Chief Medical Officer

What You'll Do:


* Lead global Medical Affairs and RSA teams with clarity of vision and purpose.



* Develop and maintain departmental global business plans.



* Meet or exceed department sales and revenue objectives.



* Participate in Business Development (BD) capabilities presentations, prepare for and attend client visits and programs.



* Build high performance teams within each of the functions.

Develop, update, and counsel team members on career development and advancement.



* Ensure all projects are completed according to contractual agreements (budget, timelines and deliverables) and CTI SOPs.



* Develop and assess strategies to drive client satisfaction.



* Oversee the development of SOPs.



* Oversee and review processes for deliverables, responsible for quality oversight of all project deliverables.



* Develop and oversee Medical Monitoring Plans.



* Ensure the safety of all patients in clinical trials and ensure clinical trials are conducted according to ethical standards in medicine, providing medical, clinical development and regulatory input.



* Review and manage all serious adverse events (SAE) during the course of the clinical trials, in collaboration with Safety Department.



* Collaborate with global teams throughout the regulatory submission and approval process.



* Provide leadership for scientific writing projects, collaborating with team members to ensure medical accuracy.



* Participate in advisory boards, training programs, and development and review of scientific writing projects.



* Oversee medical review of the protocol, Investigative Drug Brochure (IDB), Case Report Forms (CRFs), Clinical Study Report (CSR), patient narratives and other high-profile documents, such as marketing applications, clinical safety/efficacy summaries and overviews.



* Develop and manage department budgets.

What You'll Bring:


* 15 years of pharmaceutical / Contract Research Organization (CRO), drug development, Regulatory experience, with progressive management responsibilities.


* Scientific, regulatory, clinical trial or drug development experience.


* Thorough knowledge of relevant FDA and other international health authorities' regulations and guidelines, including directly interacting with such authorities, and GCP and ICH guidelines.


* Master's, PhD, or MD

Why CTI?


* We support career progression - 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward


* We value education and training - We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department


* We value our people - We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade


* Our culture is unp...