Sr. Medical Director

Location: 

NC-RTP, US

Contract Type:  Regular Full-Time
Area:  Clinical Trials
Req Id:  468787

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

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:

Drives medical strategy for clinical development research portfolio across programs. Assesses clinical feasibility and strategic planning of clinical trial programs/studies in various assigned therapeutic areas. Executes and moderates investigator/medical advisory meetings with clinical experts and serves as the clinical internal expert in the assigned area. Initiates the set up of the clinical study, including generation of final protocols, case report forms, investigator brochures and reviews other study start up documents (e.g., informed consents, study manuals) generated by study managers and department management.

 

Responsibilities include, but are not limited to the following:

● Interfaces with clinical investigators and internal teams with the goal of execution of clinical programs/studies according to GCP.  Orchestrates expert meetings to elucidate the best clinical path forward for a clinical program.

● Develops study outlines, protocols, amendments and investigator brochures.

● Contributes to corporate strategy for new investigational programs or additional indications

● Authors portions of Common Technical Documents and regulatory responses

● Works with statistics to plan how the data will be analyzed and is responsible for the interpretation, analysis, writing and production of clinical research medical reports and other clinical research documents.

● Authors briefing booklets, drug safety board charters, clinical sections of regulatory submissions and slides for presentations to internal and external groups.

● Partners with department managers to trouble shoot study protocol issues as they arise and provides clinical responses to questions from investigators, site coordinators, health authorities and institutional review boards.

● Authors draft publications from clinical study data and white paper literature reviews on new products or safety questions.

● Participates in cross functional project teams and presents information to internal and external audiences.

● Authors clinical SOPs and contributes to clinical department process improvements.

● Participates in health authority meetings with FDA or other regulators and oversees the documentation submission process to regulators.

● Conducts and provides status updates to internal project teams to ensure development strategies are continually valid and on track.

● Manages serious adverse event narrative production and quality control, coding of adverse events, medication and patient history terms.

● Converts clinical development plans into project implementation plans and clinical trial development. Studies design, outlining, and protocol development.

● Contributes to regulatory document creation.  Writes and updates the Investigator’s Brochure, FDA Target Product Profile Document, and Clinical Development Plan. 

● Conducts due diligence evaluation of assets for business development. 

● Participates in health authority meetings with FDA or other regulators and oversees the documentation submission process to regulators.

 

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 required
  • Typically requires 15 years of clinical research experience including IND (or equivalent) and Phase 1 through Proof of Concept/Phase 3 pivotal studies with at least 8 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 medical field. Expert knowledge of Good Clinical Practices (GCP), federal regulations and international regulations (International Harmonization Committee-ICH regulations)
  • Expert 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
  • 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

*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.

 

 

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

Location: NORTH AMERICA : USA : NC-RTP:USHOME - Home Address 

 

Learn more about Grifols