Senior Clinical Research Scientist

WE ARE HIRING

SENIOR CLINICAL RESEARCH SCIENTIST

Neuraxpharm is looking for people who want to make a difference and improve patients' lives within the CNS area. We want individuals who will go the extra mile and make great things happen.

Being part of this team does not mean you are just working for a company, but for a cause

Neuraxpharm is looking for a Senior Clinical Research Scientist based in Barcelona

(hybrid role)

Your mission:

To correctly plan, design and monitor the different tasks related to the execution and oversight of clinical trials and bioequivalence studies, following current national and international regulations, as well as the company's internal SOPs,with the final purpose to obtain the final clinical reports and the corresponding dossier modules that granted the registration of a drug product.

Your major accountabilities:

• Design, contracting, oversight and monitoring of clinical and pre-clinical trials.
• Identify, select and hire contract research organizations, vendors and/or public sites to perform clinical studies.
• Request the pertinent authorizations to the applicable Health Authorities to perform clinical studies, as well as the corresponding certificates and all the required documentation.
• Inform and interact with the Pharmacological Development Unit to obtain the medication from the clinical trials of the company's affiliates and their subsequent return, when applicable.
• Evaluate the consistency of the results of clinical trials. File all the generated documentation in association with a clinical trial performance.
• To update and/or prepare new SOPs (PNTs) of the Department.
• Control the evolution and follow-up of the clinical trial and alert about possible incidents.
• Act as valid interlocutor with the Clinical Trials Quality Assurance Unit and respond to audit reports.
• Preparation of Module 5 of the drug registration dossier.
• Provide technical support to the Registration Department in its relationship with the Health Authorities during the evaluation of registration files.

We would like you to have:

• Minimum experience of 2 years in management, coordination and conduct of clinical trials OR 4-5 years developing tasks as a senior CRA (Clinical Research Associate) with complete autonomy.
• Phases 1 experience including Bioequivalence, PK, DDI studies
• Familiar with Competent Authorities interactions (EMA,FDA)
• Experience in the field of generic specialties and clinical bioequivalence studies is extremely valued.
• Clinical Operation Overview experience in therapeutic advanced clinical trials will also be valued.
• Knowledge of bioequivalence studies procedures and the applicable regulation in different territories
• Bachelor's degree in Health Sciences, preferably Pharmacy, Biology or Biochemistry.
• High English

ABOUT US

Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 40 years.

Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline and acquisitions.

The company has c. 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, one in the Middle East and globally via partners in more than 50 countries. Neuraxpharm is backed by funds advised by Permira.

Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratories Lesvi) in Spain.

Be part of the team where you can count on us to deliver:

• Individual Professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
• Attractive remuneration according to the experience and skills provided.
• An inspiring leadership team that drives performance.
• An inclusive culture promoting diversity across the teams that will inspire you every day with a passionate, a dynamic, a result focused and an expert&excellent team

Interested in knowing more?

Have a look at what Neuraxpharm culture represents and what makes us such a great place to work:

If you want to join us, this is your opportunity

WE COUNT ON YOU

At Neuraxpharm, diversity, equity and inclusion is foundational in the way we operate. We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.