Job Details: Senior Clinical Development Scientist
Location: Basel + hybrid working
About Aspeya:
At Aspeya we strive to make a positive difference to the lives of patients and consumers through science, insight, and innovation. We are on a journey to empower healthier lifestyles and target specific unmet needs. We do this by being innovative, optimizing formulas, and applying rigorous scientific standards. We trust a bold and confident approach, without compromising integrity. Join us and be part of a dynamic, future-thinking environment where your contributions can make a positive difference to people’s lives.
About your role:
We are looking for an experienced Clinical Development Scientist to join our team in Basel in a senior position. This post will immediately contribute to one of our lead programs in Inhaled Therapeutics, targeting a need for patients living with acute migraine, with further clinical trials moving forward throughout 2025 in Phase I and Phase II.
The (Senior) Clinical Scientist will work side-by-side with our expert physicians and clinical operations leads to provide clinical research support and expert scientific input to assigned clinical studies and programs.
As a (Senior) Clinical Development Scientist you will:
1. Provide scientific input into clinical trial/program level documents including: clinical trial protocols, amendments, ICFs, IB, safety updates, submission documents and briefing books, clinical overviews and summaries, CSRs, SAP, eCRF, CDPs, clinical evaluation reports.
2. Ensure study documentation is developed following ICH-GCP, with respect to subject assessment of eligibility, enrolment, clinical safety (adverse events, serious adverse events), data consistency, as well as the quality management system (QMS).
3. Represent clinical science in the clinical trial meetings.
4. Collaborate with cross-functional team members including operations, regulatory affairs, biostatistics, safety, medical, etc., and external partners.
5. Liaise with vendors and lead scientific oversights of CRO activities.
6. Lead clinical data review.
7. Participate and present at Investigator Meetings.
8. Train sites and CRO on clinical trial protocol requirements, assessments, study specifics.
9. Participate and present at Key Opinion Leaders AdBoards.
10. Support Clinical Trial Operation to execute clinical trials.
11. Co-lead with trial operations CRO and external vendors recruitment activities.
12. Prepare scientific abstracts, posters, and presentations for conferences and external events.
13. Lead the delivery of the clinical strategy for assigned assets.
14. Mentor less experienced staff members.
You will be joining Aspeya at an incredibly exciting time with multiple opportunities for you to lead on additional programs in the future while developing your leadership skills.
Job requirements:
1. PharmD, PhD, or Master in Life Sciences with at least 5 years of experience in R&D in Global Drug Development in a pharmaceutical company or in CRO in a similar position.
2. Demonstrated experience in designing and executing phase I (Proof-of-Concept and Dose Ranging Studies) and/or phase II clinical trials.
3. Migraine, medical device or respiratory experience would be a huge plus.
4. Prior experience working with phase I and II clinical studies is essential.
5. Track records of successful trial submissions and responses to HA and EC.
6. Good understanding of Drug Regulatory Affairs, biostatistics, clinical operations, PK, medical sciences and medical affairs.
7. Experience in working with CROs.
8. Strong leadership experience in matrix environments with effective communication with peers, external experts.
9. Proactive with a track record of high-performance standards.
10. Very well structured and organized, able to prioritize.
11. Driving accountability across the teams.
12. High change agility, thriving in an open and dynamic environment. Able to learn proactively, tackle issues, and take accountability.
13. Track record of thinking out of the box.
14. Experience in identifying, assessing, and understanding needs of key decision-makers and stakeholders.
15. Building effective relationships with team and senior leaders in matrix environment.
16. Strong analytical and strategic skills.
17. Candidates must be local to Basel or able to be on site in Basel at least 2 times a week.
18. Ability to travel <10%.
We embrace hybrid and flexible working and are centered on delivering a ‘purpose-driven’ experience for all our employees!
Join our journey! At Aspeya, your ideas matter. Apply now and contribute to meaningful projects that improve lives worldwide.
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