Director of Clinical Pharmacological & Translational Research - United Kingdom
Support drug development programmes with scientific and strategic input for biomarker analysis, PK/PD modelling and drive translational research strategy
Support Asset development including POC study design, strategy for patient stratification and biomarker development.
Manage a team of Clinical Pharmacologists, PK / PD Experts and Translational Researchers.
Lead translational research considerations and biomarker development for our developments assets.
As Soon As Possible
- Build a group of high – performing PK, PK/PD and translational researchers.
- Support team in designing Proof-of-Concept clinical studies with respect to biomarkers (imaging, liquid, efficacy), PK-PD and translational research considerations
- Support team to design and conduct PK/PD studies and efficacy studies for translational research and for decision-making on dose selection
- Support team in analysis, evaluation and recommendation of biomarker studies in the development process
- Enable close collaboration on the identification of novel therapeutic concepts (External R&D, Academic Alliances)
- Provide strategy for dose selection in preclinical studies
- Support asset team on dose prediction (pre-IND) and for dosing recommendations in preclinical and clinical studies
- Contribute to design and evaluation of biomarkers studies
- Support of due diligences, e.g. analysis and evaluation of existing PK/PD data including gap/opportunity analysis for further clinical development
- Drive discussion on POC studies, Biomarker studies and Biomarker development.
- Lead analysis, evaluation and recommendation of biomarker studies in the development process
- Be accountable for budget planning
- Support teams in designing Proof-of-Concept clinical studies with respect to biomarkers (imaging, liquid, efficacy), PK-PD and translational research considerations
- Support teams to design and conduct PK/PD studies and efficacy studies for translational research and for decision-making on dose selection
- Close collaboration on the identification of novel therapeutic concepts (External R&D, Academic Alliances)
- Identify potential clinical readout parameters and methodologies for differentiation of existing molecules in our portfolio of R&D development pipeline (additional benefit for health economy considerations).
- Analyse, evaluate and propose additional clinical indications for existing compounds (Life cycle management) based of mechanism-based considerations.
- Lead discussions on translational aspects for pre-clinical and early clinical studies (supporting the three pillars of drug development, e.g. drug exposure, target engagement and functional modulation)
- Explore biomarkers to guide product development and patient stratification with the ultimate goal of enabling personalized medicine.
- Provide ongoing scientific input on development projects
- Engage with External R&D and IACs in strategic initiatives to support the business of the European region and to enhance the global interaction.
- Support in-licensing activities of Business Development Projects.
- Responsible for people development with the group to assure high quality results and efficient processes.
- Accountable for identifying and implementing best strategic and operational practice, identifying risks and issues which impact on project progress.
- Establish a leadership culture of organisational performance and deliver, by focusing on high-priority core activities and behaviours to help build and shape the business that will drive the future success of the company.
- Attend and participate in appropriate learning events for both personal and professional development.
- Undertake any other reasonable tasks as required.
A. Qualifications & Experience
- Biomarker studies (PET, fmRI, MRI) and Biomarker development (Liquid biometrics for diagnostic and / or therapeutic purposes)
- Chem Pharmacology and PK / PD expertise
- Qualified Physician with specialisation on pharmacology and toxicology.
- Significant experience in medical research and pharmaceutical or biotechnological industry, especially in pharmacology, pharmaceutical technology and clinical sciences (minimum 10 years).
- Affiliation at a Medical University, ie habilitation or professorship.
- Profound understanding in leading of projects and working within matrix structures.
- Understanding of the industry trends and emerging issues in Europe, Asia Pacific and Latin America, including social, economic and regulatory factors that might impact the delivery of successful outcomes.
- Significant experience in strategic planning, coupled with successful implementation of processes.
- A demonstrated ability to effectively manage internal and external relationships.
- Ability to work effectively through teams to achieve results; evidence of developing the talent of others, ability to mentor.
- Cultural sensitivity gained from experience within diverse environments.
B. Personal & Leadership Characteristics
- Exemplary leadership skills with both practical and short/long term strategic vision; ability to build relationships and inspire confidence and respect at all levels; strong team player.
- Excellent communicator – able to build rapport and demonstrate strong influencing and negotiation skills; excellent listening skills - receptive to feedback and demonstrates flexibility, curiosity and an ability to learn.
- Demonstrates and encourages ownership and responsibility; drive/motivation - has a “can-do” attitude and is committed to delivering results and strives for continuous improvement.
- A good blend of strategic and analytical thinking; innovative personality; able to see the bigger picture and set direction for the future.
- Consistently demonstrates and encourages others to demonstrate the Company’s Core Values; Honesty, Respect, Passion, Innovation, and Commitment.
- Strong ethical standards and a high level of personal integrity.
- Adheres to the Company’s Compliance and Code of Business Ethics guidelines.
|Adress:||Mundipharma Research Ltd |
F.A.O - Natalie Carvalho
196 Science Park