This opportunity is a key position within the cardiovascular/metabolism business unit for our client, a leading pharmaceutical company, with offices in Netherlands.
This position will contribute to the development strategy for a broad spectrum of indications within therapeutic area with an emphasis on cardiometabolic area, in order to achieve successful registration of commercially viable products.
You will contribute to the clinical development strategy and provide updated and competitive medical and scientific expertise for broad spectrum of indications, set the goals and deliverables that are in line with regulatory requirements, medical practice, business environment and latest scientific findings.
Core responsibilities include;
* Phase II-IV global and local clinical programs designed to obtain registration and market access, and to optimize the brand value during the entire life cycle, in partnership with key stakeholders from both strategic and day-to-day operational perspective.
* Prepare clinical development plans and related documents in accordance to defined global clinical development strategy in order to set a roadmap (milestones, go-nogo criteria, budget for successful registration of a commercially viable products, LCM projects and ITBs.
* Accountable for the design and management of clinical development plans based on strong medical and scientific principles, knowledge of the regulatory requirements and my client''s customers, markets, business operations, and emerging issues. Lead and manage the clinical study teams to ensure successful, timely and quality completion of the development and LCM projects.
* Contribute, as clinical development representative, to the assigned Brand Teams, to ensure strategic, scientific, medical and ethical alignment for all products. Provide clinical leadership in brand-related medical input to Therapeutic Area strategy. Serve as clinical development and medical expert on due diligence teams.
* Leading preparation and review of clinical deliverables (study outlines, protocols, reports, expert statements, clinical modules of eCTD).
* Provide clinical and medical contribution to product safety teams and product labeling teams within assigned indications/products, ensure adequate and timely medical monitoring.
* Provide clinical leadership in interaction with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal stakeholders and internal decision boards.
* MD with 5-8 or a PhD with 10+ years of experience in a position within pharmaceutical industry overseeing clinical development of a products /compounds within the target TA.
* Prior history with post-marketing/brand optimization studies to obtain evidence of brand value and support commercialization activities preferred. Additional research degree (PhD or equivalent) and/or research experience preferred.
* Proven leadership skills in a cross-functional global team environment.
* Ability to interact externally and internally to support global business strategy.
* Ability to run a complex clinical program independently.
* Extensive knowledge of clinical trial methodology, regulatory requirements governing clinical trials, and experience in development strategy and the design of protocols.
This is a freelance opportunity for an experience clinical development consultant, ideally immediately available for new contract opportunities. It offers a strong daily rate and flexibility.
For more information, call Bernardo Reveco on +44(0)207 940 2105 for more information, or alternatively email firstname.lastname@example.org with your latest CV.