Description
Global pharmaceutical company is looking for an experienced scientist to provide strategic direction to project teams and influences strategy during discovery and/or clinical program.Responsibilities
1. Independently represents PK Sciences a core member of discovery, translational medicine and global project teams.
2. Participates or leads PKS sub-team to define PKS strategy for compound progression and development.
3. Manage study timelines, objectives and budgets, ensures accuracy of project progress in company tracking tools.
4. Accountable for the timely and effective communication of data, strategy, results, impact to the project teams.
5. Ensure alignment of plans and strategies with sub-teams, project teams, manager and leadership team.
6. Analyze and interpret PK/TK/PD/IG data generated during discovery, early and full development; present results and implications to the program.
7. Proactively identifies potential project hurdles, provides solutions and implements contingency plans.
8. Authors and prepares key pre-clinical and clinical, and regulatory documents including , but not limited to: clinical study protocols, clinical study reports, modeling reports, investigator brochures, IND / IMPDs and NDAs within agreed timelines, and meeting all regulatory requirements.
9. Leads cross-departmental teams, department-wide initiatives and work streams.
10. Provide PK Sciences expertise on due diligence and prepare appropriate documentation.
Requirements:
* PK/TK study design expertise
* Regulatory knowledge of area of CP & Biopharmaceuticals
* Pre-clinical study design
* Clinical study design
* CP strategy, discovery characterization
Education:
PhD / Pharm.D. level scientist with relevant experience in drug metabolism and pharmacokinetics or related biologic back ground.
10 + years of experience in drug discovery, development or a relevant environment (e.g. Clinical
Pharmacology or Drug Metabolism and Pharmacokinetics).
2. Extensive and in-depth knowledge of drug metabolism and pharmacokinetics including,
pharmacology PK and PK/PD evaluation, Immunogenicity (for PTM roles), techniques, experience in working in project teams awareness of recent developments in drug development sciences.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.