Medical Development Lead
Vor 4 Tagen
About the Role:
">As a Senior Clinical Development Scientist, you will contribute to our lead programs in Inhaled Therapeutics. This role involves providing clinical research support and expert scientific input to assigned clinical studies and programs.
">Main Responsibilities:
">- Develop clinical trial/program level documents including clinical trial protocols, amendments, informed consent forms, investigator brochures, safety updates, submission documents, and briefing books.
- Evaluate study documentation for adherence to ICH-GCP guidelines, focusing on subject eligibility, enrolment, clinical safety, data consistency, and quality management system.
- Represent clinical science in clinical trial meetings.
- Collaborate with cross-functional team members, including operations, regulatory affairs, biostatistics, safety, medical, etc., and external partners.
- Liaise with vendors and oversee CRO activities.
- Lead clinical data review.
- Present at Investigator Meetings.
- Train sites and CRO on clinical trial protocol requirements, assessments, and study specifics.
- Present at Key Opinion Leaders AdBoards.
- Support Clinical Trial Operation to execute clinical trials.
- Co-lead recruitment activities with trial operations CRO and external vendors.
- Prepare scientific abstracts, posters, and presentations for conferences and external events.
- Deliver the clinical strategy for assigned assets.
- Mentor less experienced staff members.
Requirements:
">To be successful in this role, you will require a PharmD, PhD, or Master's degree in Life Sciences with at least 5 years of experience in R&D in Global Drug Development in a pharmaceutical company or a similar position in a CRO.
">You must have demonstrated experience in designing and executing phase I (Proof-of-Concept and Dose Ranging Studies) and/or phase II clinical trials. Migraine, medical device, or respiratory experience would be beneficial.
">A strong understanding of drug regulatory affairs, biostatistics, clinical operations, pharmacokinetics, medical sciences, and medical affairs is essential. Experience working with CROs and leadership skills are also required.
">This role requires a proactive individual with high-performance standards, excellent communication skills, and a track record of thinking outside the box.
">We welcome applications from candidates who are local to Basel or able to work on-site at least 2 times a week.
">About Us:
">We strive to make a positive difference in patients' lives through science, insight, and innovation. We empower healthier lifestyles and target specific unmet needs by being innovative, optimizing formulas, and applying rigorous scientific standards.
">We value a bold and confident approach while maintaining integrity. Our dynamic, future-thinking environment offers opportunities for growth and development.
">Benefits:
">We offer a hybrid and flexible working arrangement centered on delivering a 'purpose-driven' experience for all employees.
">We welcome applications from motivated individuals who share our values and vision.
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