Head- Preclinical Job in Venus Remedies Limited

0">Mandatory Qualifications

PhD/ Post doc in pharmacology or pharmacokinetics or a biological or related discipline (e.g. biology. biochemistry, pharmaceutical science).

Work Experience in Relevant Field

08-10 Years

0">Technical Skills Required

Sound knowledge of Preclinical Pharmacokinetics and Pharmacodynamics, Pharmacometrics and Toxicology responsible for the design, pharmacokinetic analysis, and reporting of non-clinical animal pharmacokinetic, toxicokinetic, and ADME studies.

Experience with PK software and have an understanding of non-compartment & multi-compartment modeling

Do Scientific Writing for creation of preclinical paper publication, reports review, preparation of preclinical overall summaries and other regulatory activities.

Responsible for planning, conducting, and reporting the study to regulatory, maintaining the integrity of preclinical data, and for ensuring that project timelines are met.

Responsible for the oversight of external pharmacokinetic studies, establish deliverables, maintain timelines, and foster open communication with and between the Project Teams, Preclinical Operations and other Functional Heads.

Responsibilities will also include reviewing and providing content and subject matter expertise relating to preclinical pharmacokinetics, toxicokinetics, efficacy and ADME sections of regulatory documents to include: INDs, BLAs and other regulatory submissions and responses, as needed.

Participating with group members to explore innovative and improved ways for meeting the group's deliverables while contributing to the scientific depth of the group.

Effectively manage the preclinical PK team tasked with study design, protocol development and study execution of GLP and non-GLP pharmacokinetic, toxicokinetic, and ADME (as needed) studies, with competing and aggressive time lines, prioritizing activities, and working independently.

Supervise, assist, and mentor contributing scientists on pharmacokinetic, efficacy analysis, data interpretation, and report writing.

Empower subordinates and provide for the professional development of their staff.

Functions as study director or principal investigator responsible for externally conducted PK, and ADME (as needed) studies as appropriate.

Interact closely with other managers and contributing scientists tasked with bioanalytical assay development, and/or sample analysis to ensure seamless and timely transfer of bioanalytical and ADA data to the Preclinical PK/PD team.

Comply with all pertinent SOPs and GLP regulations with responsibility to face audits, theri preparedness and compliances

Effectively communicate project team queries, requests and expectations (i.e. timing, budget and deliverables) from the Project Functional Teams to subordinates and management.

0" class="ng-scope">Who You'll Work With

Preclinical

0">What You'll Do

Build a highly talented team to drive successful integration of objectives. Coach and develop staff; engage in the recruitment, training and retaining talented scientific pool and provide cross-training wherever required.

Mentor and coach the existing team and developing a pipeline of high caliber and talented professionals with right skill sets. Drive career advancement plans, objective / goal setting, deciding on the Goals & Objectives for direct reports and ensuring a similar approach for down the line reporting in the organization.

Structure /improve processes and systems to ensure operational excellence in the organization.

Develop productivity metrics and initiatives to improve productivity year on year through combination of talent, processes and technology.

Direct and guide the team to engage in proposal writing, contract negotiation, technical presentations, and support of third party/ interdepartment relations.

0">Soft Skills Required

Excellent communication skills in both written and verbal form are a must have for the Head of PC