Medical Director

GRIFOLS, S.A.

17d•$170,000 - $240,000•Remote

About The Position

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. The Medical Director will be responsible for clinical strategy relating to upcoming clinical trials, including indication selection, design of trials, and ongoing medical monitoring of safety signals in trials. This is a remote role and candidate can be located anywhere within the US.

Requirements

Medical Degree
Typically requires 8 years of clinical research experience with at least 5 years of clinical document production and/or clinical trial feasibility and strategy or related experience. Additional experience may include other pharmaceutical or academic research in the field.
Hands-on experience with clinical trial design, trial conduct and oversight, including medical monitoring for trials in a broad spectrum of indications including medical immunology, hematology, and oncology.
Knowledgeable in GCP guidelines in US and Europe
Team player with good oral presentation and written skills
Collaborative and flexible in personal interactions
Ability to work proactively and effectively, with exceptional problem-solving skills
Up to 25% travel

Responsibilities

Design of trials, including study population and eligibility criteria, treatment duration, clinical endpoints, biomarkers, and safety mitigation strategy
Serve as the Program Physician for associated clinical trials, addressing patient eligibility and treatment questions in collaboration with the contract research organization (CRO) medical monitor, or directly with study investigators
Work closely with preclinical scientists to understand how the biological effects observed in animals can be translated to humans, and use this information to choose the best clinical endpoints and biomarkers for clinical trials
Be familiar with the nonclinical safety data (toxicology) and use this information to develop safety mitigation strategies in clinical trial design
Serve as a key part of the cross-functional project team, supporting the overall strategy, budget, and timeline of the project
Review safety data for individual subjects and trend review for safety signals from ongoing trials
Interpret, summarize, and present data from clinical trials to the company and externally
Provide strategic input for clinical development plans and regulatory strategy
Provide input/review of clinical documents, e.g. protocols, investigator’s brochures, case report forms
Participate in site/investigator identification and evaluation for clinical trials; conduct site engagement calls and visits
Lead preparation of clinical sections of relevant regulatory filings (IND, study reports, NDA, etc.) in cooperation with colleagues in Regulatory Affairs and other functions
Serve as program medical expert for internal and external collaborators, investigators, consultants, and contract resources
Provide and enhance knowledge in the associated therapeutic area to support global clinical development plans
Represent the company at scientific meetings and presentations
Attend and provide medical support for investigator and consultant meetings and clinical advisory boards
Develop and manage relationships with key opinion leaders to obtain advice and feedback