Description
A successful and well funded bay area biotech is urgently seeking a GI development expert to join their team at Medical Director. This is an extremely crucial appointment as this person will be working closely with the VP of Clinical Development on developing various GI programs.Job Responsibilities:
- Lead the clinical strategic efforts for the GI programs
- Help lead and develop all protocols for the GI programs and work closely with the clinical investigators and the project teams
- Provide medical monitoring for company sponsored oncology trials
- Establish and lead efforts for publication planning and investigator sponsored trial program
- Lead advisory boards and investigator meetings
- Lead Clinical Research Teams, and play a very active role on project teams
- Prepare and deliver proposals, plans and updates to the governance committees at regular intervals and when requested
- Develop processes and standards that are in accordance with GCP and ICH guidelines to enable efficient and consistent clinical activities
- Work effectively with internal stakeholders (e.g. Biometrics, Research, Regulatory Affairs, CMC) and external stakeholders (e.g. Investigators, FDA, NCI) to ensure efficient execution of the clinical programs
- May be required to manage other clinical personnel as needed
Background and Experience:
- MD or equivalent with experience in GI research
- A minimum of 3+ years experience in drug development phase I-III in the pharmaceutical or biotech industry
- Thorough understanding of clinical GI research and the drug development process from phase I-III. Significant experience with later stage clinical trials, successful track record of NDA/BLA submissions, and experiences with FDA and ex-US regulatory authorities are highly desired
- Deep understanding of cancer cell biology and its application to clinical experimentation
- Thorough understanding of relevant nonclinical development in hem/onc area
- Strong implementation skills
- Substantial experience with developing clinical protocols and medical monitoring
- Must have good rapport with investigators and viewed as a peer to investigators; pre-existing relationships with global KOLs a plus
- Familiarity with ICH and other regulatory requirements related to clinical activities
- Strong and demonstrated effective leadership of multi-disciplinary teams including an ability to appropriately prioritize and resource to drive for results, use sound judgment in complex situations, to effectively influence and work with others at multiple levels within and outside the organization is required
- Ability to work independently within a defined strategic context, contribute to strategy and take initiatives and assess risks
- Excellent organizational, communication, and presentation skills
- Willingness to travel as needed
This is an in-house position with no possibility to work remotely or commute. If you are interested in learning more, please submit a copy of your resume to e.laidlaw(@)realstaffing.com or apply through this link.
If you have any questions please call Ellie Laidlaw at .