Medical Director

JOB PURPOSE / SUMMARY

Responsible for providing scientific leadership and medical expertise for all medical affairs and clinical research projects within the MEA region including : medical writing activities, advisory boards, client engagement, study design expertise and medical input into clinical trials and RWE studies . This role manages and oversees MEA Medical Writing staff members. This role may also participate in traditional medical monitoring activities on clinical trials.

ESSENTIAL FUNCTIONS

• Provides oversight and mentoring of the Medical Writing team and all associated activities within the MEA region. 
• Provides leadership in the development of study protocols, abstracts, white papers, literature reviews, meta-analyses, manuscripts and clinical study reports to ensure quality, timeliness and completeness of client deliverables. Leads the development of scientific rationale and methodology and ensures medical accuracy of this work.
• Provides senior level leadership in preparation and attendance of expert panels, advisory board meetings and training programs. 
• Provides leadership and strategic engagement by working directly with clients, in collaboration with business development, and providing input and guidance on study designs, data collection needs and budget estimates. 
• Supports business development to provide medical and scientific expertise in attending capabilities meetings, bid defenses, conferences and client meetings.
• Collaborates with cross-functional teams, including clinical operations, medical affairs, safety, data management and biostatistics.
• Manages and evaluates performance and direct activities of medical writing staff, including adherence to Standard Operating Procedures (SOP’s) and career development.
• Collaborates with others in the region and across regions, including business development, to develop partnerships with study sponsors, government entities, KOL’s and academic institutions.
• Works with Quality Assurance and other functional areas to develop and/or revise SOP’s.  Participates in audits, when necessary.
• Acts as Medical Monitor on clinical studies, when needed, based on expertise.  This can include development of medical monitoring plans, participating on study team calls, collaborating with sites to providing training and address questions and reviewing and managing clinical data, also including labs and SAE’s.
• Provide medical guidance to the results of research studies through manuscript, abstract, and poster development and submission in credible scientific publication journals and platforms

What You'll Bring:

• Min of 3 years in the pharmaceutical, biotech, or CRO industry as Medical Director.
• At least 5 years Medical and Scientific writing expertise, including protocols, literature reviews, abstracts, manuscripts and clinical study reports.
• At least 5 years managing direct reports
• At least 3 years of clinical research experience / knowledge of ICH-GCP /clinical trial design
• MBBCH, clinical practice, participation / conduct of clinical trials and research.
• MSC degree / MD degree is preferable in specialized area such as oncology…..etc. .

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.