Associate Director Clinical Development

• Title: Associate Director Clinical Development
• Type: Permanent
• Full or Part-Time: Full-Time
• Skills Required: Real World Evidence, Clinical Trials, Clinical Data, Clinical Development, Clinical Research

Associate Director - Clinical Development

Basildon, Essex (hybrid role: 3 days office, 2 days home per week)

Salary: Competitive + Benefits + Bonus

If you are agile, committed, and experienced in the management and delivery of real-world evidence trials, with a highly analytical and meticulous approach, 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 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

Our core behaviours are:

• We keep our promises and do as we say.
• We value our heritage and foster an entrepreneurial spirit.
• We reinvest in our future - in our products, our brands and our people.
• We give back to our communities.

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 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, Spain, and South Korea.

We are an agile, committed, and innovative 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 Director of Clinical Development, as Associate Director Clinical Development you will be responsible for the overall management of clinical trials and RWE (real world data generation), from protocol development to study completion. Working closely with different departments like market access, regulatory, strategic marketing, medical affairs, etc, you will oversee the design, execution, analysis, reporting and publication of all studies (including RWE) required to deliver the pipeline of life cycle management strategies, as well as novel products and new chemical entities being licenced into the pipeline.

In your role, you will also act as the main point of interaction with external CROs, help in identifying best partners to appoint for trial execution and support, as well as ensuring each study protocol is designed with scientific integrity with the endpoints clearly addressing the study objectives in line with the clinical development/evidence plan and business needs.

Main responsibilities and duties:

• Accountability for overseeing organisational initiatives, projects, and research involving clinical trials and Real-World Evidence
• Working collaboratively with cross-functional teams to design, execute and report on real world data studies, utilising both internal and external data sources to support business decisions and generate insights
• Taking the lead in design, implementation, and analysis of studies to support strategic and business goals
• Working collaboratively with key stakeholders to identify data sources and determining study feasibility, ensuring that data is high quality, reliable and relevant to the research question
• Developing study protocols, statistical analysis plans, and data visualisation to support data-driven decision-making
• Ensuring studies are conducted in accordance with requirements like data privacy and protection
• Managing relationships with external vendors and data partners, and monitoring performance metrics to ensure quality and timely delivery of data and insights
• Staying up to date with advancements in clinical studies as well as RWE methodologies and analytical tools, and develop innovative solutions to improve study design and generate novel insights
• Communicating study results to internal and external stakeholders through presentations, publications, and other channels
• Participating in the development of scientific publications and presentations at scientific conferences
• Providing guidance and mentorship to staff members on RWE methodologies and study design

About you:

Candidates with at least 8 years' experience in clinical research (including RWE studies), or related fields, are likely to have the skills and experience required for this role, which requires an in-depth knowledge of biostatistics, epidemiology and the collection and analysis of actual data. We are also looking for:

• Bachelor's degree or higher in medicine, epidemiology, biostatistics, health economics or a related field
• Demonstrable training in, and experience of utilising, project management techniques in the performance of clinical trials (including RWE trials), as well as experience managing large scale projects
• Excellent written and verbal communication skills, including the ability to communicate complex data and insights clearly and effectively to non-technical stakeholders
• Great organisational skills, able to manage multi projects simultaneously whilst maintaining attention to detail
• Strong knowledge of worldwide clinical trials and RWE methodologies, data sources and analytical tools
• Strong knowledge of BABE, PKPD, Phase trials, Retrospective and Prospective RWE study requirements
• Demonstrable training in, and experience of utilizing, project management techniques in the performance of clinical studies and RWE trials.
• Ability to identify new data sources, Agile ways of working, and establishing the analysis of real-world evidence to drive business decisions
• Experience of budget monitoring and tracking
• Experience within outsourcing and contracts within the pharmaceutical industry is preferred or at least demonstrable knowledge of contracts, bid meetings and negotiations
• Ability to coordinate site management with research activities
• Business-minded decision-maker, determined and driven to achieve results
• Meticulous and methodical, able to work to detail but whilst seeing the greater overall picture
• Able to work effectively in a team environment in a matrix organisation
• Strong knowledge of safety and ethics

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.

If you would like to know more about Ortolan People and how we can help you reduce your ongoing recruitment costs, get in touch

We have used Ortolan's services for nearly seven years. In that time they have filled literally hundreds of vacancies for us. Whatever our recruitment needs, they have stepped up to the mark in a consistently professional manner and our long term partnership with Ortolan reflects the value we believe they add to our business..

We have used Ortolan's services for nearly seven years. In that time they have filled literally hundreds of vacancies for us. Whatever our recruitment needs, they have stepped up to the mark in a consistently professional manner and our long term partnership with Ortolan reflects the value we believe they add to our business..