Executive Medical Director Head, US Clinical Trial Excellence

Job Description

799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

The Executive Medical Director Head, US Clinical Trial Excellence is responsible for the strategic and medical oversight of all US Phase IIIB-IV trials, as well as providing insights to programs that involve US participation, registration, real-world evidence, implementation, digital, and post-approval studies. The position is key to the implementation of US CDMA data generation strategy within GCP/ICH and Regulatory requirements, developing simple and innovative clinical trial programs that reduces patient burden & improve efficiency, while maintaining patient safety, providing good communication and maintaining professional relationships with internal/external stakeholders.
Your responsibilities include, but not limited to:
o Provide recommendations and contribute trial expertise to meet the clinical trial goals of the business
o Provide strategic mentoring/supervision and physician oversight (as applicable) to Clinical Trial Leaders and advise medical directors regarding trial design and implementation, medical and safety review, site interactions, operational components, budgeting.
o Lead a cross functional review of all ongoing Phase IIIb/IV clinical trial data generated to define treads and assure patient safety, and assure appropriate actions to mitigate risk.
o Provide strategic input at scientific meetings, steering committee meetings, and external meetings, while fostering and developing strong relationships with investigators, sites, regulatory agencies and/or advocacy organizations.
o Identify and implement high value trial strategies for product life cycle development and expansion across the entire Novartis portfolio.
o Leverage strong scientific and medical rigor in the oversight of the development and launch of commercially viable products with well-planned trials, accounting for needs of external stakeholders
o Critical input into the ongoing and proposed clinical trials to drive US Medical strategy, aligned with Global Medical Affairs for development and marketed products.
o Actively communicate and liaise with BUs, local Medical Units, Medical/Clinical Trial Teams, HEOR, Regulatory, Field personnel, and patient advocacy to align trials from Global Medical Affairs or US- initiated perspective with US needs and strategy, while meeting needs of diverse set stakeholders.
o Provide recommendations and contribute trial expertise to meet the goals of the business
o Provide strategic mentoring/supervision and physician oversight (as applicable) to Clinical Trial Leaders and advise medical directors regarding trial design and implementation, medical and safety review, site interactions, operational components, budgeting.
o Lead a cross functional review of all ongoing Phase IIIb/IV clinical trial data generated to define treads and assure patient safety, and assure appropriate actions to mitigate risk.
o Provide strategic input at scientific meetings, steering committee meetings, and external meetings, while fostering and developing strong relationships with investigators, sites, regulatory agencies and/or advocacy organizations.
o Responsible to help lead and develop novel approaches related to study design and execution, site identification and drug access to facilitate Clinical Innovation.
o Develop and implement tools (such as templates) that are transferable amongst different trials and /or different groups within the Novartis organization that facilitate trial initiation/implementation.
o Define and implement processes ( e.g., safety review) to improve consistency of trial support across the US Pharma Medical Units and share Best Practices across USCDMA
o Oversight of the collaboration with Medical Directors and Operations team including providing guidance to insure trials meet timelines and budgets
o Member of the USCDMA Study Review Committee
o Ensure appropriate local processes in place for local Phase IIIb/IV clinical trials that are effective and in compliance with regulatory standards and aligned with global SOPs.
o Provides input into clinical trial budgets as needed
o Advise Clinical Trial Leaders regarding the conduct of the trial, tracking and oversight of progress and status. Ensure all operational aspects are on schedule for all US CDMA Phase IIIb and Phase IV clinical trials
o Facilitate internal audits and HA inspections as required. Assist in audit response and implementation of corrective actions following audits and inspections in relationship with Quality Assurance.
o Communicate effectively with Sr. Management reporting study metrics, departmental status, and team development.

EEO Statement
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

What you’ll bring to the role:
• MD, or DO, or Pharm. D or PhD degree with demonstrated clinical trial experience in the medical field is required
• ≥10 years of pharmaceutical industry experience in a medical function is required
• Strong academic background and Board Certification/Eligibility in Internal Medicine, or other medical specialty is preferred
• Experience in managing clinical trials is essential. Clinical trial medical/operational experience conducted in a pharmaceutical or equivalent environment is strongly preferred
• Firm working knowledge of GCP, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies designated for review by regulatory authorities is strongly preferred
• Strong knowledge of US health care system.
• Advanced knowledge of Medical Affairs experience, to include a well-documented history in medical development and of bridging proactive relationships among product development, clinical development and local medical teams.
• Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process

*This role will entail about 20% travel.

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 inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis 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

320288BR