Associate Director, Translational Medicine

Grifols

Dublin, Ireland

POSITION SUMMARY:

The Associate Director of Translational Medicine bridges drug discovery (by application of preclinical studies) to clinical programs. The key roles of this position are to define translational strategies, manage external partners and ensure scientific rigor for decision making in drug development. The Associate Director of Translational Medicine focuses on biomarker discovery, assay development and clinical trial support by working closely with the discovery, pharmacology, clinical development and regulatory teams to advance therapeutic programs.

What You Will Do:

Develop and implement scientific strategy of translational medicine studies, interpret data to support of program objectives;
Discover, validate, and implement biomarkers to assess drug response, understand mechanism of action, and biomarker measures for animal and patient studies;
Prepare IND supporting documentation and participate in pre-IND meetings with regulatory authorities;
Defines and executes strategic plans for translational science projects that are aligned with regulatory expectations;
Manage external partners like Contract Research Organizations (CROs) to ensure high quality and timely study execution;
Initiate new areas of investigation and implement cutting-edge technologies that are scientifically meaningful, reliable and can be incorporated directly into both preclinical and clinical development programs;
Present scientific findings internally and externally;
Designs investigative translational strategies in support of research, preclinical and clinical development as well as regulatory strategies;
Leads the planning and implementation of experimental programs, with internal (Grifols) or external stakeholders, in support of asset readiness for clinical development phase;
Directs and coordinates experimental programs, with internal (Grifols) or external stakeholders, in support of asset readiness for clinical development phase;
Interprets, synthesizes and communicates preclinical and clinical biomarker study results to support key program decision making;
Provides scientific, technological and strategic guidance to biomarker and/or bioanalytical programs accompanying clinical trials in collaboration with nonclinical and clinical teams;
Contributes to the creation of study-level documents, including review/preparation of non-clinical sections of key regulatory documents, such as protocols, Investigator’s Brochures,briefing meeting request & package and submission dossiers;
May participate in due diligence assessments of potential external assets and participate and ISR evaluations;
May represent Grifols at external functions such as conferences;
May manage a team of scientists and research associates;
rives TM program evaluations within a multifunctional team and presents business opportunities the Senior Management;
Works closely with Quality Management & Assurance to ensure work conducted by qualified vendors;
Assesses/implements departmental standardizations for new and improved practices and or consistent work practices, and SOPs;
Serve as a subjectmatter expert providing scientific guidance and support to project teams;
Provides translational teams leadership and develops teams with technical depth;
Contributes to developing and executing work in support of corporate goals;
Developing and managing vendor budgets.

What You’ll Bring

Excellent knowledge of relevant diseases and biological processes;
Excellent and demonstrated project management skills. Excellent oral and written communication skills;
Communicates complex technical and business information to technical and/or non-technical audiences as well as upper management;
Ability to interpret data, identify errors and provide corrective actions to procedures and processes to generate valid conclusions;
Expertise in setting and meeting deadlines, multitasking, as well as identifying, requesting and prioritizing team resources based on project needs;
Ability to anticipate future change and recommends strategies for optimizing processes and procedures that will mitigate long-term foreseeable problems;
Demonstratable deep knowledge ofrelated field principles, tools, and/or databases;
Adaptability to change in priorities;
Consistently motivated, even under difficult situations;
Excellent team player that creates an atmosphere for collaborative effort among the team;
Ability to articulate strategic options and scenarios to inform operational delivery of the project(s), understanding how to focus on the delivery of goals and contributes strategic insights to prioritization and decision-making;
Makes solid decisions based on a combination ofanalysis, experience and professional judgement;
PhD orMSin Biology,Biochemistry, Immunology, Biological Engineering or related field;
5-8 years of related experience;
Depending on the area ofassignment,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.