Medical Director

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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.

Position Overview:

The Medical Director 1/Medical Director 2 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. Seeking hematologist/Medical Director with experience in hemotology clinical trials.

Responsibilities include, but are not limited to the following:

• 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

Skills/Qualifications/Education Requirements: 

(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) 

• Medical Degree with completed residency training and at least 2 years of post-residency clinical experience in a broad area of indications.
• Typically requires 8 years of clinical research experience with minimum 5 years of experience in the pharmaceutical or biotech industry, either in early clinical development / translational medicine or in pivotal development in internal medicine, immunology, hematology, and oncology.
• 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

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 degre