Clinical Scientist - Anti-infectives

Job Description

Company Description Mundipharma is a global (ex-US) network of independent associated companies that research, develop and manufacture innovative pharmaceutical medicines and consumer healthcare products. We are an agile and fast-paced company seeking to increase access tohealth care through programmes and effective partnerships.We are forward-looking and dedicated to bringing innovative treatments to many of the worlds most challenging conditions and diseases including: Pain Management & Supportive Care, Consumer Health, Anti-Infectives, Biosimilars, CNS, Diabetes, Oncology, Ophthalmology,Respiratory and transplantation immunity.We make a difference to patient lives by delivering value to healthcare professionals in 120+ countries across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.Our guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything we do. We encourage our people to think differently and our inclusive culture of continuous learning and collaboration make Mundipharma a great placeto work. Job Description

• This is an exciting opportunity to work on rezafungin, a novel anti-fungal agent in late-phase development, the Clinical Scientist is responsible for providing clinical and scientific expertise in the design, execution and interpretation of clinical studiesthroughout the product lifecycle.
• The Clinical Scientist ensures appropriate clinical and scientific input into Regulatory strategies and Regulatory documents as required.The Clinical Scientist provides clinical development and scientific evaluation of business development opportunities in the anti-infectives area, as a key member of the Due Diligence team.

Key Responsibilities & Expectations

• Supports the Global Clinical Lead, in providing clinical science input to the clinical development plan (CDP) for rezafungin; may act as the Clinical Lead for some aspects of the programme.
• Provides scientific and clinical interpretation of clinical trial results, working closely with statistical colleagues, supporting (or leading, as required) results interpretation for governance and other presentations, and for clinical study reports.
• Provides Regulatory with scientific and clinical expertise, may coordinate and write relevant sections of regulatory documentation and submissions (e.g. Investigator Brochures; Scientific Advice briefing documents etc., and provide responses to questionsfrom regulatory authorities etc.)
• Supports R&D through provision of high-quality clinical development and scientific evaluation of business development opportunities for anti-infectives at the initial triage and full Due Diligence stages, as required.
• May represent Clinical R&D at internal (e.g. governance) and external (e.g. Regulatory agency) meetings e.g. presenting clinical trial results and future plans.
• May represent Clinical R&D in meetings with KEEs and other external groups/individuals e.g. Individual site discussions, Investigator meetings etc.
• Works effectively with other functions within R&D and the broader Mundipharma business to efficiently achieve quality results and generate a high-functioning team ethos.
• Attends and participates in appropriate training courses and external Scientific/Clinical conferences for both personal and professional development.
• Commits to the management of own personal development to facilitate learning and contribution to the organisation.

Key Skills

• Strong collaborative skills, able to leverage experience and knowledge within an Asset team and wider R&D, to drive decision-making and cross-functional alignment.
• Effective communication skills with the ability to influence key internal and external stakeholders.
• Proven ability to problem-solve using available data and efficient literature analysis, ensuring a data-driven approach to issues resolution within the cross-functional Asset team.

Qualifications

• Relevant higher scientific or medical degree (Ph.D. or M.D.)
• Clinical drug development experience demonstrated within a pharmaceutical, biotech or academic research environment
• Therapy area knowledge of Anti-infectives.