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Global Program Diagnostics Director

Novartis Pharmaceuticals Corporation

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Location:
Cambridge, MA
Posted Date:
4/18/2014
Position Type:
Full time
Job Code:
126115BR
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The Global Program Diagnostic Director leads and oversees all aspects of one or more Diagnostic Development Programs with a predominant focus on ensuring regulatory approval, technical market access and optimised commercial value. This involves responsibilities for deliverables, quality, time and costs for the program(s). Provide strategic leadership to the program(s) and the Global Program Head of the drug project, comprising of all relevant technical and commercial disciplines and regions. Define the vision, the target test profile, the key claims portfolio and the platform strategy, the overall development strategy and plan (based on regulatory and commercial/consumer requirements/needs) that overall lead to a new diagnostic test. Drive and steer the implementation of the Program's strategic plan in close collaboration with the Global Program Head for drug program and within the accepted timelines, budgets and resources at the required quality level. Identifies, resolves and escalates resource issues. Avoid strategic and operational crises by proactively identifying and managing potential risks to the program(s). In case issues cannot be avoided, ensure that they are being resolved employing the full technical and strategic expertise and experience of the organization thus limiting negative impact on the program(s). Coordinates and oversees execution of diagnostic/technology strategy for diagnostic test; if in a companion setting in alliance with the responsible GPH (pharma). Represents the Diagnostic Development team internally and externally with objective advocacy of the program’s potential and transparent disclosure of program risks. Jointly with the Global Line Function, approves staffing of Diagnostic program team members. Recommends when to roll-off team members. Sets goals and appraises performance of diagnostic development team members. Compliance to applicable US and international Medical Device regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, 93/42/EEC, 98/79 EC, and the requirements of the Novartis CDx Quality Management System.
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Note: This position is for either a Director or Executive Director. The level at which this position will be filled will be commensurate with the experience of the candidate to whom the job is offered.
Minimum requirements  Doctoral in life sciences or chemistry, or MBA with equivalent experience in life sciences. Fluent English (written and oral).
1. 15 years industry experience
2. 5+ years multi/cross functional leadership experience within an Oncology business unit.
3. International drug or diagnostic development project functional leadership
4. Have an advanced understanding of the diagnostic development process and programs.
5. Provide thought-leading insights to the competitive environment and internal partner interfaces 6. Sound knowledge of international customs and business practice
7. Hands on experience with a major submission and regulatory review process
8. Proven people leadership capabilities
9. Model natural leadership characteristics
10. Expert leadership skills demonstrated in GPT, in staff management role or in other
organizational assignments. Expert skills to facilitate/optimise contribution of team members
as individuals and members of cohesive team.
11. Strong interpersonal and communication skills for bridging scientific and business participants,
for negotiating timelines and for effective international collaboration.
12. Outstanding verbal and written communications.
13. Diagnostic experience is an advantage
14. Results driven

Novartis is an EEO employer M/F/D/V. This position will be filled at a level commensurate with experience.

Requirements

Doctoral in life sciences or chemistry, or MBA with equivalent experience in life sciences. Fluent English (written and oral).
1. 15 years industry experience
2. 5+ years multi/cross functional leadership experience within an Oncology business unit.
3. International drug or diagnostic development project functional leadership
4. Have an advanced understanding of the diagnostic development process and programs.
5. Provide thought-leading insights to the competitive environment and internal partner interfaces 6. Sound knowledge of international customs and business practice
7. Hands on experience with a major submission and regulatory review process
8. Proven people leadership capabilities
9. Model natural leadership characteristics
10. Expert leadership skills demonstrated in GPT, in staff management role or in other
organizational assignments. Expert skills to facilitate/optimise contribution of team members
as individuals and members of cohesive team.
11. Strong interpersonal and communication skills for bridging scientific and business participants,
for negotiating timelines and for effective international collaboration.
12. Outstanding verbal and written communications.
13. Diagnostic experience is an advantage
14. Results driven

Novartis is an EEO employer M/F/D/V. This position will be filled at a level commensurate with experience.

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