Director, New Therapeutic Products

United States, Walkersville (Maryland)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza has an exciting opportunity to join our Personalized Medicine (PerMed) team as the Director, New Therapeutic Products. This individual will be responsible for developing long-term disease area strategies to assure the right portfolio as well as the best clinical and launch/commercialization strategies. Primarily focus on Immune Cell Therapies and Rare genetic Diseases. Work closely with both internal groups as well as with external collaborator, clients and end users to assure clinical program alignment and asset optimization. Guide the business unit in terms of strategically thinking about clinical portfolio and how this portfolio will succeed in commercial phase.

Key responsibilities:

  • Lead the development of collaborative co-development of multiple therapies to determine where and how Lonza should engage to succeed 
  • Collaborates with business development to build-up a strong pipeline with a detailed market analysis
  • Lead the strategic direction of clinical programs through clinical phases and into commercialization
  • Jointly develop clinical development plan, clinical study protocol, clinical study report
  • Leads the delivery of the clinical study(s) from concept to final CSR and to deliver on budget, time, project standards, quality and scientific standards
  • Ensure sponsor oversight
  • Develops and manages effective risk management/mitigation plans
  • Lead interactions with external entities including regulatory agencies, preferred partners/suppliers and external collaborators
  • Responsible for oversight of CROs and other clinically outsourced third party vendors
  • Use insights gained from engagement with patients, physicians & payers to ensure that programs are developed to deliver a competitive value proposition at launch
  • Ensures the long term commercial viability of therapies
  • Develop strategic analysis of how clinical assets are manufactured, launched, and are successful across geographies  
  • A leader & collaborator working well within a matrix organization, together with: Clinical Dev., R&D, PD, Ops., QA and RA

Key requirements:

  • Ph.D. in Immunology, Biology (or related discipline); MBA preferred
  • Significant experience in Personalized Medicine, Cell and/or Viral Therapy
  • Proven experience of clinical programs in the cell therapy space
  • Good understanding of therapy pricing and commercialization
  • Drug development experience
  • Extensive experience in leading studies/programs in clinical development
  • Proven experience in driving operational delivery to timelines, cost and quality
  • Knowledge of ICH-GCP principles
  • Project Management experience within the context of Clinical Drug Development
  • Strong collaborative communications skills
  • Experience in providing clear requirements for external contracts
  • Experience in selection of external providers and development/review of contracts
  • Proven oversight of external providers
  • Good ability to perform therapeutic market analysis
  • Good understanding of clinical center settings
  • High degree of thought flexibility
  • Good communication and negotiation skills
  • Ability to find win-win solutions and to work closely with business and academic partners

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. 

Reference: R36376