Executive Director, Program Strategy, Rare Disease / Pediatrics (Home-based, US)
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 Rare Disease and Pediatrics, Analgesia, Neuroscience, Oncology, Dermatology, and Medical Devices.
We’re looking for a talented and energetic Executive Director, Program Strategy with Gene Therapy experience to join our Rare Disease and Pediatrics team!
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact in an aspiring, empowering and caring culture where people truly work as one team. You can grow and contribute your expertise with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
As the Executive Director, Program Strategy, you’ll have the opportunity to showcase your strategic and therapeutic expertise to advise, consult, plan and direct the design and strategy of new business opportunities and provide consultative services to customers. You’ll also support the Business Development and Operations efforts for key customers as a Principal Strategist in the design and management of 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 offer support to operational teams for strategy, risk assessment and management, study design challenges and overall customer relations.
What you’ll be doing:
- Strategize with Business Development for all proposal development support related to Rare Diseases and Pediatric studies; lead and partner with Operations and Business Development for planning of bid defense and capability meetings. Liaise with Clinical Trial Management (CTM) colleagues globally to ensure continuity throughout assigned global RFPs and Business Development opportunities
- Review RFP’s, assess monitoring strategies and resources to support budget development
- Develop and improve the pricing and related strategies that provide the best scenario to meeting project margins on successfully awarded work
- Provide leadership to professional staff and managers within the Rare Disease and Pediatrics team
- Ensure compliant and profitable project delivery that meets or exceeds customer and industry standards
- Assist with improvements to the standard capabilities and selling tools required
- Support our Medical Writing Team in the development of protocol design as well as CSR review and provide input
- Develop and foster relationships with existing and potential clients as well as the Premier site relationships and networks aligned with Rare Diseases and Pediatrics
- Assist with feasibility assessments and provide 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
You’ll need this background to be considered:
- Bachelor's degree (PhD or MS strongly preferred) in a clinical, science or health related field along with 10-12 years in Clinical Trials Experience including 5 years in a CRO or pharmaceutical environment.
- Experience in designing and/or managing clinical trials in Rare Diseases and Pediatrics, which includes Gene/Cell Therapy Clinical Research including strong knowledge of regulatory, scientific, technical, and clinical operations; extensive knowledge of the commercial and regulatory environments in the area of Rare Diseases and Pediatrics, including gene/cell therapies.
- 7-10 years in a leadership/coaching position with the ability to guide others through major changes, encourage teamwork and develop team capabilities
- In depth experience in public speaking and presentation delivery
- 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 to succeed in 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
- Must be available to perform up to 50-65% of overnight business travel, both domestic and international.
- Maintain a positive working environment that embodies a culture of aspiration, caring, empowerment and a #oneteam approach