MSI are working with a a global leader in OTC products, who are seeking an experienced Clinical professional to join their team.
The Associate Director - Clinical Research is a pivotal role and will work within a cross-functional global team and will require collaboration with a number of internal teams including Category and Regional Medical Affairs, Clinical Operations, Pre-clinical, Regulatory, Innovation, Statistics & Data Management as well as external groups, Clinical Research Organizations (CRO) and Health Care Practitioners (HCP) to help achieve company objectives and to build and maintain reputation.
- Provide scientific and technical input to category/sub-category clinical development plans.
- Responsible for the design, implementation, reporting, interpretation, disclosure, and publication of clinical studies detailed in Clinical Development Plans
- With support from Category Clinical Research Directors and Head of Clinical Research, design fit-for-purpose clinical strategies and other clinical evidence generation strategies to support the business. You will contribute to a diverse range of studies such as proof of concept, RCTs, post-marketing support including use of Real-World Evidence/Real World Data.
- Implement novel research methodologies in line with external e.g. ICH GCP, , and internal policies e.g. Medical Governance , as appropriate to generate clinical evidence for impactful claims in support of successful product launches, brand positioning and messaging
- Align the Clinical strategies to the type of planned regulatory submissions such as 505 (b)(1), 505(b)(2), Bibliographic, Full/ Full-Mixed, Hybrid applications. Develop in-depth understanding and keep up to date with the regulatory requirements of US FDA and EMA within the scope of assigned category impacting clinical studies.
- Responsible for contributing clinical content to regulatory submissions by preparing or updating the Clinical Sections of CTD dossiers including Clinical Overview, Clinical Efficacy and Safety Summaries, or by providing vendor oversight for delivery of such activities.
- Actively engage with Regulatory teams for US and/or EU Scientific Advice meetings and their preparatory activities including the preparation and update of clinical sections of Briefing package
- Responsible for supporting clinical/medical due diligence for external opportunities from a clinical research point of view.
- Work closely with the pre-clinical and Pharmacokinetic teams to ensure pre-requisite data are available to progress clinical activities.
- Work closely with Statistical teams by providing Clinical inputs for effect size, clinical significance, non-inferiority, or equivalence margins as required. Provide inputs to Statistical Analysis Plans for Clinical studies.
- Keep up to date with relevant therapeutic/ scientific literature and provide clinical expertise to facilitate preparation of clinical development and therapeutic strategies for all categories.
- Support publications to ensure that they are scientifically robust from a medical and scientific standpoint.
We are looking for professionals with these required skills to achieve our goals:
- Master's degree in a relevant discipline such as medical or clinical science
- Experience in the clinical development/drug development/OTC Drug development process.
- Experience in the Pharmaceutical or healthcare industry. Consumer Health care experience is greatly preferred.
- Experienced in and with record of delivering clinical development programs/clinical studies/clinical evidence generation activities such as randomised controlled trials, Real World Evidence (RWE) studies.
- Experience in regulatory / health authority interactions on clinical designs/submissions.
If you have the following characteristics, it would be a plus:
- PhD (or equivalent) in a relevant discipline
- Experience within Pain relief or OTC Drugs
- Demonstrated experience representing an organization with external stakeholders.
- Demonstrated competent business acumen.
- Excellent verbal and written communication skills in English
- Strong computer literacy including competency in Microsoft Office software.