Beschreibung:For one of our Pharma clients we are seeking freelance support as:Clinical Program Director Neurology (M/F/*)
Leading the development and subsequent revisions of the CDP ensuring compatibility with the TPVP and representing contemporary research approaches.
Ensuring that study concepts, Protocol Summaries and final protocols related to the relevant clinical development plans are of high quality, represent contemporary research approaches, are aligned with related CDP(s) and TPVP(s), and are appropriately managed by the clinical study teams.
Developing a strong knowledge base of the relevant disease area and therapeutics, and becoming the company expert for the respective treatment modality.
Developing and maintaining excellent working relationships and global cross functional collaboration together with all necessary stakeholders to ensure broad medical, scientific, regulatory, commercial and external input into the clinical programs.
In conjunction with the Program Physicians, overseeing an ongoing evaluation of the benefit/risk ratio of the compound.
Contributing to the ongoing safety evaluation of a product with review of and/or contributions to aggregate reports and revisions to Company Core Data Sheet and labels.
Leading the team in the planning and execution of high quality clinical components of regulatory submissions for the indication(s)/formulation(s). Responsible for on-time delivery of clinical components of regulatory submissions.
Representing the company at meetings with Regulatory Authorities, partners, conferences, and advisory boards.
In conjunction with the Publications Team, serving as co-author and/or reviewer of scientific publications of results of clinical programs.
Be responsible and accountable for all clinical aspects of their assigned program(s)/missions
Provide leadership for two programs within Epilepsy. Responsibilities include extension to 1) new formulation and 2) new region.
Lead and ensure adequate planning, design, defense, and implementation of the clinical development strategy including generation and appropriate revision of the Clinical Development Plan (CDP), clinical aspects of the Target Patient Value Profile (TPVP), and the Investigators Brochure (IB) to enable:
Successful regulatory filing, approval and launch of NCEs/NBEs, additional regulatory approvals of new line extensions (indications or formulations) of registered compounds, prompt identification of safety or efficacy results that warrant re-evaluation of project plan and/or potential termination prior to registration
Start: August / Duration: 6 months + / Location: Germany or Belgium / Capacity: fulltime
Master’s Degree required with a PharmD, PhD or MD preferred
Depending on previous professional experience, a minimum of 5 years of experience in biopharmaceutical clinical development is required, including the management of multiple clinical studies.
Knowledge with neurology/epilepsy a strong plus
Demonstrates clear and articulate verbal, written and presentation skills with excellent command of the English language and the appropriate comportment to represent company internationally at meetings and congresses.
Project management skills required. Formal project management training a plus.
Listening, coaching, mentoring, facilitation, influencing and negotiation skills.
Social skills & working style as necessary for such a position (participative, networker, matrix, results)
Bemerkungen:WANTED: Clinical Program Director Neurology (M/W/*). Please Contact: +49 89 18 90 998 11 or firstname.lastname@example.orgSkills:Clinical Project/Study Management, English, Neurology, Pharma
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