Director Oncology Cover Letter

I am excited to be applying for the position of director oncology. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for strategic and operational regulatory direction on projects including, but not limited to general CMC regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and Health Authority interactions.

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:

• Launch experience with Medicare Part B product
• Experience in dialysis (post bundled payment)
• Understanding of how to conduct advisory boards is preferred
• Pharmaceutical industry experience preferably in Medical Affairs is highly preferred
• Negotiation skills, particularly with external partners is preferred
• Experience in key opinion leader interaction is preferred
• Experience in building publication plans is preferred
• Understanding of strengths and weaknesses of different types of anonymous patient level data

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

Previously, I was responsible for regulatory expertise on Emerging Markets for multiple projects including one highly complex program, focused on non-clinical and clinical aspects of registration and / or post-marketing compliance and life cycle management.

My experience is an excellent fit for the list of requirements in this job:

• Advanced understanding of Excel (e.g., macros, pivot tables, external data ranges)
• Knowledge of Joint Commission accreditation standards
• OCN/COS Certified, Nursing Certification in applicable field
• Clinical/medical expertise, effective partnership with sales force, and excellent communication and presentation skills
• Effective people management skills working on a national team (across time zones)
• Experience creating and executing Oncology Training programs designed to support sales and inform the medical community
• Experience in prostate, gastrointestinal or similar cancers is preferred
• Directing others – Energize and inspire others to higher levels of effort and performance

I submit this application to express my sincere interest in the director oncology position.

In the previous role, I was responsible for clinical support to the European Clinical Trial Organisation, Regulatory and Business Development functions within MSD Research Laboratories for the Oncology Therapeutic area.

Please consider my qualifications and experience:

• Experience designing and conducting in vitro, in vivo, and ex vivo experiments in the area of immune biology and disease
• Experience in cancer biology, and experience using multiple types of in vivo cancer models to discover and develop novel cancer therapeutics would also be advantageous
• Proficiency with multi-color flow cytometry and mechanistic studies of immune regulation
• Publication record in immunology or immuno-oncology
• Global HEOR Leadership Team, Oncology Senior Management, Global Market Access, Franchise Value & Access, Pricing Colleagues, Brand Teams, Global Medical Functions, including Biostat, Development Teams for the Franchise
• Regional and country HEOR stakeholders/ collaborators for the assigned BU
• Experience in lung, gastrointestinal or similar cancers is preferred
• Experience in Immuno-Oncology is highly preferred

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

Previously, I was responsible for strategic regulatory direction and leadership on the overall regulatory plan, regulatory requirements for clinical studies and marketing approval, development plans, risk assessments, critical issue management in the US and Europe.

My experience is an excellent fit for the list of requirements in this job:

• Effective organizational and interpersonal skills, communication and language skills, and group presentation skills
• Doctorate in scientific discipline, with robust working knowledge in oncology therapeutic area
• Professional demeanor with strong decision making
• Be able to work independently, manage large cross functional teams, and mentor individuals
• Delivers high quality biomarker strategies for target engagement, pharmacodynamic endpoints and patient selection (where appropriate)
• Oncology marketing experience preferred
• Strong experience with corporate performance management (CPM) and other reporting/analysis tools
• Strong broad based finance background with experience in a decision support capacity administering planning / budgeting / forecasting

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

Previously, I was responsible for regulatory leadership and develop regulatory strategies for MSLN-CAR-T and associated companion diagnostic to support clinical trial application up to marketing approvals.;.

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:

• Experience in Hematology is preferred
• Experience providing global oncology biomarker drug development strategy and leadership
• Proven track record in clinical study design, monitoring and execution, and analysis of results from biomarker perspective
• Strong communication skills (oral, written, and presentations) and cross functional team work are essential
• Demonstrated knowledge of designing, implementing and conducting clinical studies, to produce both timely and good quality data
• Proven record of leading teams and obtaining results in a matrix environment
• Preferred - Experience in an ambulatory setting
• Prior engagement with EMA