Director, Medical Operations and Controls

Overview

Imagine\u2026 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives.

This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapy are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

We use cutting-edge technology to turn promising gene therapies into proven treatments beginning with SMA but also focusing on Rett Syndrome and Friedreich's Ataxia.

Imagine the lives you could transform by joining the Novartis Gene Therapy team.

The Director, Medical Operations and Controls, provides Medical Governance of regulated activities and GxP expertise to written standards and communications within the Global Medical Affairs (GMA) organization and ensure understanding.

Responsibilities

• Implementation of industry best practices, in collaboration with the Global Governance Office and Novartis Pharma Medical Affairs governance teams.
• Ensures that global, regional and country GxP gaps and risks are addressed and mitigated.
• Supports GMA's adherence to obligations set forth in the Novartis Corporation CIA
• Oversee and monitor local audit & inspection readiness and execution, in close collaboration with local QA and Ethics, Risk and Compliance for GMA
• Provides relevant updates on global governance initiatives and guidelines to the GMA Leadership team related to:
  • Recent review and revision of Novartis GTx SOPs and Global Guidances, as applicable
  • Give input or support annual Risk assessment, provide audit support and the implementation of corrective actions, and conduct business lead monitoring (as required), and facilitate corrective action plans
  • Ongoing monitoring of the performance of Novartis GTx GMA activities, taking into account risk assessment, prior audit findings and other factors for effective resource deployment, and taking appropriate steps to improve effectiveness.
  • Current internal and external audits and the measures taken to oversee these reviews
• Supports in identifying gaps through risk management
• Lead the End-to-End medical governance of regulated activities (Interventional and NIS/RWE, IIT, MAP, RC), in alignment with Medical Affairs strategy and priorities.
• Represent GMA as a member of the Novartis Medical Governance Working Group
• Proactively participate in regional/global MGL Network and other forums for ensuring continuous improvement (e.g. co-collaborative team to develop materials for onboarding on processes, to develop "How To" materials, review of SOP/guidelines, involvement in Tools development associated to medical projects and support decision making.
• Understand the systems that enables key governance processes in order to give advice and guidance to activity owners.
• Provide Governance support, advice, coaching and expert input to the GMA activity owners and teams.
• Oversees GMA procedures and guidance.
• Establish and manage a process for creating and maintaining GMA procedures and guidance within Medical Affairs and ensure alignment with other key business functions.
• Supports development of new or revised processes, procedures and guidance required to operate in a new and changing environment.
• Directs written standards established in all Medical Functions reflective of standards and responsive to internal and external law, regulation, and guidance.
• GTx GMA Lead for integration of Novartis procedures and guidance related to and owned by Medical Affairs
• Supports GMA functional areas to ensure effective processes are established and comply with applicable policies, laws, and regulations.
• Provides leadership, guidance, operational oversight and standards to maximize innovation and mitigate risk.
• In collaboration with GMA Training, develops and implements strategic and dynamic training on GMA procedures and guidance, and other Novartis compliance requirements
• Drives implementation of change management initiatives
• Other related duties as assigned.

Qualifications

• Bachelor degree in life science/healthcare with 10 years pharmaceutical industry, typically in clinical research/medical affairs, or medical education agencies or equivalent education/degree.
• Experience writing guidance documents and audit procedures.
• Excellent verbal and written communication skills.
• Ability to lead within a cross-functional team.
• Business knowledge and understanding of commercial marketing.
• Ability to work across cultures.
• Demonstrated experience in working with others to achieve organizational objectives including the ability to anticipate and adapt, own and or/work group tactics to support changing business needs.
• Ability to build relationships, collaborate and influence across a matrix organization.
• Business acumen - insightful understanding of the industry and how it is evolving.
• Must be self-aware and open to feedback.
• Desired talent must have a collaborative mindset and curious nature.
• Action-oriented. Able to "get things done" within the organization.
• Values collaboration and teamwork over self-interest.
• Possesses a spirit of confidence and self-reliance.
• Ability to express key perspectives in a way that is succinct and compelling to others.
• Medical Affairs and/or Compliance Department experience.

The level of this position will be based on the final candidate's qualifications.

Why Novartis?

769 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 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!

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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