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Clinical Development Director

vor 2 Monaten


Basel, Basel-Stadt, Schweiz Batterman Consulting Basel AG Vollzeit
About the Role

Batterman Consulting Basel AG is seeking a highly skilled Clinical Development Director to lead our clinical development strategy for our CRM program. As a key member of our team, you will be responsible for overseeing the clinical development process, ensuring compliance with regulatory requirements, and driving the development and execution of clinical protocols.

Key Responsibilities
  • Lead Clinical Development Strategy: Develop and implement a comprehensive clinical development strategy for our CRM program, ensuring alignment with business objectives and regulatory requirements.
  • Study Monitoring and Collaboration: Monitor clinical trials, collaborate with study centers, and engage with Key Opinion Leaders to ensure successful outcomes.
  • Clinical Protocol Development: Drive the development and execution of clinical protocols, monitoring progress and making necessary adjustments to ensure successful outcomes.
  • Data Analysis and Interpretation: Analyze and interpret clinical trial data, providing insights and recommendations to support decision-making processes.
  • CRO Management: Select, monitor, and coordinate CROs during clinical trials, creating IBs, patient information, and designing study protocols.
  • Regulatory Compliance: Ensure compliance with ICH/GCP guidelines and regulatory requirements.
  • Medical Expertise: Provide medical expertise and oversight throughout all stages of clinical development.
  • Regulatory Agency Interface: Interface with regulatory agencies and health authorities to support product development activities from clinical development to pre-market launch.
Requirements
  • Advanced Degree: Advanced degree in life sciences or healthcare (or clinically relevant degree) is required. PharmD/PhD or MD is strongly preferred.
  • Experience: At least 3 to 5 years of experience in clinical research management with a track record in clinical trial management and CRO management.
  • Knowledge: Working knowledge in the field of rare diseases is desired, with proven ability to interpret, discuss, and present efficacy and safety data relating to clinical trials or program level.
  • Skills: Strong analytical and problem-solving skills, with the ability to determine appropriate actions based on data analysis. Excellent communication and presentation skills, with the ability to effectively convey complex scientific concepts to diverse audiences.
  • Collaboration: Strong collaboration skills and the ability to work effectively with diverse teams from different departments.
  • Project Management: Excellent project management skills, and familiar with digital project management tools.
  • Passion and Commitment: A passion for making a difference in the lives of patients and a commitment to upholding the highest ethical standards.
What We Offer
  • Competitive Salary Package: A highly competitive salary package that reflects your skills and experience.
  • Dynamic Environment: A dynamic and fast-paced environment that offers opportunities for growth and development.
  • Collaborative Team: A collaborative and supportive team that is passionate about making a difference in the lives of patients.