Grifols has been a leader in the healthcare industry since 1909 by creating innovative products and services based on the values of ethics, quality and responsibility. Grifols' activities focus on fulfilling the needs of its patients as well as healthcare professionals working in therapeutics, pharmacy, diagnostics and blood banking. For more than 100 years, Grifols has developed, manufactured and marketed product designed to improve human health. Grifols manufactures plasma derived biopharmaceutical products of proven efficacy, quality and safety. For more information, please visit our website: http://www.grifols.com

Position Overview:

The Medical Director/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.

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.
• 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 degree with 2 years of experience.

If you have the work ethic and mental agility to embrace a fast-paced and rapidly evolving environment, you will be rewarded with diverse and exciting experiences. This is your chance to add real value to an entrepreneurial organization that supports bold innovation and new ideas. Grifols welcomes passionate, team-oriented colleagues who are looking to improve the health of patients worldwide by developing a deeper understanding of human disease.

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.

EEO Minorities/Veterans/Females/Disability

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