Essential Functions

Manage the expectations/timelines with regards to assigned TM&S work for the relevant project teams.

Support M&S global head to manage/oversee outsourced work with collaborating CROs for TM&S work.

Support global head of M&S in the development/update of appropriate internal procedures to manage TM&S work.

Contribute to the establishment of QSP, PBPK and translational PK/PD approaches as a core competency for pre-clinical and clinical development in line with best practice recommendations.

Plan, perform, QC and report translational PK/PD, QSP and PBPK analysis to support clinical programs as needed.

Analysis and reporting of results from translational PK/PD, QSP and PBPK data analysis and interpretation with project statistician and other relevant team members.

Provide expert support to others within Global CPhS including Clinical and Translational M&S, DMPK and project teams with respect to the design and analyses of translational PK/PD, QSP and PBPK analysis.

Prepare and review TM&S components of Clinical and Drug Development Plans for assigned projects.

Review preclinical/clinical data from projects based in-house or for potential in-licensing candidates (due-diligence).

Draft and/or review TM&S aspects of Investigator Brochures, IMPDs, and relevant sections of submissions documents (CTDs) and other Regulatory documents for assigned projects.

Provide Clinical Pharmacology support to Clinical Research and Development Teams (protocol development and review, report preparation and review, data review and interpretation) with respect to M&S/PBPK aspects.

Provide scientific leadership for regulatory documents creation (e.g. briefing books, global submissions, Clin Pharm module 2.7.2, etc.)

Represents TM&S/CPhS in discussions with Health Authorities

Participate in product labelling to ensure that the label is consistent with Clinical Pharmacology/TM&S data.

Where appropriate work closely with discovery researchers to define clinical surrogate markers of efficacy or toxicity for early phase studies.

Keep up to date on best current practices and knowledge in the fields of pharmacometrics, QSP and PBPK by attending training courses, conferences and reading relevant literature.

Continue to enhance collaboration with DMPK and discovery

Support the future success of Translational M&S

Acts as a mentor and coach to TM&S team members, mainly for QSP and PBPK.

Essential Functions when assigned direct reports

Manages individual Associate Director and/or Director TM&S contributors both locally and remotely.

Manage all TM&S employee-related activities throughout the year, including performance management and development.

Formally or informally assesses talent in function and enables career development opportunities for all team members.

Enables employees' career aspirations by encouraging an open discourse about career aspirations to guide employees‘ careers within Company and facilitate the transition of employees into their desired roles.

Leads recruitment, selection and succession planning for assigned staff

Responsible for compensation planning for assigned employees

Requirements

MD/PhD/and/or PharmD

Extensive experience in QSP and preferably in PBPK as well

Extensive experience in pre-clinical and clinical research methods and processes in industry setting required.

Advanced competency in Study Design and Execution

Expert Functional Technical Competency in Clinical Pharmacology Study Components, Drug Development Plan, Translation Medicine Principles, and Regulatory Management.

Expert Business Knowledge, Therapeutic Area Knowledge, and Regulatory Knowledge

Expert Project and Resource Management