Executive Director, Program Strategy, Rare Disease & Pediatrics (home-based in the US)

Premier Research - Nashville, TN3.2

Full-timeEstimated: $120,000 - $170,000 a year
EducationSkills
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, Rare Diseases and Pediatrics, pediatrics, and rare diseases.

We’re looking for a talented and energetic Executive Director of Program Strategy, Rare Diseases and Pediatrics, to join our team!

In this role, you’ll be responsible for providing strategic planning, coordination, knowledge and expertise in a specific subject matter for projects and/or standalone consultative services. You will support the Business Development and Operations efforts for key customers with regard to designing and managing effective clinical trials/programs bringing specific regulatory, medical/scientific and operational knowledge in Rare Diseases and Pediatrics. You will also provide support and input as it relates to the RFP process and offers support to operational teams for strategy, risk assessment and management, study design challenges and overall customer relations.

In this role, you will be accountable to

Serve as the principal strategist who advises, consults, plans and directs the design and strategy of new business opportunities (RFPs) and/or provides consultative services to customers
Ensure smooth and timely input and support to the needs of proposal development, strategy and pricing
Plan as it relates to customer development, strategy and operational input to add value and relevance to the sales cycle
Drive improvement in overall win rate and customer satisfaction
Take the initiative to provide input and improve the proposal strategies information flow between customers and key staff within Premier

You’ll be responsible to:
Lead and/or partner with Operations and Business Development for planning of bid defense meetings or capabilities meetings
Interact with Business Development for all proposal development support related Rare Diseases and Pediatric studies
Develop and improve in the pricing and related strategies that provide the best scenario to meeting project margins on successfully awarded work
Assist with development and improvement of “signature of quality” plans to enhance Premier’s performance and contributions to customer programs
Review RFP’s, assess monitoring strategies and resources to support budget development
Participate in Business Development presentations as appropriate
Serve as liaison with Clinical Trial Management (CTM) colleagues globally to ensure continuity throughout assigned global RFPs and Business Development opportunities
Participate in the recruitment, retention and ongoing professional development of CTM staff when requested
Liaise with other Premier Research departments to ensure the success of all project initiatives related to RFPs and Business Development needs
Assist with improvements to the standard capabilities and selling tools required
Support medical writing team in the development of protocol design as well as CSR review and input as needed
Develop and foster relationship with existing and potential clients
Develop and foster the Premier site relationships and networks aligned with Rare Diseases and Pediatrics
Assist with feasibility assessments and provides input for feasibility questionnaires and may also directly connect with potential sites for assessment of participation, protocol considerations and enrollment projections
Maintain strong knowledge of major events and challenges within the Rare Diseases and Pediatrics area and provide instruction to team members and managers on those issues as well as training
Must be available to perform up to 50-65% of overnight business travel, both domestic and international, as required (additional travel is possible based on project requirements and availability)

You’ll need this to be considered:
Undergraduate degree or its international equivalent in clinical, science or health related field from an accredited institution is required. PhD or MS is strongly preferred.
Minimum of ten (10) years clinical research experience with at least three (3) in a CRO or pharmaceutical environment
Minimum three to five (3-5) years supervisory / management experience including oversight of large groups.
Global clinical trials experience in managing clinical resources
Experience in designing and/or managing clinical trials in Rare Diseases and Pediatrics
Proven people manager with ability to guide staff through major changes, encourage teamwork and develop team capabilities
Experience in public speaking and ability to represent Premier Research at conferences/round tables/symposiums
Strong knowledge of regulatory, scientific, technical and clinical expertise in conduct of clinical trials in the respective area of focus as demonstrated by past positions related to the therapeutic area in the CRO and Pharma/Biotech sector
Extensive knowledge of the commercial and regulatory environments in the area of Rare Diseases and Pediatrics
Excellent verbal and written communications skills with an ability to distill scientific or medical concepts into compelling and differentiating strategies and arguments
Professional and interpersonal skills with the energy, vision and drive a high performance culture
Able to motivate and manage a number of stakeholders and contributors to meet deadlines and to produce a winning service proposal and high quality work