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. Partici…
Skills: Medical Affairs Leadership, Drug Development, Regulatory Affairs, Clinical Trial Management, Budget Management
What you'll do: Obtain vital signs; perform ECGs and other clinical procedures Work closely with Clinical Research Coordinators to complete source documentation, case report forms and other study specific documents compl…
Skills: ECG Performance, Vital Signs Monitoring, Specimen Processing, Source Documentation, Case Report Forms
Associate Clinical Director, Laboratory Services - level dependent upon experience
Cincinnati, Ohio, United States · On-site
Senior
Under the direction and mentorship of our Clinical Director, Global Laboratory Services, this position is responsible for providing effective clinical leadership for the development and delivery of global laboratory serv…
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Full-time
postgraduate degree
Career Progression, Mentoring Program, Tuition Reimbursement, Flexible Schedules, Cash Bonuses
Posted 56d ago
~40 hrs/week
Responsibilities
Lead global Medical Affairs and RSA teams to drive revenue objectives and ensure the quality and ethical conduct of clinical trials. Oversee the development of medical monitoring plans, regulatory submissions, and high-profile scientific documentation.
Requirements
Requires a Master's, PhD, or MD with at least 15 years of experience in pharmaceutical, CRO, or drug development roles. Must possess deep knowledge of FDA, GCP, and ICH guidelines along with progressive management experience.
Full job description
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 unparalleled – Click here to learn more about “The CTI Way”
We think globally and act locally – We have a global philanthropic program supporting our team’s efforts to improve their local communities (Click here to learn more about our “CTI Cares” program)
Important Note In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.
Please Note
We will never communicate with you via Microsoft Teams or text message
We will never ask for your bank account information at any point during the recruitment process
Related keywords
Medical AffairsCRODrug DevelopmentFDAGCPICH GuidelinesClinical TrialsMedical MonitoringSAERegulatory SubmissionScientific WritingIDBCRFCSRPatient NarrativesBusiness Development
CTI Clinical Trial and Consulting Services is a global, privately held, research service organization, delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine / gene therapy, immunology, transplantation, nephrology, hematology / oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations. CTI also offers a fully integrated multi-specialty clinical research site and complete global laboratory services. Now in its third decade, CTI is one of the 20 largest contract research organizations in the world, with associates in more than 60 countries across six continents. CTI is headquartered in the Greater Cincinnati area, with operations across North America, Europe, Latin America, MEA, and Asia-Pacific. For more information, visit www.ctifacts.com.
Offices: 100 E. RiverCenter Blvd., ., Covington, KY 41011, US · 1775 Lexington Ave, Cincinnati, Ohio 45212, US · 2840 Plaza Pl, Raleigh, North Carolina 27612, US · 101 Bayhill Drive, San Bruno, California 94066, US · Rua Maria Curupaiti 441 - Design Tower, 3º Andar, Sala 3005, São Paulo, SP 02452-000, BR
Information TechnologyConsultingBiotechnologyPharmaceutical
CTI Clinical Trial and Consulting Services is a global, privately held, research service organization, delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine / gene therapy, immunology, transplantation, nephrology, hematology / oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations. CTI also offers a fully integrated multi-specialty clinical research site and complete global laboratory services. Now in its third decade, CTI is one of the 20 largest contract research organizations in the world, with associates in more than 60 countries across six continents. CTI is headquartered in the Greater Cincinnati area, with operations across North America, Europe, Latin America, MEA, and Asia-Pacific. For more information, visit www.ctifacts.com.
Offices: 100 E. RiverCenter Blvd., ., Covington, KY 41011, US · 1775 Lexington Ave, Cincinnati, Ohio 45212, US · 2840 Plaza Pl, Raleigh, North Carolina 27612, US · 101 Bayhill Drive, San Bruno, California 94066, US · Rua Maria Curupaiti 441 - Design Tower, 3º Andar, Sala 3005, São Paulo, SP 02452-000, BR
Information TechnologyConsultingBiotechnologyPharmaceutical