Head, Clinical Projects CDMA
•Lead CDMA Project Team to be accountable for all aspects of assigned feasibility, confirmatory and post-registration clinical trials.
- Number of clinical trials depends on the workload, product pipeline in the franchise and complexity of the individual trials.
- Responsible for program level activities as assigned.
- Lead and manage group CDMA Project Leads to produce a high-performance team that is fully aligned with regards to experience and development needs.
- Accountable for ensuring high-quality, scientifically-sound clinical protocols and related documents that produce clear, decisive results.
- Lead and matrix manage the clinical trial aspect for project/program teams to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures; report study progress and issues with their resolution plan.
- Accountable for medical/scientific review of clinical trial data, final analysis and interpretation within clinical trial reports, publications and internal/external oral and written presentations.
- Accountable for developing realistic trial budget forecasts and for timely execution of clinical studies and for the reallocation of resources as required to meet targets.
- Forecast trial resource needs (headcount and external costs): accountable for the development, management and tracking of trial budget.
- Accountable for accuracy of trial information in all trial databases and tracking systems.
- Assess resource needs with program to ensure appropriate line function allocation.
- Contribute to the development of clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, regulatory submission documents, and responses to Health Authorities questions.
- Participate in the on-boarding and training of new CDMA staff and for mentoring new project/program team members as needed.
- Stay abreast of relevant literature and clinical practice norms for the project/program area(s).
Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information
alrpo EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements •Advanced degree or equivalent education/degree in life science/healthcare is required.
- Minimum 10 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies.
- Minimum 7 years people management and development experience required.
- Global people management experience is desirable.
- Well respected in eye care / research community
- Demonstrated ability to establish strong scientific partnership with key external collaborators.
- Proficient in MS Word, Excel, and PowerPoint
- Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process.
- Excellent written and verbal communication skills with successful presentation capabilities.
- Result oriented; quality work provided even when operating under tight timelines.
- Strong track record for being a team player and open for innovation.
- Previous experience in interactions with Health Authorities is preferable. Ability to manage multiple projects simultaneously.
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