Senior Clinical Scientist

vor 1 Monat

Basel, Schweiz VECTURA FERTIN PHARMA Vollzeit

Contract Type: Permanent

Closing date:

Reference: VN1853


Who we are:

Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems.

We are driven by the exciting and unique goal of addressing unmet patient and consumer needs by revitalizing, repurposing, and reimagining existing therapies to better serve people in taking care of their health and wellbeing.


What we will deliver:

We focus on the development of a proprietary pipeline of wellness and healthcare products, with a specific focus on highly differentiated products that address unmet medical and consumer needs.

By leveraging our unique and enabling RD capabilities, we are building a pipeline that includes inhalable medicines, nicotine replacement therapies (NRT), and consumer wellness products.


About the role:

As a Senior Clinical Scientist you will be responsible for working with physicians and clinical operations leads to provide clinical research support to assigned clinical studies and programs.

Key responsibilities will include:
  1. Lead the delivery of the clinical strategy for assigned assets.
  2. Providing 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.
  3. Ensuring that the 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).
  4. Represent clinical science in the clinical trial meetings and collaborate with cross-functional team members including operations, regulatory affairs, safety, medical etc. and external partners.
  5. Lead scientific oversight 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.
Job Requirements:
  1. PharmD, PhD, or Master in Life Sciences with demonstrable experience in RD in Global Drug Development in a pharmaceutical company or in CRO in a similar position.
  2. Demonstrated experience in designing and executing phase II (Proof-of-Concept and Dose Ranging Studies) and/or phase III clinical trials in neuroscience.
  3. Track record of successful trial submissions and responses to HA and EC.
  4. Good understanding of Drug Regulatory Affairs, biostatistics, clinical operations, PK, medical sciences and medical affairs.
  5. Experience in working with and managing CROs.
  6. Strong leadership experience in matrix environments with effective communication with peers and external experts.
Desirable experience:
  1. Chronic/neuropathic pain experience, medical device experience, respiratory experience are a plus.
  2. Prior experience working with phase I and II clinical studies is a plus.
Desirable behaviours:
  1. Very well structured and organized, able to prioritize.
  2. Able to learn proactively, tackle issues, and take and drive accountability.
  3. Experience in identifying, assessing and understanding needs of key decision makers and stakeholders.
  4. Building effective relationships with team and senior leaders in a matrix environment.
  5. Strong analytical and strategic skills.
Why Join Us?

We are bound by our shared passion for making a positive impact on the lives of patients and consumers. Vectura Fertin Pharma is a place where you can help shape the future of healthcare, where we collaborate, support, and inspire each other to achieve the best outcomes.

As a growing business, we can offer a wealth of opportunity to develop your career both locally and in international settings.

We embrace hybrid and flexible working and are centered on delivering a ‘purpose-driven’ experience for all our employees.

Be part of an inclusive, diverse culture, where everyone’s contribution is respected; collaborate with some of the world’s best people and feel like you belong.

Location: Basel, Switzerland

Messeplatz 10
CH-4058
Basel
Switzerland

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