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Clinical Development Director
2 months ago
EPM Scientific is a pioneering pharmaceutical company dedicated to the discovery, development, and delivery of innovative treatments for patients with rare and life-threatening diseases. Our mission is to transform the lives of those affected by these challenging conditions through cutting-edge research and patient-centric drug development.
About the RoleWe are seeking an experienced and visionary Clinical Program Lead to join our dynamic team. In this role, you will be responsible for overseeing the strategic planning, execution, and management of clinical development programs from early-stage development through to regulatory submission and post-marketing support.
Key Responsibilities- Clinical Program Strategy and Leadership: Develop and lead the clinical development strategy for assigned programs, ensuring alignment with overall company objectives and therapeutic area goals.
- Program Management and Execution: Oversee the day-to-day management of clinical programs, including study design, protocol development, site selection, patient recruitment, data collection, and analysis.
- Regulatory and Compliance: Serve as the primary point of contact for regulatory agencies, overseeing the preparation and submission of regulatory documents, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), and New Drug Applications (NDAs).
- Data Analysis and Interpretation: Collaborate with biostatistics, data management, and clinical operations teams to ensure the accurate and timely analysis of clinical trial data.
- Cross-Functional Collaboration: Work closely with internal and external stakeholders, including Key Opinion Leaders (KOLs), investigators, and patient advocacy groups, to ensure the success of clinical programs.
- Budget and Resource Management: Manage program budgets, ensuring the efficient allocation of resources and adherence to financial constraints.
- Team Leadership and Development: Provide mentorship and leadership to junior clinical staff, fostering a culture of continuous learning and professional growth.
- Education: A Master's or Doctoral degree (MD, PhD, or PharmD) in a relevant scientific discipline such as Clinical Research, Medicine, or Pharmacology.
- Experience: A minimum of 8 years of experience in clinical development, with at least 3 years in a leadership role within the pharmaceutical or biotech industry.
- Technical Skills: In-depth knowledge of clinical trial design, execution, and regulatory requirements.
- Leadership and Communication Skills: Exceptional leadership abilities, with a demonstrated capacity to lead and inspire cross-functional teams.
- Analytical and Problem-Solving Skills: Strong analytical skills, with the ability to interpret clinical data and make informed decisions.
- Organizational and Project Management Skills: Highly organized, with strong project management skills and the ability to manage multiple complex projects simultaneously.
- Impactful Work: Join a company at the forefront of rare disease research, where your work will directly contribute to improving the lives of patients with unmet medical needs.
- Professional Growth: Opportunities for career advancement and professional development in a fast-growing, innovative company.
- Collaborative Environment: Work alongside passionate and dedicated colleagues in a collaborative and supportive work environment.
- Competitive Compensation: A competitive salary and benefits package, reflective of your experience and contributions.
