Director, Clinical Research Cover Letter

In response to your job posting for director, clinical research, I am including this letter and my resume for your review.

In the previous role, I was responsible for support to Research and Translational Science and in the development of preclinical PK-PD knowledge required for early clinical development strategy, as well as utilizing Pharm-Tox data appropriately in the development of early clinical studies.

Please consider my qualifications and experience:

• In-depth understanding of the drug-development process, safety assessment and regulatory requirements
• Direct GLP Experience either as a Study Director or Testing Facility Management
• Experience in overseeing in vivo laboratories
• Understanding of IT/IM systems
• Experience with outsourcing strategies and a basic knowledge of contracting processes
• Board Certification (Diplomate of the American Board of Toxicology) Desirable
• A combination of credentials and personal attributes including medical training, reputation, clinical and industry drug development experience and integrity are necessary for success in this role
• Strong verbal, written and interpersonal skills (communication skills)

I would like to submit my application for the director, clinical research opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for guidance to project teams for identifying targets, drug candidates and research strategies with a translational path that enables learning and decision making in early clinical development.

Please consider my experience and qualifications for this position:

• Regulatory knowledge highly desirable
• Monitoring experience preferred
• Experience in coordinating and managing the efforts of health care personnel who work in the clinical trials arena
• Working knowledge of California Board of Registered Nurses Regulation 2725, and Title 22 in addition to The Joint Commission Standards
• Knowledge and experience in managing clinical trials
• Knowledge of regulatory guidelines and requirements for the conduct of clinical trials and research subjects protection
• Knowledge and experience in the clinical research environment
• Knowledge and experience in health care setting

I would like to submit my application for the director, clinical research opening. Please accept this letter and the attached resume.

Previously, I was responsible for technical guidance and expertise in the area(s) of small molecule process development, pre-formluation developability assessment, formulation development and clinical supplies with a working knowledge of drug development from IND to NDA.

Please consider my experience and qualifications for this position:

• Expertise in pre-award and post-award management of clinical research contracts
• Advanced knowledge in data analysis and modeling
• Advanced knowledge in principles of Lean methodology or other quality improvement methodology with demonstrated success with application of the principles
• RN or similar clinical experience is highly preferred
• The role requires a high performing and energetic individual who demonstrates outstanding scientific knowledge, applicable to nephrology clinical research and the highest and personal ethical standard
• A good understanding of the pharmaceutical clinical development process
• Highest scientific and personal standards and ethics
• Knowledge of applicable U.S. regulations and guidelines

Please consider me for the director, clinical research opportunity. I am including my resume that lists my qualifications and experience.

In the previous role, I was responsible for pKPD input for regulatory submissions such as briefing documents, IND, Clinical Trial Application (CTA) and New Drug Application (NDA);.

Please consider my experience and qualifications for this position:

• Accredited residency in Oncology/Hematology sub-specialty, board certified or eligible
• Experience with clinical trials as Investigator or Sub-Investigator
• Possess strong interpersonal, oral and written communication skills in order to effectively and independently oversee clinical operations and communicate results
• Able to confidently interact with all levels of management including senior management, PI’s and others
• Demonstrated expertise in evaluation and analysis of clinical/scientific data, ideally with successful publications thereof
• Displays sense of urgency, and a willingness to roll up sleeves to get the work done
• Clinical trials experience is highly desirable
• Certification in Healthcare Research Compliance (CHRC) from HCCA preferred

I submit this application to express my sincere interest in the director, clinical research position.

Previously, I was responsible for expert medical/scientific therapeutic area expertise and clinical development expertise into all stages of drug development.

Please consider my experience and qualifications for this position:

• Knowledge of clinical care in a clinical research setting
• CRA , project management and CRM experience, an asset
• Effective communication with external customers
• Certification in clinical research (CIP, SOCRA, ACRP or equivalent)
• Demonstrated sound knowledge of clinical medical device standards, FDA Code of Federal Regulations, GCP/ICH guidelines, regulatory compliance (BIMO) and relevant experience in clinical aspects of submissions to Health Authorities
• Excellent staff supervision, motivation and development skills
• Knowledge of scientific and regulatory requirements applicable to early phase clinical studies
• Excellent clinical data interpretation and verbal and written communication skills