Clinical Scientist
Grifols Shared Services North America, Inc
¿Te gustaría unirte a un equipo internacional que trabaja para mejorar el futuro del sector de la salud? ¿Quieres contribuir a mejorar la vida de millones de personas? Grifols es una compañía global del sector de la salud que desde 1909 mejora la salud y el bienestar de las personas en todo el mundo. Somos líderes en medicamentos hemoderivados y medicina transfusional y desarrollamos, producimos y comercializamos medicamentos, soluciones y servicios innovadores en más de 110 países y regiones.
**We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.**
Instituto Grifols S.A. is seeking for a _Clinical Scientist_ for our Clinical Development team.
This role’s mission is to contribute on developing scientific strategies for new indications, evaluates scientific literature, and interprets data for regulatory documents. It supports MDs with clinical inquiries, ongoing trials, risk evaluation, safety narratives, and Advisory Boards, ensuring smooth regulatory and trial processes.
**What your responsibilities will be**
+ Participate in the design and development of study protocols/protocol amendments, supporting the lead physician 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 to 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, and 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 the compliance and contractual agreement to onboard Key Opinion Leaders (KOLs) and external experts, as well as steering advisory boards, and participates in scientific exchange meetings.
**Who you are**
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.
**What we offer**
It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
Information about Grifols is available at www.grifols.com. If you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply!
We look forward to receiving your application!
Grifols is an equal opportunity employer.
**Flexibility for U Program:** Hybrid Model
**Flexible schedule:** Monday-Thursday 7-10 to 16-19h and Friday 8-15h.
**Professional Group 6**
**Contract of Employment:** Permanent position
**Location:** Sant Cugat del Vallés
www.grifols.com
**Ubicación:** **SPAIN : España : Sant Cugat del Valles** **:** **SC3**
Conoce más sobre Grifols (http://www.grifols.com/es/web/international/home)
**Req ID:** 517784
**Type:** Indefinido tiempo completo
**Job Category:**
Confirm your E-mail: Send Email
All Jobs from Grifols Shared Services North America, Inc