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Director, Clinical Research Scientist

Kaztronix

Wilmington, DE

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JOB DETAILS
SKILLS
Analysis Skills, Biology, Biotech and Pharmaceutical, Brochures, Clinical Practices/Protocols, Clinical Research, Clinical Trial, Communication Skills, Compensation and Benefits, Contract Research Organization (CRO), Cross-Functional, Drug Development, Employee Benefits, FDA (Food and Drug Administration), Human Resources, Investigator INDs, Leadership, Medical and Scientific Writing, Multitasking, Oncology, Presentation/Verbal Skills, Regulatory Submissions, Scientific Publications, Scientific Research, Startup, State Laws and Regulations, Training/Teaching, Willing to Travel, Writing Skills
LOCATION
Wilmington, DE
POSTED
12 days ago
Oncology/Solid tumors/Director, Contractor Clinical Scientist (CS)
General Description of Project:
Agency shall provide a Contractor to perform services as an Oncology/Solid Tumors Director, Clinical Research Scientist (CS) Contractor during the term of this Work Order.
Scope of Services:
Contractor shall perform the following responsibilities under the direction of Company Vice President. This position will be responsible for working with physicians, clinical scientists, and cross-functional teams within Oncology/Solid Tumors Clinical Development to provide clinical research support, with an emphasis on protocol development and study start up activities while serving in the role of CS.
Essential Functions of the Job (Key responsibilities of the oncology CS)
" Development of protocols for clinical studies.
" Preparation of clinical development plans.
" Drafting of clinical scientific documents such as IND, IND amendments, Investigator s Brochures, Annual Reports and other FDA submissions.
" Monitor, perform data review, and summarize safety and efficacy data in ongoing studies.
" Assist with study design for exploratory development.
" Lead the clinical matrix teams for assigned compounds.
" Represent exploratory development on project teams.
" Develop relationships with appropriate consultants.
" Write abstracts and present data at scientific meetings, both internally and externally.
" Serve as liaison to project teams, CROs and others

Qualifications
" Degree in a scientific/life sciences field; Pharm.D. or Ph.D. preferred.
" Minimum of 8 years of experience in oncology research or related field.
" Demonstrated experience leading clinical development programs in oncology (preferably late-stage).
" Experience with global regulatory interactions and submissions (FDA, EMA, or other agencies).
" Strong understanding of oncology clinical endpoints, trial design, and statistical considerations.
" Proven ability to work effectively in a cross-functional matrix environment and influence without direct authority.
" Track record of scientific publications and/or conference presentations.
" Excellent written and oral communication skills.
" Strong analytical and scientific writing skills.
" Ability to manage multiple priorities in a fast-paced environment.
" Minimal travel (H15%) may be required with prior approval.

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.

About the Company

K

Kaztronix

Kaztronix is committed to the clients and employees we serve. Our mission is to provide the best and brightest industry talent, solutions, and services available. We have been working with various industries and clients across the United States for nearly 10 years.

COMPANY SIZE
100 to 499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2002
WEBSITE
http://www.kaztronix.com/