Associate Director, Clinical Development

Associate Director, Clinical Operations

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

 

Summary:

Oversees the clinical feasibility assessment and strategic planning of clinical trial programs or studies.  Executes on these global programs or studies in one or more assigned therapeutic area(s) from DP1 and up to the market authorization.  Manages budgets, timelines and quality of deliverables for assigned program(s) and study(ies). 

 

Primary responsibilities for role 

● Develops and manages clinical development program plans (e.g., strategies, budgets, timelines).                    
● Provides clinical input/review to clinical documents and ensures the integrity of clinical data prior to submission to regulatory authorities (e.g., protocols, investigator brochures, clinical study reports).                    
● Manages clinical timelines, budgets, and resources against the approved CDP in collaboration with contract manager.                    
● Oversees third party vendors (e.g., contract research organizations (CROs), central labs) and trains them on SOPs, as necessary.  Manages the vendor's performance, including on time study completion, budget adherence, and quality deliverables along with the senior management.                     
● Participates in development of vendor specifications to ensure accurate interpretation of the protocol requirements (e.g. processes and data collection)            ● Drafts clinical components for DP1-DP5 gates and liaise cross-functionally to provide clinical input on all development stages (DP1-DP5) and TPP, as necessary.                    
● Provides oversight and collaboration with Biometry to ensure timely data transfers for data cleaning, review and analysis.                    
● Collaborates with Manager, Clinical Supplies to ensure timely manufacturing, packaging, labeling, shipping of clinical trial supplies for which the incumbent is responsible.                    
● Manages responses to audits, as necessary.                    
● Develops program/study status presentation materials during internal management and advisory meetings.                    
● Maintain awareness of SAEs that are reported                     
● Identifies risks, mitigations, opportunities and contingency plans for assigned program(s) and study(ies).                    
● Manages direct reports through performance evaluations and addressing professional development.                    
● Offers guidance to resolve escalated study conduct issues and provides clinical responses to questions from study center personnel, regulatory authorities and institutional review boards/ethics committees.                     
● Escalates significant issues on program(s) and study(ies) to senior management in a timely manner.                    
● Participant and contributor to internal and external training for clinical program (e.g. Kick-off meeting, Investigator meeting)                    
● Attends cross functional project team meetings.                    
● Maintains good knowledge of the literature for the indication being studied and reviews and summarizes relevant literature for the therapeutic area of interest, as necessary.     

 

Knowledge, Skills and Abilties   

Good knowledge of good clinical practices (GCPs), code of federal regulations (CFRs), ICH, and clinical trial management including monitoring  and study management processes, regulatory requirements, drug safety requirements, data management and statistical processes, budgets, and financial tracking. Good project management skills, including effective planning and organizational skills. Good leadership skills in supervising direct reports and defining strategies for efficient program/study execution.  Good verbal, written and interpersonal skills as well as motivational, decision-making and issue resolution skills. Good ability to recognize cultural and regional differences that affect medical standards and patient care. Good ability to manage multiple programs/studies. Good ability to prioritize and effectively manage changing priorities.

 

Education

Bachelor’s degree in life sciences or Master’s degree in biomedical science.