Director of Clinical Pharmacology & Translational Medicine
A global and leading pharmaceutical company is currently recruiting for an Associate Director/Director Clinical Pharmacology and Translational Medicine position. Based in the UK, Hatfield, this is an exciting opportunity to bring expertise and skills to an established and in-demand company that specialises in oncology and neurology.
- Provide direction, planning and execution of the Clinical Pharmacology programs integrating novel translational biomarkers and quantitative modelling/simulation in the clinical development programs.
- Active contributor to the cross-functional teams, providing innovative and progressive thinking to projects and where appropriate provide guidance to other team members.
- Act independently, within a matrixed clinical development organisation and must have the experience and conviction to provide sound input to various project teams about clinical pharmacology, translational and quantitative activities.
- Driving the development and execution of the Clinical Pharmacology strategy for small and large molecules in drug development and delivering key components of the Clinical Development Plan.
- Providing scientific leadership on Clinical Pharmacology strategy and translational science to cross-functional project teams.
- Working with clinical development and/or program teams to achieve program goals and provide deliverables in approved timeframes.
- Designing and implementing Clinical Pharmacology studies that allow early go/no-go decisions, incorporate innovative clinical development strategies and support competitive drug labels.
- Leading the integration of modelling & simulation (PK/PD) and PGx activities in the Clinical Pharmacology programs.
- Serving as a Study Director/Clinical Pharmacology lead and driving the execution of the protocol concept to final report including interpretation of clinical data.
- Creating and maintaining internal and external networks to maintain cutting edge knowledge of Clinical Pharmacology approaches and to implement novel designs in the clinical trial.
- Representing and leading clinical pharmacology contributions to all regulatory documents including Investigator Brochures, EOP2 meetings, Type C, NDA meetings. Leading the resolution of clinical pharmacology queries from drug regulatory agencies and taking a lead role in writing and reviewing responses to regulatory queries.
- Providing recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc.) to the clinical and project teams and in regulatory documentation.
- Maintaining extensive scientific awareness and presence in Clinical Pharmacology, publishing multiple manuscripts and posters, and Presenting at Scientific Conferences and other scientific forum.
Skills and Requirements:
- MD or PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, or other related field.
- Demonstratable experience in pharmaceutical or biotechnology industry with a broad and proven understanding of drug development.
- Self-motivated, able to work in cross-functional global teams and have a strong work ethic and integrity.
- Must possess outstanding verbal and written communication skills and be able to build relationships and influence decision-making, while managing tight timelines.
- Experience interacting with regulatory agencies including being directly involved in the review process. Must have been directly involved with successful major regulatory filings.
- Expertise in providing CRO and consultant oversight.
- Experience in neuroscience and translational science is not required but strongly preferred.
- Experience internal medicine, pediatric indications is also preferred.
- Strong interpersonal skills with an ability to communicate across different levels
- Diplomacy and rationale in difficult situations.
- Ability to handle many tasks and setting shifting and competing priorities.
- Maintain confidentiality, particularly related to employee personal information.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Josh Godden on +44 203 854 0101 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.