Head of Clinical Development

Basildon, Essex or London
Salary: Competitive + Benefits + Bonus

If you are a Clinical Development leader, experienced in defining and managing clinical strategy, then we want to hear from you!

 Join us to help improve peoples’ lives and make healthcare better for everyone!

Why Pharmanovia?

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 140 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

 Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 250 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, and South Korea.

 We are an agile and imaginative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.

Pharmanovia’s therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

About the role:

Reporting to the Chief Science Officer, you will define, implement and evaluate on an ongoing basis the Clinical Development strategy in line with corporate business goals and, together with the CSO, represent the company as a scientific expert to opinion leaders, regulators, investigators, the wider medical/academic community and to investors.

Working closely with the development, regulatory, MSL and franchise teams, you 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. You 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, you will ensure appropriate oversight to GCP and other regulatory standards of all trials including requisite record keeping and registry population.

Main responsibilities & duties:

• Directing the development of clinical strategies and plans and the design of clinical studies
• Selecting, appointing and management of Clinical Research Organisation partners
• Validating study protocols and study design
• Input into drug development activities with regards to clinical studies considerations
• Setting up or advising on the set up of study teams globally
• Providing scientific guidance and advice on studies to internal and external stakeholders
• Tracking the progress of studies and ensure efficient tracking and monitoring of all clinical trial data and results. Use industry KPIs to benchmark deliverables.
• Overseeing the analysis and interpretation of clinical trial data and the reporting of clinical trial results
• Overseeing and signing off all scientific publications, setting up the scientific publication and communication strategy with input from relevant functions especially the MSL and franchise teams
• Driving the KOL strategy in collaboration with MSLs and franchise teams
• Overseeing Scientific Advice gathering regards protocol endorsement
• Closely collaborating with the Technical team on CMC related aspects
• Closely collaborating 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
• Responsibility for developing clinical trial budgets and close collaboration with the Head of Finance on matters related to the budgeting of CTs
• Representing the company towards inspectors and health authorities
• Representing the company towards investigators and the scientific community
• Team leadership and distribution of tasks
• Leading in-house and outsourced teams across multiple geographies
• Proactively identifying potential issues and risks that may affect the project(s) and providing 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, managing 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

About you:

You will have a proven track record of effectively and positively managing people, both directly and indirectly, in cross-functional teams in a matrix environment. You will also have:

• An advanced degree in Life Sciences
• Demonstrable training in, and experience of utilising, project management techniques in the performance of clinical trials
• 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
• Determination, driven to achieve results and business minded
• A meticulous and methodical approach, with the ability to review both data and procedures in detail and the ability to see the greater overall picture

What we offer:

We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.

By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.