|Location: Cambridgeshire||Salary: £700 - £800 per day|
|Sector: Pharmaceuticals, Client Delivery, Life Sciences||Specialism:|
|Type: Contract||Contact: Zak Mendoza|
6 Month Contract
Medical Scientist or Physician needed for a multinational pharmaceutical organisation who are looking to employ an experienced and well-rounded Medical Scientist that takes pride in their work with an in-depth knowledge of development using detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research, Industry or academic experience in drug development and Drug Development/Clinical Development Planning: Demonstrates the ability to undertake the planning, and timely organization of components of the clinical development plan and work with other functions to achieve successful study initiation and execution.
What the role entails:
- Some of the main duties of the Medical Scientist will include:
- Work cross functionally within clinical product teams (CPT) to ensure the clinical strategy is translated into the development of the study concept document, study protocol and related documents
- Develop relationships with appropriate consultants and key external experts (KEE), study sites, and utilize these relationships to obtain feedback on protocol design, as well as study training, study execution, and interpretation of study results.
- Responsible for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation.
- Accountable for the clinical and scientific leadership and integrity of protocols and/or components of clinical plans
- Supports or leads interactions with global medical affairs, marketing companies, commercial, and regulatory functions in collaboration with GCH/GCPL to ensure cross functional input into protocols.
- Contributes to technical review of protocols with governance bodies such as DRC and PRC.
- Contributes to the development of Medical Oversight Plan (MOP), study level safety reviews and study-level medical monitoring activities
- Works closely with Clinical Operations to ensure the timely initiation and delivery of clinical trials
- Responsible for the clinical and scientific input into a study and for the quality of the clinical data
- Contribute to advisory boards to ensure there is engagement with site specific KEEs to ensure robust study designs, recruitment strategies
- Contributes to the review and interpretation of clinical data (HLRs) and the development of content needed for governance committee interactions seeking Go/No Go decisions.
What experience you need to be the successful Medical Scientist:
Essential for the role:
- Bachelor's degree with focus on life sciences or equivalent
- Industry or academic experience in drug development
- Detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.
- General knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals.
- Ability to grow and maintain a high level of expertise in oncology therapeutic area.
- Drug Development/Clinical Development Planning: Demonstrates the ability to undertake the planning, and timely organization of components of the clinical development plan and work with other functions to achieve successful study initiation and execution.
- Ability to drive/contribute to protocol design, writing and implementation
- Demonstrates solid understanding of methodology in the design, conduct, review and interpretation, and presentation of clinical research.
Desirable for the role:
- Either Ph.D. degree in life sciences or MD (preferred)
- Strong preference for Oncology experience
- Emerging leadership skills in individual and team settings to influence others and drive consensus building where needed
- Emerging communication & presentation skills to communicate scientific concepts/data clearly and crisply in team settings and in formal presentations to leadership committees (e.g LSPC, DRC, PRC) or external groups (e.g Investigator Meetings, IDMCs, Conferences Presentations)
This really is a fantastic opportunity for a Medical Scientist to progress their career. If you are interested, please apply as soon as possible as this position will be filled quickly so don't miss out!
Services advertised by Gold Group are those of an Agency and/or an Employment Business.