Newave Pharmaceutical Inc,
Global Clinical Trial (Executive) Director
Newave Pharmaceutical Inc,, New York, New York, United States
Home-based within the United States
Minimum 8–12+ years clinical operations experience
Minimum 3-5 years’ previous experience as a Global Clinical Trial Manager
Minimum
2
years
hematological
malignancies Phase
I-III clinical trials
experience required Previous
CRO
/
pharmaceutical
company /
biotechnology
company work experience
Newave Pharmaceutical Inc (Newave) is looking to hire a full-time Global Clinical Trial (Executive) Director in the US (remote city, work from home). Newave is a biotechnology company, located in Pleasanton, CA, dedicated to the discovery and development of small molecule oral therapeutics to treat cancer, infection, and autoimmune diseases.
Description SCHEDULE: full-time
Work Location: **This is a Work from Home position, and you can be located anywhere in the United States to be eligible for this role. East coast or central US is preferred.
Summary of Position: Responsible for management of multiple assigned clinical trials, phases 1, 2 and 3. Ensure clinical trials work completion to the set expectations, ensuring quality deliverables on time and within budget and in accordance with SOPs, ICH GCP, applicable laws, policies, and practices. Ensure effective and timely communication of study progress, issues, and plans for resolution of those issues. Provide leadership in the development of clinical trials and related documents. Work closely and effectively with cross-functional teams.
Duties You will plan, track, and run all activity throughout the clinical trials lifecycle, including deliverables from all functional areas and vendors to the trials scope You will develop clinical trials plans, timelines and status reports and communicates with all applicable team members in and outside the organization You will promote effective partnership among cross-functional teams and provide day to day direction for core team You will meet with team members on a regular basis regarding study tasks to ensure trials achievements You will serve as primary trials contact to the clinical sites You will handle clinical trials budget, communicate deviations from budget projections and propose solutions for budget deviations You will lead problem solving and resolution efforts. Provide dedicated and creative recommendations on how to meet goals and handle identified risks and deviations You will ensure that work is conducted in compliance with professional standards and SOPs, and meet quality and timeline metrics You will build and maintain strong pharmaceutical industry sponsor and organizational team relationships for the success of clinical trial management You will partner with other team members to initiate improvements to enhance the efficiency and the quality of the work performed on assigned clinical trials You may participate in proposal development
Qualifications You should have: Minimum 8–12+ years clinical operations experience Minimum 3-5 years’ previous experience as a Global Clinical Trial Manager or Project Manager for a CRO / pharmaceutical company / biotechnology company managing study timelines, deliverables and vendors Minimum 2 years’ Experience in hematological malignancies Phase I-III clinical trials Knowledge of FDA and or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies Prior CRA experience (preferred) Enjoy the fast pace in start-up company Able to respond to issues/problem quickly and resolve them in timely manner. Demonstrated leadership skills Able to work with team members with various background and experiences Bachelor’s Degree (4-year program) or higher It would be helpful if you had: Prior experience mentoring and/or training less senior team members Experience editing and managing the process of clinical trial document creation including protocols and informed consent statements
We would love to talk to you about this fantastic opportunity.
If you are highly qualified you will hear from one of our recruiters. We are actively interviewing so apply today.
2
years
hematological
malignancies Phase
I-III clinical trials
experience required Previous
CRO
/
pharmaceutical
company /
biotechnology
company work experience
Newave Pharmaceutical Inc (Newave) is looking to hire a full-time Global Clinical Trial (Executive) Director in the US (remote city, work from home). Newave is a biotechnology company, located in Pleasanton, CA, dedicated to the discovery and development of small molecule oral therapeutics to treat cancer, infection, and autoimmune diseases.
Description SCHEDULE: full-time
Work Location: **This is a Work from Home position, and you can be located anywhere in the United States to be eligible for this role. East coast or central US is preferred.
Summary of Position: Responsible for management of multiple assigned clinical trials, phases 1, 2 and 3. Ensure clinical trials work completion to the set expectations, ensuring quality deliverables on time and within budget and in accordance with SOPs, ICH GCP, applicable laws, policies, and practices. Ensure effective and timely communication of study progress, issues, and plans for resolution of those issues. Provide leadership in the development of clinical trials and related documents. Work closely and effectively with cross-functional teams.
Duties You will plan, track, and run all activity throughout the clinical trials lifecycle, including deliverables from all functional areas and vendors to the trials scope You will develop clinical trials plans, timelines and status reports and communicates with all applicable team members in and outside the organization You will promote effective partnership among cross-functional teams and provide day to day direction for core team You will meet with team members on a regular basis regarding study tasks to ensure trials achievements You will serve as primary trials contact to the clinical sites You will handle clinical trials budget, communicate deviations from budget projections and propose solutions for budget deviations You will lead problem solving and resolution efforts. Provide dedicated and creative recommendations on how to meet goals and handle identified risks and deviations You will ensure that work is conducted in compliance with professional standards and SOPs, and meet quality and timeline metrics You will build and maintain strong pharmaceutical industry sponsor and organizational team relationships for the success of clinical trial management You will partner with other team members to initiate improvements to enhance the efficiency and the quality of the work performed on assigned clinical trials You may participate in proposal development
Qualifications You should have: Minimum 8–12+ years clinical operations experience Minimum 3-5 years’ previous experience as a Global Clinical Trial Manager or Project Manager for a CRO / pharmaceutical company / biotechnology company managing study timelines, deliverables and vendors Minimum 2 years’ Experience in hematological malignancies Phase I-III clinical trials Knowledge of FDA and or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies Prior CRA experience (preferred) Enjoy the fast pace in start-up company Able to respond to issues/problem quickly and resolve them in timely manner. Demonstrated leadership skills Able to work with team members with various background and experiences Bachelor’s Degree (4-year program) or higher It would be helpful if you had: Prior experience mentoring and/or training less senior team members Experience editing and managing the process of clinical trial document creation including protocols and informed consent statements
We would love to talk to you about this fantastic opportunity.
If you are highly qualified you will hear from one of our recruiters. We are actively interviewing so apply today.