Employment Classification : Regular/Permanent
Job details :
The Executive Director, Clinical Development will be responsible for providing clinical and scientific input into the development strategy for the clinical portfolio. In addition, the Dir., Clinical Development will provide medical oversight for ongoing clinical trials, including study document development (protocols, IBs etc.), overseeing outsourced medical monitoring, participating in internal clinical data reviews and assessments for safety reports.
Job Duties:
1. Develop and support implementation of the clinical development strategy for the entire portfolio. In conjunction with program management, author clinical development plans.
2. Support interactions with health authorities by providing clinical and scientific expertise and input into drafting of various submissions  (INDs, annual reports, NDAs, inquiry responses etc). Attend meetings with health authorities as needed.
3. Provide medical oversight of ongoing clinical trials:
a. Review, analyze and interpret safety information for clinical trials and provide recommendations based on emerging safety data where appropriate.
b. Compile, analyze and present safety data analysis at (internal and/or external) safety review committee meetings.
c. Maintain oversight of outsourced medical monitoring activities for quality and study plan and SOP compliance.
d. Serve as medical resource for internal and external study teams to address medical / protocol related questions.
e. Regularly attend study team meetings.
f. Work with clinical team to ensure data collected are of high quality, including contributing to development of CRFs, edit checks and data review plans and regularly performs medical data review (including coding reviews).
4. May complete medical review including causality assessments for individual case safety reports and other safety/medical related regulatory documents.
5. Lead development of scientific publications, clinical trial design and protocols, investigator brochures and other study and/or asset level documents.
Represent the company at scientific meetings, conferences and interactions with Key Opinion Leaders, Investigators, health authorities.
6. Represent the company at scientific meetings, conferences and interactions with Key Opinion Leaders, Investigators, health authorities.

The Executive Director, Clinical Development will be responsible for providing clinical and scientific input into the development strategy for the clinical portfolio. In addition, the Dir., Clinical Development will provide medical oversight for ongoing clinical trials, including study document development (protocols, IBs etc.), overseeing outsourced medical monitoring, participating in internal clinical data reviews and assessments for safety reports.
Job Duties:
1. Develop and support implementation of the clinical development strategy for the entire portfolio. In conjunction with program management, author clinical development plans.
2. Support interactions with health authorities by providing clinical and scientific expertise and input into drafting of various submissions  (INDs, annual reports, NDAs, inquiry responses etc). Attend meetings with health authorities as needed.
3. Provide medical oversight of ongoing clinical trials:
a. Review, analyze and interpret safety information for clinical trials and provide recommendations based on emerging safety data where appropriate.
b. Compile, analyze and present safety data analysis at (internal and/or external) safety review committee meetings.
c. Maintain oversight of outsourced medical monitoring activities for quality and study plan and SOP compliance.
d. Serve as medical resource for internal and external study teams to address medical / protocol related questions.
e. Regularly attend study team meetings.
f. Work with clinical team to ensure data collected are of high quality, including contributing to development of CRFs, edit checks and data review plans and regularly performs medical data review (including coding reviews).
4. May complete medical review including causality assessments for individual case safety reports and other safety/medical related regulatory documents.
5. Lead development of scientific publications, clinical trial design and protocols, investigator brochures and other study and/or asset level documents.
Represent the company at scientific meetings, conferences and interactions with Key Opinion Leaders, Investigators, health authorities.
6. Represent the company at scientific meetings, conferences and interactions with Key Opinion Leaders, Investigators, health authorities.
Adress : 700 Klein Road, Plano TX75074