- Representation of LF on cross-functional Project Teams (NIBR and Development) in-volved in the development of Biologics drugs
- Negotiate an optimal nonclinical and clinical PK/PD strategy in liaison with appropriate line functions and with Management input as appropriate.
- Responsible for the PK and PK/PD component of nonclinical and clinical protocols, reports, project summaries and development plans within agreed timeframes and which meet regulatory requirements.
- Prepare appropriate responses to HA inquiries (globally).
- Interpret and present project related study results and recommendations to Project Teams, DMPK Management Team and HAs.
1. Assures support to all assigned projects is optimal in quality, timing and cost.
2. Facilitates constructive collaboration within the LF and project teams.
3. Identifies potential project hurdles, suggests solutions and establishes priorities and con-tingency plans in collaboration with LF management.
4. Responsible for the compilation, seeking of approval and updating of LF specific devel-opment plan to support the TPP.
5. Monitors study timelines, objectives and budgets, ensures accuracy of Succeed plans and assures rapid and effective communication of data to project teams.
6. Manages and coordinates relations with regulatory authorities in collaboration with LF management and DRA.
7. Leads or participates in project sub-teams and/or LF specific teams.
8. Evaluates in-licensing opportunities and carries out Due Diligence activities as required.
9. Manages the preparation/presentation of all internal and external (e.g. Investigator?s Bro-chure, IND, CTD) documentation under appropriate supervision / mentorship.
10. Maintains scientific and regulatory expertise in the field of representing LF (e.g. training courses, external meeting attendance).
Education: PhD in natural /biological sciences, DVM, PharmD or equivalent with biological background or equivalent on the job training.
Languages: Fluent English (oral and written).
Experience: 1. Minimum of 3 years' experience in the development of biologics (antibodies, therapeutic proteins, peptides etc) across multiple therapeutic areas. Experience with the development of biologics for the treatment of ophthalmological disorders is desirable
2. Advanced knowledge of the PK/PD and immunogenicity of biologics
3. Proficient with full range of techniques used in job and core area.
4. Ability to manage conflicting expectations in a matrix environment.
5. Excellent project management skills.
6. Team player with experience of interactions with toxicology, pharmacology, clinical and regulatory affairs groups.
7. Excellent knowledge of drug development guidelines.