Vice President, Technical Research & Development Cell & Gene Therapy (Global Head)

Location
Durham, NC, US
Posted
Jul 10, 2021
Ref
6175
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
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 are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

The Vice President, TRD Cell & Gene Therapy leads the Global Cell and Gene Therapy (CGT) function for Technical Research Development (TRD), comprising of multiple units in various locations and a pilot plant facility. Shape and develop its strategic direction and drive operational excellence in line with TRD Biologics & CGT vision and strategy. Represent TRD on cross-divisional Cell Therapy and Gene Therapy leadership teams. Acts as an ambassador for the Novartis Culture - Inspired, Curious and Unbossed.

Responsibilities
  • Leads Global Cell & Gene therapy function in TRD Biologics & CGT for end-to-end CGT development and clinical manufacturing, comprising of multiple units in various locations (multiple countries) and one pilot plant.
  • Develop, implement, drive and regularly refine the global strategy for CGT development and clinical manufacturing in line with TRD Biologics & CGT vision and strategy, as well reflecting customer needs and expectations.
  • Build and maintain an effective, agile, high performing global organization that consistently supports existing and future product portfolio. Ensure efficient global processes and business practices, drive continuous, global knowledge exchange and lessons learned.
  • Ensure optimal resource allocation and appropriate make vs. buy decisions in alignment with project priorities, technology strategy and business impact in line with TRD Biologics & CGT governance processes.
  • Drive decisions on DS/DP production slot allocations for manufacturing (internal & external), while fully supporting clinical demands.
  • Closely work and align with partner functions within Biologics & CGT.
  • Establish and maintain strong business relations and interfaces to key partners and stakeholders such as Novartis Technical Operations (NTO), Novartis Institute Biomedical Research (NIBR), Global Drug Development (GDD), Oncology, Pharma, Quality, Procurement, RA CMC etc.
  • Proactively shape the CGT development environment by fully utilizing internal and external know-how as well as cutting edge technologies and approaches, continuously push and operationalize innovation and data & digital initiatives in line with TRD Biologics & CGT strategy.
  • Achieve a true culture of collaboration, empowerment, innovation, diversity and inclusion, trust, high performance and continuous learning.
  • Drive talent acquisition and retention, succession planning and professional development of all associates to fully unleash their potential.
  • Actively coach and develop direct reports.
  • Ensure compliance with all relevant regulations (e.g. ISEC, GMP and HSE) and establish related accountabilities within the organization.
  • Ensure high quality source documents and dossier modules (where applicable) for regulatory submissions.
  • As a member of the Biologics & CGT global leadership team, actively contribute to TRD Biologics & CGT strategy, vision and operations; represent Biologics & CGT at cross-functional decision-/governance boards (as appropriate).

Job Dimensions:
  • Leads ~300 direct and indirect reports across 7 sites in 3 countries.
  • Financial responsibility: ~190 m USD (internal & external cost), ~22 m USD CAPEX (depending on investment strategy).
  • Impact: Key global function in GDD for development of CGT including cutting edge process development, formulation technologies and packaging. Manufacturing of clinical supplies (phase I to III) and process transfer to production globally. Brand expansion and maximization via LCM (life-cycle-management); supporting Pharma, Oncology, and NIBR.

Qualifications
  • Minimum Bachelor's degree in technical or scientific area, preferentially pharmaceutical sciences.
  • Minimum of 15 years of experience within the pharmaceutical industry, at least partially in the field of Cell & Gene Therapies.
  • Minimum of 8 years of experience in leadership positions.
  • Excellent knowledge of the drug development process including process commercialization and regulatory strategy.
  • A proven track record in leading and engaging people in a multicultural, global environment.
  • Proven ability to create and establish strategy and vision in organizations.
  • Ability to foster and implement focused innovation.


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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