Clinical Development Senior Manager - Vacatures

Location: Science Park, Cambridge (Hybrid working) Job type: Permanent At Mundipharma, we are proud of the work we do to bring innovative treatments to patients.
We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.
This is an exciting opportunity to work on rezafungin, a novel anti-fungal agent recently approved in multiple territories for the treatment of candidaemia/invasive candidiasis, and in late-phase development for the prevention of invasive fungal infections in patients undergoing allogeneic blood or marrow transplant.
The successful applicant will be responsible for leading medical monitoring activities for ongoing clinical trials; providing clinical and scientific expertise in the design, execution and interpretation of clinical studies throughout the product lifecycle; and providing expert clinical and scientific input into regulatory documents as required.
Role and responsibilities 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.
Leads Medical Monitoring activities, including interacting with clinical trial sites, reviewing patient data, raising and responding to queries, and preparation for Data Review Committee and Data Safety Monitoring Board meetings.
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 questions from regulatory authorities etc.)
May represent Clinical R&D at internal (e.g.
governance) and external (e.g.
Regulatory agency) meetings.
May represent Clinical R&D in meetings with key external experts (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.
What you'll bring Relevant medical degree (M.D.)
Clinical drug development experience demonstrated within a pharmaceutical, biotech or academic research environment Therapy area knowledge of Anti-infectives is desirable.
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.
What we offer in return flexible benefits package opportunities for learning & development collaborative, inclusive work environment Diversity and inclusion Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority.
We believe this isn't just the right thing, but also the smart thing to do, as we focus on making a positive difference for our customers and their patients.
About Mundipharma Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.
Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe debilitating disease areas.
Our guiding principles, centered around Integrity and Patients-Centricity, are at the heart of everything we do.
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Additional Job Description: Primary Location: GB Cambridge Job Posting Date: 2024-07-30 Job Type: Permanent