Location: Greensboro,North Carolina,United States
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.
Core Accountabilities:
The Director, Strategy Development and Delivery is responsible for representing the CRO externally to current and prospective clients.
Utilizes clinical and therapeutic expertise during pre-sales and sales engagements. This position will work to establish trial strategies which includes cross departmental and vendor communications. Strategies will be applied in early engagement discussions, proposals, bid defences and prospect closing work. The Director is expected to engage with clients directly but is not scouting or closing sales deals. Client interactions are meant to gather meaningful intelligence regarding future projects and prospects by nurturing ongoing client relationships.
Providing leadership support to business development activities such as participating in capabilities presentations, bid defence meetings, and working with contracts and proposals service function to develop quality proposals. Support recruitment, supervision and development of staff as well as ensure available resources are balanced with contracted obligations and corporate objectives.
Following project award, the Director is responsible for the oversight of programmes, and projects within the Clinical and Regulatory Operations or Full Services project portfolio.
The Director may lead strategic planning and implementation of process improvement in support of operational excellence aligned with project/programme delivery, the clinical/regulatory operations business unit and the CRO enterprise.
Principal Responsibilities:
Strategic
- Utilize pre-clinical and clinical experience to develop strategies for clients from pre-clinical to early phase clinical trials.
- Works with global functional leaders and external partnerships to support and drive project/programme strategy.
- Analyze protocol design and partner with stakeholders in developing successful and responsible studies for company, client, and site; identify critical success factors and preliminary operational risks
- Work with sales on communication choreography. Define sales, proposal, presentation, and interaction strategies and assemble research and resources.
- Apply operational acumen to mentor sales opportunity team from pre-sales through proposal and defence. Ensure impactful sales message delivery.
- Calculate and convey costs; generate ballparks or detailed budgets, and fine-tune bids.
- Collect and apply lessons learned from wins and losses, both sales and post award.
- Serve as senior leader within CRO operations matrix structure in support of global organizational needs and assist in the evolution of a global structure as the company grows.
- May lead or participate in process improvement initiatives across operational unit and in alignment with the CRO to deliver efficiencies and benefits to customers.
- Support CRO's launch of innovative solutions through the implementation of change management programming to ensure adoption and sales for continued growth.
- Ensure trial strategies align with compliance to relevant regulations and industry quality standards; may include development of suitable company SOPs to ensure compliance with FDA, EMEA, country specific and ICH-GCP guidelines.
- Based on seniority of role and department need-Effectively manage sales/business development tasks/deliverables/workload across Clinical and Regulatory team and/or full-service projects who provide sales effort support.
Leadership and Operational Management
- Effectively communicate critical updates and changes within programme/projects on a regular basis, acknowledge employee/project successes and address internal and external operational risks to delivery with a focus upon mitigation planning.
- Review and identify programme/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 programme/project outcomes.
Project Management
- Serve as a key contact for assigned programmes/projects/clients.
- Execute project oversight ensuring adherence to company SOPs, FDA and ICH guidelines
- Interact with other departments to ensure high quality and execution of deliverables on-time and within budget.
- Review project budgets, superintend 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.
Global Resourcing and Line Management (Line management responsibility will depend on level)
- Communicate resourcing impacts of potential projects/programmes to Clinical Operations leadership team
- 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 to meet changing needs.
- Support/conduct performance appraisals; coach and develop staff for further advancement or enhanced skill development.
- Provide guidance and mentoring to direct reports.
Customer Partnerships and Delivery
- Establish and maintain strong working relationships with clients, vendors and company staff.
- Serve as point of escalation for customer accounts.
- Take a lead in the business development of clinical and regulatory services through proposal writing, strategy alignment and coaching staff in bid defence practices.
Additional
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.
Essential Work Experience, Qualifications and Knowledge:
- Bachelor's or master’s degree in life sciences or equivalent industry experience
- Minimum of 15 years global drug development experience with deep clinical research and operational strategy experience in the Pharmaceutical/Biotech and CRO industries.
- Knowledge of ICH GCP guidelines and industry standards of quality
- Problem solving capabilities with strong attention to detail
- Relationship building skills and strong interpersonal presence
Desirable Work Experience, Qualifications and Knowledge:
- Clinical research experience in numerous therapeutic areas
- Proven project management experience within the Pharmaceutical/Biotech and CRO
- industry
- Ability to prioritise multiple tasks and follow to completion with industry expertise
- Strong motivational skills and understanding of customer service
Aixial Core Values and Guiding Principles:
All Aixial employees are required to exhibit and demonstrate the Aixial ‘Core Values’.
- Client focus: Satisfaction and Solutions
- Dependability: Competence and Quality
- Trustworthy: Open and Honest
- Innovative: Approaches
- Winners: Win-Win
All Aixial employees are required to follow Aixial’s Guiding Principles:
- We care about our customers, but are not afraid to say no or disagree
- We only take on projects within our abilities to perform well
- We always aim to do the right thing and approach every situation with good intentions
- We pursue responsible profit and responsible growth, and spend money sensibly, as if our own
- We believe organisation, management, governance and control are positive, but bureaucracy and micro-management are negative
- We love common sense
- We are the enemy of mediocrity
- We have a hunger for innovation and a thirst for ideas
- We show integrity and deal with mistakes
- We acknowledge and value the contribution of others
- We always strive to build an atmosphere that is positive, professional and fun
- We are one Aixial Team
Attributes Include:
Planning and Organisational Skills:
- Good interpersonal and communication skills and the ability to operate effectively in a global working environment
- Good organizational/time management skills
- The ability to work calmly under pressure and meet agreed deadlines
- Ability to work independently
- A transparent, precise approach
- Team player
- The ability to work effectively and efficiently with internal partners
Communication and Teamwork:
- Excellent written and verbal communication skills
- The ability to make effective presentations
- Demonstrated ability to manage and lead teams
- Demonstrated ability to mobilize and motivate teams to ensure delivery in excellence
People Leadership:
- Demonstrated ability to manage staff, providing guidance and overall professional development
- An ability to delegate tasks appropriately
- Approaches work with a professional, positive, and enthusiastic attitude
Technical
- Demonstrated experience in relevant therapeutic disciplines
- Demonstrated ability and experience in building client partnership
- Experience in personnel, financial and operational management
Other
- Domestic and international travel as required
- Transparent approach, clear and precise
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.
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