Clinical Scientist
hace 3 semanas
Grifols is a global healthcare company that has been improving the health and well-being of people worldwide since 1909. We are seeking a Clinical Scientist to join our Clinical Development team.
This role will contribute to developing scientific strategies for new indications, evaluating scientific literature, and interpreting data for regulatory documents. The successful candidate will support MDs with clinical inquiries, ongoing trials, risk evaluation, safety narratives, and Advisory Boards, ensuring smooth regulatory and trial processes.
Key Responsibilities:
- 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.
Requirements:
- Bachelor's Degree in Health Sciences or related field.
- 2+ years of experience as a Clinical Trial Scientist or 5+ years as a Clinical Program Leader (or equivalent).
- Significant experience in clinical document production and/or clinical trial feasibility and strategy, or related areas.
- Fluent in both Spanish and English (C1.1 level or above).
- Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions.
- Interact effectively with key stakeholders across departments, divisions, and the company.
- Excellent team player and capable of working in cross-functional teams.
- Proactive approach, strategic thinking, and result-oriented.
- Available to travel occasionally.
What We Offer:
Grifols is committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment. We offer a brilliant opportunity for you to join our company and contribute to improving the health and well-being of people worldwide.
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