs, and other functions.
• Provide protocol, Risk management plan, and disease training internally, and, externally at Investigator’s Meetings or venues to support recruitment and trial awareness.
• 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.
• Support Regulatory Affairs, Health Economics, Drug Safety and Epidemiology, and Medical Information for developing global trials.
• Review and resolve local medical issues & questions. As needed, support the discussion of issues to global teams.
• 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, Investigator Notifications, etc.
• Drive all scientific activities in adherence to GCPs, ICH, and local regulations
• 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.

-----------------------------------------------------------------


-----------------------------------------------------------------
While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected].

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

This position may be based remotely anywhere in the US. (there may be some restrictions based on legal entity).
Please note that this role would not provide relocation as a result. The expectations of working hours and travel (domestic and/or international) will be defined by the Hiring Manager. This position will require ~30% travel
---------------------------------------------------------------------

What you'll bring to the role:

Education:
• PhD or PharmD degree is required. Medical degree is highly desirable (MD/DO)

Experience:
• Have 3+ years of clinical development experience in the pharmaceutical industry, per above description, with sound understanding of the overall clinical development process.
• Showcase expertise in Protocol Execution, Regulatory & Compliance process, and Safety Monitoring.
• Trained in aspects of clinical drug development including GCPs, ICH, local regulatory requirements, data privacy laws, and RWE experience.
• Display experience handling a study from the medical/clinical perspective, proven competency to problem-solve, and mediate complex clinical / medical / operational issues.
• Agility to move across varying therapeutic areas and indications.

Skills:
• Expertise in both presentation and facilitation.
• Confident in influencing peers across the organization and ability to establish business partner relationships with collaborators.
• Operate effectively with the established divisional/functional & technical teams; work well with others in a team environment.

-------------------------------------------------------------------
Why Novartis?

766 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
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 tackle the world’s toughest medical challenges aggressively and ambitiously. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

---------------------------------------------------------------
Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusion workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.

-----------------------------------------------------------------
Join our Novartis Group Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

---------------------------------------------------------------
Accessibility and reasonable accommodations:

The Novartis Group of Companies are 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 application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
https://www.novartis.com/careers/careers-research/notice-all-applicants…
Global Drug Development
CRMA GDD
USA
East Hanover, NJ
Research & Development
Full Time
Regular
No
careers default image
347250BR

Associate Clinical Research Medical Director (Remote-US)

Apply to Job Access Job Account