Director, Strategic Development and Delivery

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.

We are currently looking for an enthusiastic and talented Director, Strategic Development and Delivery. This role is home-based in the US and open to candidates based in the central or eastern time zones.

Purpose

Strategic Development and Delivery provides 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 defenses and prospect closing work. You'll 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. Following project award, the Director, Strategic Development and Delivery is responsible for the oversight of programs, and projects within the Clinical and Regulatory Operations or Full Services project portfolio. Responsible for representing Aixial Clinical and Regulatory Operations externally to current and prospective clients; providing leadership support to business development activities such as participating in capabilities presentations, bid defense 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. The Director may lead strategic planning and implementation of process improvement in support of operational excellence aligned with project/program delivery, the clinical/regulatory operations business unit and the CRO enterprise.

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 profitable studies for company, client, and site; Identify critical success factors and preliminary risks

• Work with sales on communication choreography. Defined sales, proposal, presentation, and interaction strategies and assembled research and resources.

• Coach 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 award

• 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.

• 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 Aixial's launch of 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.

Leadership and Operational Management

• 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.

Project Management

• 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 Manager / Project Leader when necessary to support client and business needs

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 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.

• Line management will depend on level

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 defense practices.

Required skills and qualities

Essential Work Experience, Qualifications and Knowledge:

• Bachelor's or master's degree in life sciences or equivalent industry experience

• Minimum of 10 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

Technical skills

• Demonstrated experience in relevant therapeutic disciplines

• Demonstrated ability and experience in building client partnership

• Experience in personnel, financial and operational management

• Demonstrated experience in relevant software (e.g. Microsoft Office)

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 a Aixial Group HR or Talent Acquisition Manager. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Aixial may directly contact for employment application.