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 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
Typically requires 8 years of clinical rsearch 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
*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.
Pay Scale:
The estimated pay scale for the Medical Director (1-2) role based in the United States (non-California), is $170,000.00 - $240,000.00 per year/per hour. Additionally, the position is eligible to participate in 15% - 30% of the company bonus pool (depending on level of role). We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, 9 paid Holidays per year, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!
For Washington State:
Currently, the first year PTO accrual for this role is 160 hours per year. Then, after completion of 365 days of employment the PTO accrual for this role will increase to 180 hours per year.
For California:
The estimated pay scale for the Medical Director (1-2) role based in California, is $170,000.00- $250,000.00 per year.
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.
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
Learn more about Grifols (https://www.grifols.com/en/what-we-do)
Req ID: 528005
Type: Regular Full-Time
Job Category: Clinical Trials
