Join a global healthcare team that improves the future of healthcare and enhances the lives of millions worldwide. Since 1909, Grifols has been working to advance health and well-being globally.
We value diversity as an essential component of our business, teams, and culture, committed to equal employment opportunities fostering an inclusive environment.
Instituto Grifols S.A. seeks a Clinical Scientist for its Clinical Development team.
About this role
This role contributes to developing scientific strategies for new indications, evaluating scientific literature, and interpreting data for regulatory documents. It supports medical doctors with clinical inquiries, ongoing trials, risk evaluation, safety narratives, and Advisory Boards, ensuring smooth regulatory and trial processes.
Responsibilities:
* Participate in designing and developing study protocols/protocol amendments, supporting lead physicians in creating overall clinical programs for new therapeutic indications.
* Collaborate with Biostatistics, Clinical Operations, Pharmacology, and Pharmacovigilance teams to oversee ongoing programs with several clinical studies and address various indications in development for business considerations.
* Synthesize literature and competitive intelligence to inform study designs and results within the assigned therapeutic area.
* Contribute to (and/or review) specific study documents managed or owned by clinical/regulatory groups, such as Investigator Brochures, Pediatric Plans, Briefing Books, Clinical Study Reports, clinical section reviews of BLAs, SAE narrative construction, etc.
* Support the Regulatory department in preparing for Health Authority meetings (e.g., pre-IND meetings, briefing meeting requests & packages).
* Support Clinical Operations throughout trial execution, providing an additional layer of quality and expertise to clinical programs through participant data reviews, protocol deviation assessments, and risk evaluations to aid mitigation efforts.
* Address clinical inquiries from all countries regarding marketed products or new submission dossiers. Help develop strategies to periodically update the clinical sections of core dossiers.
* Participate in the scientific review process during potential due diligence assessments of external opportunities, presenting and defending conclusions before appropriate committees.
* Participates in facilitating compliance and contractual agreements to onboard Key Opinion Leaders (KOLs) and external experts, as well as steering advisory boards, and participates in scientific exchange meetings.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* You have a Bachelor's Degree in Health Sciences or related field.
* You have 2+ years of experience as a Clinical Trial Scientist or 5+ years as a Clinical Program Leader (or equivalent).
* You possess significant experience in clinical document production and/or clinical trial feasibility and strategy, or related areas.
* You are fluent in both Spanish and English (C1.1 level or above).
* You have strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions. You interact effectively with key stakeholders across departments, divisions, and the company.
* You are an excellent team player and capable of working in cross-functional teams.
* You demonstrate a proactive approach, strategic thinking, and are result-oriented.
* You are available to travel occasionally.
About us
We are fully aware that our employees are one of our major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
We offer a hybrid model with flexibility to work from home part-time. Our schedule is Monday to Thursday, 7am-6pm, and Friday, 8am-3pm. This is a permanent position based in Sant Cugat del Vallés.