Novartis Biologics Unit is Novartis’ dedicated biologics discovery and development organization. Over the past several years, Novartis has had the greatest number of new molecular entities approved by the FDA for clinical use in the US. Novartis is expanding its biologics capabilities to leverage its deep disease area expertise and innovative internal research, as well as discoveries made at leading academic institutions and biotechnology companies.
Novartis has established the Biologics Unit to accelerate the advancement of its rich biologics pipeline. This startup unit is seeking entrepreneurial leaders and top scientists and technicians at all levels to build a development organization dedicated to delivering therapies that improve the lives of patients.
Novartis are looking for a Principal PK/PD Expert to negotiate an optimal PK-PD strategy for early and full development in liaison with appropriate line functions and with Management input as appropriate. Responsible for the PK, PK/PD and M&S component of study protocols, reports, project summaries and development plans within agreed timeframes and which meet regulatory requirements. Prepare appropriate responses to HA inquiries (globally). Interpret and present project related study results.
Major Activities:
1. Facilitates constructive collaboration within and between project teams.
2. Identifies potential project hurdles, suggests solutions and establishes priorities and contingency plans.
3. Responsible for the compilation, seeking of approval and updating of specific elements of development plans to support the project plans.
4. Monitors study timelines, objectives and budgets, ensures accuracy of project plans, assures rapid and effective communication of data to early project team.
5. Independently manages and coordinates relations with regulatory authorities, line function, unit heads and directors.
6. Leads or participates in sub-teams and leads specific teams.
7. Manages the preparation/presentation of all internal and external (e.g. Investigator’s Brochure, IND, CTD) documentation.
8. Maintains scientific and regulatory expertise in the field (e.g. training courses, external meeting attendance).
9. Evaluates in-licensing opportunities and carries out Due Diligence activities as required.
10. Advises and mentors project team members.
11. Chairs project review meetings.
12. Contributes to performance appraisal and development plans for full and part-time project team members.
The ideal candidate will have the following skills and experience
PhD in natural /biological sciences, DVM, PharmD or equivalent with biological background or equivalent training on the job.
- Minimum 5 years in drug development functions with a minimum 5 years experience as Senior PTR (IPTs or early development teams) within a relevant LF in industry or regulatory agency.
- Possesses a broad knowledge of overall development aspects outside own area of expertise.
- Proven record as team player/leader with superior negotiation skills.
- Ability to manage conflicting expectations in a matrix environment.
- Excellent project management skills.
- Excellent knowledge of drug development guidelines.
- Ability to coach and advise colleagues in project related matters.
- Managerial skills to provide input into performance plans and appraisal of PTR and/or Senior PTR.
- People management skills (responsibility or co-responsibility for appraisal) in a matrix environ-ment or for direct reports.
- Fluent English (oral and written).