Associate Medical Director - Oncologist
- Experience Level
- Experienced (non-manager)
Our client is a midsize organization specialized in complex Oncology indications with clinical trials running in Phase I-IV. The role of Associate Medical Director is a wonderful opportunity for an experienced Medical Monitor to step into a leadership role participating in all stages of Clinical Development!
- Acts as Medical Monitor for more complex trials.
- Participates in all stages of the Clinical Trial Development process, e.g., feasibility assessments, protocol design, case report form design, investigational site selection, medical monitoring plan development, ongoing medical support, management of AE's and SAE's, and involvement in trial-related meetings.
- Responds to study specific audit queries and supports in the resolution of the audit findings.
- Supports the Medical Director in resolving general department CAPAs, escalations and cascading any audit findings to the study team during monthly department meetings.
- Generation of protocol and synopsis writing with sponsor and Technical Writing team.
- Review Clinical Study report and provides feedback to the Medical and Technical Writing team.
- Generates Medical and Patient narratives and safety update reports.
- Provide therapeutic area support throughout the organisation, including the provision of required internal training and review of study/bid proposals.
- Maintain knowledge of trends and changes of importance in the medical management of indications, regulations and guidelines relevant to the company projects.
- Develops interactions with Key Opinion Leaders and investigators in therapeutic areas of interest to the company as a resource of specific information on indications, patient treatment, and safety assessment for ongoing studies and support business development activities.
- Supports the Pharmacovigilance department in reviewing ICSRs, CIOMS narratives, and periodic safety reports and identifies and communicates emergent safety aspects and trends to the Clinical Project Teams and client.
- Ensures that Clinical Trials conducted by the company meet the relevant regulations and guidelines and are conducted to the highest ethical standards.
- Supports the development of Standard Operating Procedures to drive best practice across the Medical Department.
- Interprets Clinical and Pharmacovigilance data (including the coding of clinical data and the review of relevant safety reports) to identify any potential safety concerns and advise the study team accordingly.
- Supports in business development activities, e,g, proposal requests, feasibility and site contact, and attendance at bid defence meetings.
- Supports the study team in reviewing audit findings that require medical input and communicates to the Head of the Department to apply corrective and preventive actions.
- Support Clinical Development/Senior Clinical Development physician in their assigned studies when required.
- Physician / Medical Degree (MBBS, MD, Doctor of Medicine etc.)
- Experience in medical monitoring, review of patient, laboratory, and safety within a clinical research environment
- Experience in business development activities, including feasibility and strategic advice for proposal development and bid-defence meetings
- Excellent organisation and time management skills. Ability to effectively manage any changes to priorities/deadlines
- Experience in Regulatory and sponsor audit and resolving CAPAs.
- Experience in Pharmacovigilance process, including medical review.
- Professional communication and presentation skills
- Strong computer skills including but not limited to the knowledge of electronic data capturing systems and MS-Office products such as Excel and Word
Permanent / full-time
Homebased anywhere in EU/UK
ABOUT PLANET PHARMA
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.