Senior Clinical Development Manager

We at Orion Group are currently recruiting a Senior Clinical Development Manager on behalf of one of our Multinational Pharmaceutical clients based in Essex to work on a permanent basis.

Working closely with the development, regulatory, MSL and franchise teams, the Head of Clinical Development will oversee the design, execution, scientific advice gathering and medical writing pertaining to all clinical studies required to deliver the pipeline of life cycle management strategies, as well as novel product being licenced into the pipeline. The Head of Clinical Development will also act as the main point of interaction with external CROs, identifying best partners to appoint for trial execution and support, as well as ensuring each clinical study protocol is designed with scientific integrity with the endpoints clearly addressing the study objectives in line with the CDP and business needs. Working with the Head of Compliance the Head of Clinical Development will also be responsible for ensuring appropriate oversight to GCP and other regulatory standards of all trials including requisite record keeping and registry population.


Main responsibilities & duties:

· Direct the development of clinical strategies and plans and the design of clinical studies

· Selection, appointment and management of Clinical Research Organisation partners

· Validate study protocols and study design

· Input into drug development activities regards clinical studies considerations

· Set up or advise on the set up of study teams globally

· Provide scientific guidance and advice on studies to internal and external stakeholders

· Track the progress of studies and ensure efficient tracking and monitoring of all clinical trial data and results. Use industry KPIs to benchmark deliverables.

· Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results

· Oversee and sign off all scientific publications, set up the scientific publication and communication strategy with input from relevant functions especially the MSL and franchise teams

· Drive the KOL strategy in collaboration with MSLs and franchise teams

· Oversee Scientific Advice gathering regards protocol endorsement

· Close collaboration with the Technical team on CMC related aspects

· Close collaboration with the Head of Regulatory Affairs on all regulatory aspects with a view to timely completion of clinical development to an output that matches regulatory requirements

· Responsible for developing clinical trial budgets, close collaboration with the Head of Finance on matters related to the budgeting of CTs

· Representation of the company towards inspectors and health authorities

· Representation of the company towards investigators and the scientific community

· Team leadership and distribution of tasks

· Lead in-house and outsourced teams across multiple geographies

· Proactively identify potential issues and risks that may affect the project(s) and provide mitigation steps and viable solutions, particularly those that affect the quality and integrity of the data and safety of the product

· In collaboration with the Global Heads of Regulatory Affairs and Technical, manage clinical aspects of regulatory and technical strategies and interactions with Health Authorities

· Strong cross-functional collaboration with franchise, commercial, regulatory, quality and supply chain teams

· Any other duties as required by the CSO/CEO



Qualifications:

· Advanced Degree in Life Sciences

· Minimum 10 years in clinical development in Pharma / Biotech

· Proven track record of working and leading (a cross-functional team) in a matrix environment

· Demonstrable training in, and experience of utilizing, project management techniques in the performance of clinical trials

· Conducting oneself at all times in accordance with the Quality Management System, working practices and GCP/GcLP/GMP and other applicable regulations, and ensuring training in these areas is kept up-to-date at all times.

· Strong decision-making skills and organisational skills

· Knowledge of budgeting and tracking

· Experience within outsourcing and contracts within the Pharmaceutical industry is preferred or at least demonstrable knowledge of contracts, bid meetings and negotiations


For more information on this role, call Beatriz Olmedo on +353212063405 or email beatriz.olmedo@orioneng.com for a completely confidential chat about this role and other opportunities.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.