What You'll Do: Clinical Development & Medical Oversight- Provide executive medical oversight across global clinical trials (Phases I-IV).
- Oversee medical monitoring activities including development and review of Medical Monitoring Plans.
- Ensure appropriate review and management of safety data, including Serious Adverse Events (SAEs), and other clinical parameters included in medical data review processes.
- Partner with Pharmacovigilance, Regulatory, and Quality Assurance teams to ensure compliance with global regulations.
- Serve as medical expert interacting with investigators, sponsors, and regulatory authorities.
- Support study design, protocol development, and feasibility assessments.
Business Development & Revenue Generation- Lead and contribute to RFP responses, including strategy, content, and medical positioning.
- Participate in bid defense meetings, client presentations, and capabilities discussions.
- Partner with Commercial/Sales teams to identify growth opportunities and expand client relationships.
- Provide strategic medical input to win new business and increase revenue.
- Represent the organization at industry events, conferences, and client meetings.
Consulting & Scientific Leadership- Provide medical leadership for consulting engagements and drug development programs.
- Oversee development of clinical documents including protocols, CSRs, regulatory submissions, and publications.
- Serve as subject matter expert for advisory boards and client engagements.
- Ensure scientific integrity across all deliverables.
Operational & Strategic Management- Develop and execute Medical Affairs strategy aligned with company growth objectives.
- Oversee departmental budgeting, forecasting, and resource allocation.
- Ensure development and maintenance of SOPs and implementation of best practices, creating an environment of continuous improvement.
- Drive process improvements to enhance quality, efficiency, and client satisfaction.
- Oversee administrative policies and processes associated with managing the Medical Affairs function, ensuring team members meet foundational expectations of their role.
People Leadership & Talent Development - Attract, develop and retain team members.
- Coach and mentor Medical Directors, and Medical Affairs staff, and others as needed.
- Drive performance management, succession planning, and team capability building.
- Provide training and ongoing education for internal teams.
What You'll Bring:- 10 years of progressive experience in the CRO, pharmaceutical or biotech industry.
- Significant clinical research experience including medical monitoring.
- Deep 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.
- Demonstrated involvement in business development, RFPS, and bid defenses.
- Medical Doctor (MD) degree.
Preferred experience:
- Prior leadership experience in a CRO environment.
- Experience across multiple therapeutic areas.
- Strong network within pharmaceutical and biotech sponsors.
- Board Certification.
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 directly via Microsoft Teams Messaging or by text message
- We will never ask for your bank account information at any point during the recruitment process
