• Taking on role of Sub-investigator on Phase II and III clinical trials.
• Working with Study Coordinators to deliver timely, efficient and high-quality clinical trial data.
• Conducting patient visits in strict adherence to study protocols.
• Performing duties of a clinical investigator according to the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP), and ensuring the highest standard of care for patients.
• Performing the following clinical procedures (non-exhaustive) as part of the conducting of clinical trials
• Completing Source Documents and Case Report Forms
• Assisting with the dosing of study medication
• Ensuring patient Informed Consent is obtained in line with study protocols
• Assessing and analysing clinical data such as BP, ECG's, laboratory tests, and adverse events according to study protocols
• Performing pre-study medical histories and medical examinations as per SPCR’s SOPs.
• Providing medical cover for trial patients outside of working hours, as arranged in advance.

Skills on Resume:

Trial Management, Protocol Compliance, GCP Adherence, Clinical Proficiency, Data Reporting, Patient Safety, Medication Dosing, Medical Assessments

• Obtain informed consent from subjects prior to inclusion into a study.
• Perform medical screening on healthy volunteers and patients including medical history taking, physical examination and review of laboratory reports according to the study protocols.
• Collate necessary medical documents and information to make informed decisions about inclusion onto a clinical trial.
• Review all Case Report Forms with regard to inclusion/exclusion of subjects prior to commencement of the study.
• Be familiar with all current study protocols.
• Discuss protocols in-house and with sponsors and experts.
• Supervise all safety aspects during the studies.
• Maintain knowledge, understanding and practice of general medical practice and to maintain Advanced Life Support skills.
• Evaluate and treat all Adverse Events that arise during studies and prepare safety reports.
• Produce and update case reports for volunteers who experience Serious Adverse Events or other notable Adverse Events.

Skills: Informed Consent, Medical Screening, Document Collation, Protocol Review, Protocol Familiarity, Safety Supervision, Adverse Event Management, Case Reporting

• Review and analyse safety, pharmacokinetic and pharmacodynamic data and present the findings in interim reports.
• Participate in the discussions regarding the impact data in interim/safety reports has on clinical trial progression.
• Contribute to the writing of Study Operations Manuals for upcoming studies and update as appropriate during the conduct of ongoing studies.
• Write Patient Information Leaflets/Informed Consent Forms for planned clinical studies.
• Review study protocols and to participate in the generation of study protocols as required.
• Write relevant sections of Patient Information Leaflets/Informed Consent Forms. 
• Review and contribute to the development of Investigator’s Brochures when required.
• Review and implement recommendation from scientific advisory meetings into relevant study documents in preparation for submission.
• Participate in discussions with scientific and other experts in preparation for regulatory submissions.

Skills: Data Analysis, Report Writing, Manual Development, Leaflet Authoring, Protocol Development, Document Review, Brochure Contribution, Regulatory Discussions

• Lead the generation of clinical development strategy and plan ensuring medical/ scientific quality and successful registration.
• Be responsible for clinical study design and drafting clinical study protocol, be accountable for all clinical section of documents and trial deliverables (e.g. Briefing documents, Safety Updates, CSR and submission summary).
• Lead clinical trial data review and generate clinical queries, quality control and data validation for clinical study reports, publications and internal/external presentations.
• Oversee and manage the interactions with external experts, collaborators, alliance partners on clinical matters to ensure the timely execution of the Clinical Development Plan.
• Establish and maintain liaisons with KOLs & investigators, organize/provide product relevant training to HCPs when applicable.
• Maintain an up-to-date repository of clinical information in the therapeutic area and share with internal teams timely.  
• Support clinical study site and CRO selection in trial conduct and clinical trial outsourcing process.
• Provide clinical input for commercial assessment and portfolio prioritization. 
• Contribute to the safety management and risk mitigation strategy.

Skills: Clinical Strategy, Study Design, Data Validation, External Collaboration, KOL Liaison, Information Management, CRO Selection, Safety Strategy

• Provide disease expertise to therapeutic area and work out tailored development strategy from end to end
• Lead and drive the molecule development plan, transform strategy into execution plan
• Provide clinical/scientific input and support as medical monitor in trials, e.g. site visit, training CRA on study design
• Act as speaker in investigator meetings, support ethics approvals, data review, regulatory filings preparation, support to inspection from local side
• Assess and drive new indication approval
• Author for clinical document of data for CTN and MAA filing and publication, interpret clinical trial data and participate healthy authority interaction
• Lead peer to peer discussion in consultation with KOLs/Medical Advisory Boards Meetings/Expert Panels.
• Perform studies in accordance with ICH GCP guidelines
• Signing Investigator Agreements to confirm acceptance and willingness to comply with study protocols
• Maintain study records and investigation into any adverse effects and changes to medications
• Assist in pre-screening and recruitment of participants into the studies
• Carry out any specific administrative duties required for individual studies

Skills: Disease Expertise, Molecule Development, Trial Monitoring, Regulatory Support, Indication Approval, Clinical Authorship, KOL Engagement, Study Compliance

• Lead the generation of clinical development strategy and plan to ensure medical/ scientific quality and successful registration. 
• Be responsible for clinical study design and drafting clinical study protocol, be accountable for all clinical sections of documents and trial deliverables (e.g. Briefing documents, Safety Updates, CSR and submission summary). 
• Lead clinical trial data review and generate clinical queries, quality control and data validation for clinical study reports, publications and internal/external presentations. 
• Oversee and manage the interactions with external experts, collaborators, alliance partners on clinical matters to ensure the timely execution of the Clinical Development Plan. 
• Establish and maintain liaisons with KOLs & investigators, organize/provide product-relevant training to HCPs when applicable. 
• Maintain an up-to-date repository of clinical information in the therapeutic area and share it with internal teams timely. 
• Support clinical study site and CRO selection in trial conduct and clinical trial outsourcing process. 
• Provide clinical input for commercial assessment and portfolio prioritization. 
• Contribute to the safety management and risk mitigation strategy.

Skills: Clinical Strategy, Study Design, Data Validation, External Collaboration, KOL Liaison, Information Management, CRO Selection, Safety Strategy

• Design and/or review of the clinical study protocol outline and support the clinical development plan
• Participate in the preparation and/or medical review of clinical documentation related to new or ongoing clinical studies
• Support the clinical research team and provide the medical oversight of the clinical study
• Supervise the safety aspects within clinical studies, working closely with the Pharmacovigilance team
• Collaborate in various scientific publications and meetings related to clinical development
• Analyze study documentation and data in the preparation of clinical study reports
• Ensure coordination of the interaction with investigators, KOL’s, external consultants, and other relevant medical entities in relation to clinical studies
• Manage the medical queries from within the organization and respond to external communications from authorities
• Comply with GCP and SOPs
• Guide the studies to comply with the Quality, Environment, Health and Safety Policies and Standards and Procedures

Skills: Protocol Design, Clinical Documentation, Medical Oversight, Safety Supervision, Scientific Collaboration, Data Analysis, Stakeholder Coordination, Regulatory Compliance

• Board certified in Internal medicine OR pediatrics specialty
• Must have completed education and training at a medical school that meets the requirements of the Saudi Commission for Health Specialties (SCFHS) or equivalent
• or have completed the comparable level of post-medical school clinical training relevant to the country of hiring
• Knowledge of drug development process 
• Demonstrated ability to balance scientific priorities with business priorities
• Demonstrated strong communication, interpersonal, teamwork, organizational and negotiation skills.
• Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
• Fluent in English and Arabic, verbal and written communication.
• Saudi National Physicians, as a government requirement
• Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.

Qualifications: BS in Biomedical Sciences with 5 years of Experience

• Completed their early Specialty or General Practice training (Postgraduate Membership of a Royal College is desirable) and have relevant acute medicine experience.
• Demonstrate equivalent qualifications and experience of clinical practice in acute care of patients.
• Experience in clinical pharmacology in early phase I/II studies, commercial or academic is desirable.
• A relevant post-graduate qualification in clinical pharmacology or pharmaceutical medicine is desirable.
• Commitment to train toward and/or the Advanced Life Support Provider
• Strong verbal and written communication skills
• Excellent interpersonal skills and energy to operate in a complex organisation environment
• Ability to maintain and develop relationships and networks with different communities

Qualifications: BS in Pharmacology with 4 years of Experience

• Clinical experience and preferably post-graduate degree in the field of oncology/haematology or related biomedical field.
• Significant training/experience in clinical development in the pharmaceutical industry or equivalence
• Track record of scientific achievements in clinical research
• Advanced Medical/scientific and state-of the art clinical research knowledge in oncology/hematology
• Familiar with all aspects of the drug development process
• Expert in clinical trial design.
• Proven ability to interpret, discuss and represent efficacy and safety data in the oncology/hematology field.
• Advanced medical/scientific writing skills
• Superior English writing, reading, speaking and listening skills and attention to detail
• Strong communication skills within a multidisciplinary team and in interfaces with other departments and headquarters
• Strong Sense of responsibility and dedication
• Skillful at Word/Excel/Access/PowerPoint/Microsoft project.

Qualifications: BS in Biochemistry with 7 years of Experience

• Prior experience in pharmaceutical industry in commercial and/or Medical Affairs
• Effective communicator (written and presentation) with good interpersonal relationship skills and experience of developing and delivering presentations
• Must excel at working independently and in cross-functional teams
• Analytical and problem solving skills are necessary.
• Relevant Clinical Research & Development experience
• Knowledge of and strict adherence to GCP/ICH guidelines and internal SOPs in Clinical Research and Development
• Previous experience in a Leadership and/or Supervisory role
• Microsoft Office/Suite proficient (Excel, Outlook, PowerPoint, Word, etc.)
• Great interpersonal skills and strong attention to detail
• Excellent communication skills (written and verbal)

Qualifications: BA in Public Health with 3 years of Experience

• Medical doctor, ideally with board certification in internal medicine
• Several years of clinical experience in the area of internal medicine
• Experience in the regulatory area of pharmaceutical products is preferable
• Strong interpersonal, intercultural, and presentation skills
• High ability to solve problems and to structure and simplify complex tasks
• Excellent communication skills for scientific discussions and training
• Ability to work within a global team framework and a multicultural environment 
• Ability to support change in complex organizations
• Fluent in English, both written and spoken
• Familiarity with concepts of clinical research and clinical trial design, including biostatistics
• Knowledge of Good Clinical Practices (GCP), FDA, EMEA/CHMP and NMPA regulations and guidelines, and applicable international regulatory requirements

Qualifications: BA in Health Sciences with 2 years of Experience

• Significant clinical training and/or scientific research background, pharmaceutical industry experience in Clinical Development or Medical Affairs function preferred.
• Strong knowledge and understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules.
• Good written and oral communication skills in both Chinese and English in the negotiation, presentation, and authoring process.
• Scientific curiosity and ability to produce professional work products with attention to timelines, results, and quality.
• Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
• Clinical practice experiences, autoimmune disease/ophthalmology is preferred but not limited
• Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical), experience in autoimmune disease/ophthalmology
• Experience with clinical study management and conduct
• Experience with scientific expert interactions
• Fluency in English, both oral and written communications

Qualifications: BS in Clinical Research with 5 years of Experience

• Significant experience in clinical or academic research preferably in the gastrointestinal, vascular, or neurological field
• Sound knowledge of drug development and clinical trial process
• Strong knowledge of regulatory requirements / International Council of Harmonisation (ICH) guidelines
• Fluent English (oral and written).
• Prior Clinical Research experience in a similar setting
• Qualified to be a Principle Investigator on studies
• Early phase clinical trial experience is preferred but not essential
• GMC Registered Medical Doctor

Qualifications: BS in Biostatistics with 4 years of Experience