Alios BioPharma, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Early Clinical Development Lead (eCDTL) to be located in South San Francisco, CA. This position may also require up to 20 % travel
Johnson & Johnson's Family of Companies are dedicated to addressing and solving the most important unmet medical needs of our time, including: oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.
The Early Clinical Development Lead will provide leadership for one or more early Clinical Development Teams (eCDT) in the Infectious Disease Therapeutic Area from NME declaration through Phase 2a. The eCDTL will lead, oversee and contribute to the development of a pre-clinical and subsequent clinical development plan and areas of responsibility in (but not limited to) planning and executing of:
- Pre-clinical plans to support the initiation of clinical trials in humans
- Clinical programs conducted within timelines and budgets while ensuring regulatory compliance;
- CMC strategy to support CDP
- Regulatory strategy to support CDP.
- Contribute to the development of budgets and resource forecasts for all relevant pre-clinical and clinical development activities.
- Matrix management of the eCDT in their area of responsibility to ensure high quality execution of CDP including adherence to timelines and budgets
- Interact with other groups outside of the eCDT to ensure input into CDP where appropriate.
- Interact with other groups outside of the eCDT to ensure that appropriate resources are available to enable the CDP and that other departments are aligned with the CDP.
- Participate in strategic planning activities coordinated via the Disease Area Strategy (DAS) group
- Ensure that project key project milestones/strategy are communicated to the wider teams and endorsed by senior management.
- Ensure clinical development programs are tracked and communicated in a consistent and effective manner
- Interact with the TA’s Senior Leadership Team to ensure that the eCDT’s plans are aligned with department goals and within anticipated budgets
- Ensure smooth transition of compound(s) from early development into late development
- A minimum of a Master’s Degree is required.
- An advanced degree (PhD or MD) strongly preferred.
- A minimum 8 years’ experience in a relevant therapeutic area, with strong knowledge in Infectious Diseases is required.
- Experience in early phase clinical drug development is required
- Experience of regulatory interactions is preferred
- Demonstrated ability to work effectively with highly functional teams is required.
- Experience developing antiviral compounds in an early development setting is strongly preferred
- Self-motivated and able to work independently with minimal supervision is required
United States-California-South San FranciscoOrganization
Alios BioPharma, Inc. (6224)Job Function