Global Clinical Development Lead Cover Letter

Please consider me for the global clinical development lead opportunity. I am including my resume that lists my qualifications and experience.

In my previous role, I was responsible for expert Medical advice / leadership to the project teams for the development of Phase I- IV clinical programs.

Please consider my qualifications and experience:

• Work closely with experts within CP&P to have pharmacokinetic and pharmacometric aspects of assigned projects fully covered and integrated into clinical plans
• Determine the strategy for the selection and use of relevant external advisors and vendors as needed for the execution of an early clinical study
• Lead the design and protocol development for an early clinical study
• Lead clinical contributions to regulatory documents, including Investigator Brochures and dossiers for Agency interactions
• Lead the high quality review and interpretation of study outcomes for assigned studies and oversees the presentation thereof in clinical study reports, related study documentation, and to varied team and governance audiences
• Maintains a strong understanding and awareness on new and emerging medical developments
• MD or M.D./Ph.D, Board Certified
• Experience working in Neuroscience or Genetic Disorders is highly preferred with clinical trial experience in Rare Genetic Metabolic Diseases

I am excited to be applying for the position of global clinical development lead. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for clinical leadership for autoimmune drug discovery and development, serve as top representative for clinical development / medical strategy areas both internal and external facing (e.g., CRO, KOL and clinical site staff).

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:

• Excellent knowledge of the competitive environment for drugs in the Ophthalmic marketplace and in research and development pipelines
• Experience with the Medical Device Regulation (MDR) and clinical evaluations
• Experience in designing and conducting clinical trials
• Experience with product development and design control in device and combination products
• Work closely with clinical development devices team comprised of clinicians and clinical program leaders
• Solid knowledge of device FDA, ICH, GCP, MDR guidelines
• In depth knowledge and experience evaluating, and leading teams to evaluate, clinical literature, clinical summaries, clinical protocols, and materials that include clinical data and safety data in medical device and combination products
• Clinical experience in General Pediatrics and/or Pediatric Nutrition

Please consider me for the global clinical development lead opportunity. I am including my resume that lists my qualifications and experience.

In my previous role, I was responsible for clinical leadership for vaccine drug discovery and development, serve as top representative for clinical development / medical strategy areas both internal and external facing (e.g., CRO, KOL and clinical site staff).

Please consider my experience and qualifications for this position:

• Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes
• Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 1,2 and/or 3 clinical trials in inflammation/immunology
• Prior regulatory experience with familiarity with FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
• Strong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution path
• Good academic credentials and publication records
• Expert in clinical drug development through all phases (phase I to IV)
• Experiences in interaction with Health Authorities in Europe, US and possibly Japan and/or China
• In-depth knowledge of ICH-GCP and other applicable regulatory guidelines/practices

I am excited to be applying for the position of global clinical development lead. Please accept this letter and the attached resume as my interest in this position.

In my previous role, I was responsible for expert device development advice to assist the project teams for the development of clinical programs.

Please consider my experience and qualifications for this position:

• Experience in planning and managing departmental budgets
• Willingness to travel frequently (domestic and intercontinental)
• Strong understanding of the Metabolism and Nutrition market (pharma, biotech, diagnostics, medtech, nutrition)
• Established strong network in the field of Metabolism, KOL and institutional
• A proven success record in Phase I-IV clinical research studies and trial design the successful submission of IND’s and marketing approval-directed filings (BLA’s, NDA’s, and MAA’s)
• Knowledge of relevant FDA regulations and guidelines those of the EU and other health authorities
• Experience with, or strong knowledge of Ophthalmic drug development
• Experience in translational medicine, clinical pharmacology and early stage development is desirable

I am excited to be applying for the position of global clinical development lead. Please accept this letter and the attached resume as my interest in this position.

In my previous role, I was responsible for strategic clinical programs input to Global Development Team (GDT) and Product Strategy Team (PST) as required.

Please consider my experience and qualifications for this position:

• Experience in Pediatric Gastroenterology would be a strong asset
• In-depth experience in clinical trial design and management
• Expertise in medical writing and scientific communication
• Good interpersonal, communication, negotiation, and prioritization skills
• Have primary responsibility for delivery of a program of studies (or indication-specific group of studies) and be key point of contact for portfolio leaders in the Oncology Therapeutic Area
• Experience in developing and writing study protocols, study procedure manuals, informed consent forms and clinical study reports
• In depth knowledge of study management, global regulatory guidelines and ICH/GCP
• Experience working with investigators, external experts, Contract Research Organizations and vendors