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.
Summary:
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, Diversity Plans, 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. Evaluates risks for ongoing programs. Supports work efficiencies with new tools, templates, working practices within Clinical Development.
Reports to Manager, Clinical Development Scientist.
Primary Responsibilities:
- Participates in the construct of study design and supports the leading physician in the development of clinical protocols for new therapeutic indications and supports leading physician 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, and HEOR.
- Synthesizes literature and competitive information for study designs and results for assigned therapeutic area.
- Contributes to the identification, formulation and implementation of protocol amendments and review of Clinical Study Reports in collaboration with leading physician.
- 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. May lead and contributes (and or reviews) to update core dossiers for clinical sections of dossiers on a periodic basis.
- 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.
- May lead and participate in the scientific review process in potential due diligences when evaluating external opportunities. Presents and defends the conclusions before appropriate committees.
- Participates in process for defining and implementation of publication strategy and provide review/input for publications from clinical study data.
- Participates in congress, symposia, and in scientific, clinical, and medical meetings.
- Leads and 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 in these forums.
- Leads and plans assessments to implement departmental standardizations for new and improved practices and or consistent work practices (e.g. templates, organizational practices).
- Leads, contributes, and reviews in providing input into SOPs and working practices.
- Leads, contributes, and reviews training materials, share best practices and plan/provide training to the Medical director and clinical scientist teams.
Knowledge, Skills, & Abilities:
Advanced knowledge of Good Clinical Practices (GCP), federal regulations and international regulations (International Harmonization Committee-ICH regulations). Expert knowledge and adherence to company SOPs. Expert knowledge of the clinical trial development process, including key interface areas with investigators, preclinical, and clinical teams. Familiar with general clinical trial designs (superiority, non-inferiority, cross-over, enrichment design). Expert knowledge and understanding of cultural and regional differences. Advanced verbal, written, and interpersonal skills necessary to interpret clinical data, communicate findings, and make critical decisions while focusing on multiple priorities. Advanced leadership, issue resolution and project management skills. Expert ability to ensure timely initiation and wrap up of clinical investigations while hitting key milestone elements. Expert ability to maintain, translate and utilize high-level basic science, product, field, technical, medical, and clinical knowledge and information. Expert ability to synthesize and interpret basic and preclinical data that can be communicated to multiple internal and external project teams for determining appropriate strategic clinical development decisions.
Requirements:
- Education: Masters, Pharm D (or equivalent), RN, or PhD.
- Masters/Pharm D/ RN: 4+ 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: 2+ 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.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
Occupational Demands:
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.
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