Clinical Research Physician
ABOUT THE POSITION
This is a unique opportunity to be a major contributor to the success of a dynamic and late stage biotechnology company.
The CRP will have medical and clinical development responsibility in the ongoing phase III. He/she will ensure an appropriate and continuous medical risk/benefit assessment and will execute a risk minimisation at all stages to secure a sound and ethical development of a safe drug product.
He/she will contribute to establish collaborative relationships with the investigators to ensure an efficient and timely execution of the program. As a speaking partner he/she will provide information about Arfolitixorin through visits to the clinics and virtual meetings.
The CRP will provide medical and clinical development input into clinical programmes from the clinical/scientific and strategic prospective. He/she is also responsible for input to clinical key documents such as CDP’s, IB’s, protocols, reports and clinical parts of key TPPs and IMPDs. The CRP will provide his/ her expertise in the evaluation of data generated in the clinical trials and will also contribute to the company PR and Communication strategy. The CRP will also interact with KOLs and PIs globally and be involved in working with advisory boards.
- Provide strategic input for innovative clinical development plans, incorporating the current therapeutic area landscape
- Orchestrate and manage clinical aspects of regulatory strategies and interactions with Health Authorities
- Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results
- Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders including investigator and clinical advisory boards
- Provide clinical support and work with other members of the management team to develop and communicate the overall corporate strategy
- Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.
Key responsibilities and parameters of the job include:
- Will ensure an appropriate and continuous medical risk/benefit assessment.
- Will execute a risk minimisation at all stages to secure a sound and ethical development of a safe drug product.
- Will ensure medical and clinical development input into clinical programmes from a clinical/scientific and strategic perspective.
- Will contribute to and review clinical documents (e.g CDP’s, IB’s, protocols, reports and clinical parts of TTP’s and IMPD’s).
- Will identify and coordinate contacts with external consultants and key opinion leaders.
- Will support and contribute to overall project deliverables.
- Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (for example, annual reports) according to the agreed upon project timeline, including required document reviews in support of select externally sponsored clinical development oncology trials.
- Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions).
- Review and approve risk profiles to ensure to ensure appropriate communication of risk to study subjects.
- Participate in investigator identification and selection, in conjunction with clinical teams.
- Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
- Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
- Serve as resource to clinical operations personnel / clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
- Understand and actively address the scientific information needs of all investigators and personnel.
- Review IIT proposals and publications, as requested by CMO.
-We are primarily looking for a medical doctor, oncologist, with a strong background in clinical operations.
-Medical Doctor / Physician with a PhD.
-Experience from the pharmaceutical industry, involved in clinical trials from a HQ perspective or locally as medical advisor
-Excellent skills in English, orally and written
Preferred (but not must)
-Medical expertise in oncology
-Proven track record of working in start-ups or in small biotech companies or from head quarters, not only big pharma
-Experience in clinical phases of drug development from early phases to commercialisation
-Self going, creative and solution oriented person
-Open to work in an entrepreneurial and growing organization, where ownership, collaboration and own drive is of greatest importance
-Hands-on approach as well as strategic capability
-Ability and willingness to international travelling
-Humble and a team player
To apply, please send your CV and a cover letter asap to Daniel Kremer at; email@example.com If you have questions regarding this open position, please contact Daniel at +46 (0)733 87 27 24.
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Isofol Medical AB (publ) is a biotech company developing a new drug candidate, the cancer drug arfolitixorin, which is intended primarily for the treatment of colorectal cancer (CRC). It is the third most common form of cancer, and is in great need of more effective drugs. In the treatment of colorectal cancer, arfolitixorin is given in combination with the cytotoxin 5-FU (Fluorouracil) to increase tumour shrinkage and extend the life of the cancer patient. Arfolitixorin consists of the active substance MTHF ([6R]-5, 10-methylenetetrahydrofolate).
The folate-based prodrugs leucovorin and levoleucovorin are currently used in combination with 5-FU in the treatment of colorectal cancer. Isofol intends to replace these with arfolitixorin, with the primary goal of improving treatment outcomes for more than 370,000 colorectal cancer patients in the USA, Europe and Japan. Unlike leucovorin and levoleucovorin, which must be converted to MTHF in the body to be effective in cancer treatment, arfolitixorin consists of the active substance MTHF, meaning that no conversion is required. Therefore, arfolitixorin has the potential to provide a stronger antitumoral effect in all patients in combination with 5-FU therapy.
Through a global licensing agreement with Merck KGaA, Germany, Isofol has the exclusive right to develop and commercialise arfolitixorin in the oncology sector. The license agreement also affords Isofol access to the unique patent-protected manufacturing process for MTHF/arfolitixorin.
Isofol’s operations are based in Gothenburg and the company’s share is traded on the NASDAQ First North Premier exchange.