Clinical Scientist

Grifols; Dublin; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

A highly competitive salary package

Group pension scheme

Private medical insurance for the e m

Ongoing career development

Succession planning

Education and professional development

Wellness and social initiatives

Job summary

Grifols is seeking a Clinical Scientist to contribute to scientific strategies for new indications and to evaluate literature for regulatory documents. The role supports MDs with clinical inquiries, ongoing trials, risk evaluation, safety narratives, and advisory boards to ensure smooth regulatory and trial processes.

You will build clinical protocols, review study literature, and collaborate with Medicines Development/Evidence Generation groups to advance program development across indications

Qualifications

• Experience in pharmaceutical/medicine development.
• Strong understanding of GCP and ICH regulations.
• Ability to synthesize literature for study designs and regulatory documents.
• Experience supporting advisory boards and regulatory submissions.

Responsibilities

• Develop scientific strategies for new indications and review literature to support regulatory documents.
• Support MDs with clinical enquiries, ongoing trials, risk evaluation and safety narratives.
• Contribute to study design, protocols, and regulatory dossiers with cross-functional teams.
• Assist in responding to clinical questions from countries and coordinating with global teams.

Skills

Clinical trial experience

Regulatory understanding

Data interpretation

Communication with MDs

Education

Master's degree

PhD

Job description

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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

At Grifols, 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.

Position Summary:

Grifols is seeking 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. They support MDs with clinical enquires, ongoing trials, risk evaluation, safety narratives, and advisory boards ensuring smooth regulatory and trial processes.

What You Will Do:

• Participates and contributes in building/evaluating scientific development strategy for new indications or entities assessing success potential and vetting plans to the business in collaboration with medical directors (MD).
• Contributes to scientific literature evaluations, supports gathering of key opinion leader input, interprets data in support of content for regulatory agency document production (Pediatric Study Plans, Protocols, Briefing booklets, clinical study reports, integrated submission dossiers and other regulatory documents) with other team members.
• Supports with MD responses to clinical questions from countries across the globe for marketed products.
• Supports MDs with Advisory boards, safety narratives, and ongoing trials in aspects of protocol deviations, problem solving to facilitate data cleaning.

Clinical Studies and Study Documents:

• Supports the leading physician in the development of clinical protocols/protocol amendments for new therapeutic indications and with overall program development for business consideration. Work closely with other members of Medicines Development/Evidence Generation group such as with Biometry, Clinical Operations, Pharmacology, Pharmacovigilance, HEOR.
• Synthesizes literature and competitive information for study designs and results for assigned therapeutic area.
• Participates and contributes to specific study documents managed or owned by clinical/regulatory groups, such as Investigator Brochures, Pediatric plan, Briefing books, Clinical Study Reports, clinical section review of BLAs, SAE narrative construction, etc.
• Supports Regulatory department in the preparation of Authority meetings (e.g. pre-IND meetings, preparation of briefing meeting request & package ).
• Support clinical questions from all countries with marketed product and or new submission dossiers. Support strategy to update core dossiers for clinical sections of dossiers on a periodic basis.
• May participate in the scientific review process in potential due diligences when evaluating external opportunities.

Expert Medical Meetings and Publications:

• Participate in the scientific review/input for publications from clinical study data.
• Participate and contributes to internal and external meetings for clinical/non-clinical program(s).
• Participates in facilitating the compliance and contractual agreement to onboard Key Opinion Leaders (KOLs) and external experts, as well as steering advisory boards, and participate in scientific exchange meetings in these forums.

Department Processes:

• Participates in implementing departmental standardizations for new and improved practices and or consistent work practices (e.g. templates, organizational practices).
• Contributes in providing input into SOPs and working practices.
• Produces training materials, share best practices and provides training to the Clinical development team.

What You Will Bring:

• Masters: 2+ years as a Clinical Trial Scientist or 4+ years as a Clinical Program Leader (or equivalent) with at least 2 years of clinical document production and or clinical trial feasibility and strategy or related experience.
• PhD: 1+ years as a Clinical Trial Scientist or 2+ years as a Clinical Program Leader (or equivalent) with at least 2 years of clinical document production and or clinical trial feasibility and strategy or related experience.
• Additional experience may include other pharmaceutical or academic research.
• Significant experience in pharmaceutical or medicines development and excellent understanding of all aspects of scientific and clinical methods used in medicines development.
• Good knowledge of Good Clinical Practices (GCP), federal regulations and international regulations (International Harmonization Committee-ICH regulations).

Our Benefits Include:

• A highly competitive salary package
• Group pension scheme - Contribution rates are (3%/ 5%/ 7%) and company will match
• Private medical insurance for the employee
• Ongoing career development opportunities within a rapidly growing organisation
• Strong focus on succession planning and internal promotion
• Dedicated education and professional development allowance
• Wellness and social initiatives, including activities such as padel and summer events

We understand that self-doubt can hold talented individuals back from applying for opportunities.