Macrophage Pharma is an early stage, UK headquartered drug development company, applying a proprietary and clinically-validated medicinal chemistry approach (Esterase Sensitive Motif, ESM) to target small molecule drug candidates to macrophage and dendritic cell populations in oncology indications. Macrophage Pharma has the key objective of rapidly developing a portfolio of products to address significant unmet need through improving patient responses to existing immunotherapies.
The Clinical Development Manager will be responsible for operational management and delivery of Macrophage Pharma’s clinical development programmes; coordinating with the Programme Development Manager and project development team. They will work on the planning, design, implementation, execution and reporting of national and international clinical trials in collaboration with internal and external partners. They will manage the clinical development activities carried out by CRO partners, ensuring that clinical projects progress on time and in budget whilst ensuring compliance with SOPs, EMA and FDA regulations and ICH/GCP guidelines. They will travel as required to carry out project tasks. These tasks will include attendance and presentation at Investigator Meetings and attendance at site visits, including site initiation visits and co-monitoring visits.
As with any position in a small, start-up organisation, the precise role and responsibilities of the appointed candidate will evolve over time and in finding a Clinical Development Manager, we need somebody who is comfortable working in a flexible, fast-paced environment.
- Project management of clinical product development plans
- Oversight and assistance in the preparation, review and approval of clinical study documents (e.g. agreements, protocols, information sheets and consent forms, case report forms, lnvestigational Medicinal Product labelling, sections of Investigator Brochures, ethics submission documents and clinical study reports)
- Identification, assessment and management of external service providers throughout the life of assigned clinical trials
- Selection of investigational sites with input from the Development Director and external service providers
- Oversight of investigative sites' adherence to regulations through review of monitoring reports, co-monitoring visits, GCP audit reports and communications with investigators, study site personnel and clinical research associates
- Lead review of data to ensure quality and consistency and ensure that adverse events are reported in accordance with MPL procedures and to satisfy ethical and regulatory requirements
- Oversight of the submission of trial-related and essential documents to the Trial Master File
- Set up and maintenance of internal GCP compliant quality system and participation in internal and external audits
- Plan and conduct investigator meetings and advisory boards
- Participate in budget development and management and oversee site budget negotiation process
- Project reporting to the Executive team, including identification of clinical risks and contingencies
- Postgraduate qualification in life sciences preferred
- Significant experience in clinical operations including strong clinical project management skills with the ability to drive recruitment
- Proven experience in working with third party vendors, and being responsible for oversight, support and surveillance of the tasks assigned to the CRO
- Knowledge of ICH and GCP guidelines and other regulations applicable to clinical trial management
- Experience of oncology therapeutics product development
- Experience of small molecule drug development
- Excellent problem solving and analytical skills
- Strong verbal and written communicator
- Good attention to detail
- Experience of budget management
- Self-motivated with ability to work independently with moderate supervision
- Ability to perform in a small (virtual) company environment with an ability to work flexibly, independently and remotely
Remuneration to comprise salary commensurate with experience, performance related bonus, matched pension contribution and share options.
Please apply with covering letter and CV to email@example.com