Senior Medical Director Cover Letter

I would like to submit my application for the senior medical director opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.

Please consider my qualifications and experience:

• Able to maintain familiarity with progress in the field
• MD or internationally recognized equivalent
• MD (strongly preferred), Ph.D., or PharmD
• Demonstrated excellence & credibility with internal and external customers
• Creation of solid plans and reports for which performance and progress can be measured and evaluated • Knowledge and application of business planning & leadership principles, such as goal setting, action plans, monitoring tools, directive and supportive techniques to develop and implement action plans
• Requires MD, PhD or PharmD with clinical and public health experience in a medically related field and in resource limited settings
• Working knowledge of relevant FDA regulations and guidelines for conducting clinical trials
• Published and respected in the immunology/immuno-oncology community

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

In the previous role, I was responsible for guidance to managers before, throughout, and following clinical trials to ensure compliance for proper study conduct throughout clinical trials.

Please consider my qualifications and experience:

• Interface with cross-functional colleagues across the organization
• Cancer Immunotherapy expertise highly preferred
• Design early clinical development strategies, act as the leader of Clinical Development Teams (CDT)
• Act as a Global Project Team (GPT) clinical representative and assume medical responsibility for an entire project/program
• May act as manager of Medical Directors as assigned
• Provide medical and scientific expertise/input to business development activities, to discovery and non-clinical development, to stratified medicine, medical communications, quality assurance, clinical operations, biostatistics, regulatory affairs and drug safety
• Medical Doctor (MD) specialized in the therapeutic area Oncology
• Global recognition as expert in clinical drug development with sound knowledge in early development, including pharmacogenomics and pharmacokinetics

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

In my previous role, I was responsible for clinical expertise and technical excellence for asset development, clinical strategy, ensuring compliance with internal and external standards (regulatory authority requirements, stakeholder requirements and quality standards).

Please consider my qualifications and experience:

• Successful leadership and mentorship of individuals and teams in industry or academia
• Excellent understanding of the molecular pathways underlying cancer with demonstrated success in translating to development of drugs
• Understanding of drug development process from target identification through marketing approval
• Medimmune Oncology translation medicine internally and externally to academic community and regulatory bodies
• Knowledge and practical mastery of clinical quality improvement methods and tools
• Get input from key affiliates to develop Global Medical Plan and communicates final Global Medical Plan to all Affiliates
• Strong leadership skills acquired in a multicultural environment
• Good communication and collaborative skills with experience at working with cross-functional and external groups, including researchers, clinicians and other stakeholders

Please consider me for the senior medical director opportunity. I am including my resume that lists my qualifications and experience.

Previously, I was responsible for medical input to the assessment of emerging safety information, from clinical trials in partnership with the responsible clinical scientist and clinical trials physician.

Please consider my qualifications and experience:

• Proven track record of delivery of experimental or novel studies
• Confidence at presenting at internal and external strategy meetings
• Full working knowledge of GCP guidelines
• Sound knowledge in FDA and international regulatory requirements, ICH/GCP, and clinical product development
• Evidence of successful project management and team leadership experience and cross-functional clinical project management skills
• Industry experience in the Hematology / Oncology area, with a network of KOL's
• Exceptional scientific written and verbal communication capabilities and skilled at diplomacy and capable of effectively combining science and relationship building
• Proficient at building working relations throughout the organization and with business partners to achieve business goals

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

In the previous role, I was responsible for support as needed to Clinical Development and Clinical Operations to ensure successful execution of our clinical trials program.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Strong team player, able to work in a matrix organization with experience in international and cross-functional teams
• Working experience with relevant R&D interface partners, Pharmacology, DMPK, Toxicology & Safety Pharmacology, Clinical Development & Operations and Regulatory Affairs
• Develops clinical strategy, identifying areas of clinical focus, developing initiatives to improve appropriate inpatient utilization and other functions and representing same to senior management
• Track record of successes in a fast-paced scientifically rigorous environment requiring a deep understanding in the field of Urology
• Demonstrated customer focus and customer satisfaction demonstrated continuous improvement of processes/assets
• Equivalent academic experience can be substituted
• Respected in Training profession with a track record of proven pragmatic solutions and sustainable business results
• Recognized as a strong leader with a proven track record of effectively managing and developing people