The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, with offices located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India.
The CRO occupies a unique position in the clinical research industry, supporting biotech in clinical trials across all phases (Ph. I - IV) and non-interventional studies, as an expert in the operational delivery of clinical trials. Our vision is to conduct clinical trials better than anyone else, to help patients and ultimately save lives. We have earned a strong reputation for successfully delivering complex, demanding and innovative clinical trials, with specialist therapeutic expertise in oncology, cell & gene therapy, radiopharmaceuticals and rare diseases.
Purpose
Medical Director has accountabilities inclusive of medical and study vigilance activities plus department management responsibility. The include, but are not limited to the following :
- Medical and safety monitoring activities.
- Therapeutic Area Training of Business Development, Project Team and Other Staff
- Support of Business Development Activities
- Department profit & loss management
- Leadership / Line Management
- Vendor identification, qualification and management
- Department process management and continued development
- Strategic planning
- Audits and inspections
- Key performance indicators
- Non-conformities
- Other ad-hoc or permanent roles as assigned
All responsibilities and work performed on behalf of Aixial will follow all applicable local, regional, trial and product specific regulations.
Responsibilities
Medical and Safety Monitoring (as outlined in the scope of work)
Protocol synopsis, Full Protocol, Briefing Document (MHRA), pre-IND, IND application development if applicableReview, contribute to and / or generate :Safety case documentation
Annual safety reportingProject related documentsProvide consultation :Project team and investigative sites for protocol / project / therapeutic inquiries.
Therapeutic areaStudy product trainingProtocol eligibility, acceptable medications, lab alerts, etc.Manage and / or participate in data review or monitoring committeesAccountable for all medical and safety aspects of products in clinical development, including individual case assessment, aggregate reporting, signal detection, risk management throughout the life cycle of the study.Patients monitoring,
Evaluation, interpretation, and appropriate management of safety and / or efficacy data.
Includes initiation, review, and closure of safety queries.Coding review for Concomitant Medications, Medical History, and Adverse Events (AEs) / Serious Adverse Events (SAEs) / AEs of Special Interest.Protocol deviations review.Medical review of tables and listings for trends.Participate in the safety signal detection activities and global literature search for selected studies on the product / program level.Analyze and assess the potential necessity for Protocol AmendmentsAdditional tasks may include attendance and participation at Investigator Meetings, KOMs, Provide oversight of final SAEs / AEs reconciliation between clinical and safety databases.Ensure compliance with :Global regulations including US Code of Federal (CFR) regulations; European Union
EU) Volume 10 clinical trials directive and appropriate ICH guidelinesProject or Programme Oversight
Lead projects teams and serve as point of escalation for customer accounts.Utilize pre-clinical and clinical experience to develop strategies for project or program delivery. This applies from pre-sales through close of project.Works with global functional leaders and external partnerships to support and drive project / programme strategy.Analyze protocol design and partner with stakeholders in developing profitable studies for company, client, and site; Identify critical success factors and preliminary risks.Effectively communicate critical updates and changes within program / projects on a regular basis, acknowledge employee / project successes and address risks to delivery with a focus upon mitigation planning.Review and identify program / project trends and proactively respond to customer and respective team members to drive solution-based discussions and outcomes.Lead and support the development of early risk identification which pose obstacles to the successful delivery of program / project outcomes.Serve as a key contact for assigned programmes / projects / clients.Execute project oversight ensuring adherence to company SOPs, FDA and ICH guidelines, as well as all other applicable regulatory authority requirements and guidelines.Interact with other departments to ensure high quality and execution of deliverables on-time and within budget.Review project budgets, monitoring costs, potential overruns, and implement cost effective solutions.Provide regular project reports and updates to customers, as requested.Use strong communication skills and effective working relationships to ensure consistent quality of work.May function in the role of Project Leader when necessary to support client and business needs.Business Development
Support of Business Development Activities the sales process through end of awarded project.Establish medical and / or vigilance specific trial strategies which includes cross departmental and vendor communications.Strategies will be applied in early engagement discussions, proposals, bid defenses and prospect closing work.You'll engage with clients directly but is not scouting or closing sales deals.Work with sales on communication choreography. Defined sales, proposal, presentation, and interaction strategies and assembled research and resources.Coach medical services sales team through proposal defense. Ensure impactful sales message delivery.Calculate and convey costs, generated ballparks or detailed budgets, and fine-tune bids.Collect and apply lessons learned from wins and losses, both sales and post awardWorking with contracts and proposals service function to develop quality proposals, budgets and review operational specific language in contracts.Global Resourcing and Line Management
Responsible for compensation planning and talent review for direct reports.Proactively participate in the selection and recruitment of suitable and qualified staff.Proactively assess, revise and improve training processes and requirements.Support / conduct performance appraisals; coach and develop staff for further advancement or enhanced skill development.Ensures staff compliance with SOPs / and all applicable trainingEnsures staff compliance with financial processes associated with all project / programme budgets (forecasting, CNF / CO, invoicing etc.)Department Management
Demonstrate great leadership and communicational skillsDepartment profit & loss management including :Cost of Sales planning and management
Team utilization and productivityHeadcount managementProject and / or program revenue and billing,Budget scope management,Change order management.Support recruitment, supervision and development of staff as well as ensure available resources are balanced with contracted obligations and corporate objectives.Establish and maintain strong working relationships with clients, vendors and company staff.Serves as senior leader within Aixial operations matrix structure in support of global organizational needs and assist in the evolution of a global structure as the company grows.Lead or participate in process development and / or improvement initiatives across operational unit and in alignment with the CRO to deliver efficiencies and benefits to customers.Support Aixial's launch of marketing and innovative solutions through the implementation of change management programming to ensure adoption and sales for continued growth.Ensure compliance with regulations and industry quality standards and assurance of audit readiness; includes the development of suitable company SOPs and compliance with FDA, EMEA, country specific and ICH-GCP guidelines and representation during audits and inspections.The Director may lead strategic planning and implementation of process improvement in support of operational excellence aligned with project / program delivery, the medical / study vigilance operations business unit and the CRO enterprise.Uphold the Aixial Manager Code of ConductOther
Other ad-hoc or permanent roles / assignments as requiredRequired skills and qualities
Essential Work Experience, Qualifications and Knowledge :
Medical Doctor : MD or DO MBBS, MBChB or equivalent degree Scientific background and clinical development knowledge, experience, and ability to interpret clinical study safety information.Minimum of 10 years global drug development experience with deep clinical research and operational strategy experience in the Pharmaceutical / Biotech and CRO industriesMinimum of 10 years of managerial experienceKnowledge of ICH GCP guidelines and industry standards of qualityProblem solving capabilities with strong attention to detailRelationship building skills and strong interpersonal presenceDesirable Work Experience, Qualifications and Knowledge :
Medical Registration Licence in UK, EU or USClinical research experience in Oncology, CNS or NeurologyProven management experience within the Pharmaceutical / Biotech and CRO industryAbility to prioritise multiple tasks and follow to completion with industry expertiseStrong motivational skills and understanding of customer serviceTechnical skills
Great presentation skillsDemonstrated experience in relevant therapeutic disciplinesDemonstrated ability and experience in building client partnershipExperience in personnel, financial and operational managementDemonstrated experience in relevant software (e.g. Microsoft Office)Languages
Required : Fluency in spoken and written English
Local specifics
The above job description in no way states or implies these duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company. The Company reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company.
For more information on Aixial Group recruitment and consideration for other opportunities, please review the recruitment statement on our careers page - https : / / www.aixialgroup.com / join-us /
Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by Aixial Group CRO Talent Acquisition. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Aixial may directly contact for employment application.
