Senior Project Director, Dermatology (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 Analgesia, Neuroscience, Oncology, Dermatology, Pediatrics, and Rare Diseases.
We’re looking for a talented and energetic Project Director to join our Dermatology team! This is a very exciting opportunity to join a dynamic and innovative team and grow with a forward-thinking organization that is changing to course of medicine.
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment 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 Project Director, you’ll have the opportunity to showcase your expertise as the senior liaison with overall responsibility for your customers and be the primary point of contact for clinical programs.
You will be able to oversee and direct multiple clinical trials concurrently, leading global cross-functional teams and partner with clients in order to set and meet expectations to achieve client satisfaction. In this role, you’ll be asked to proactively identify, mitigate risks or issues. Lastly, you’ll oversee Senior Project Managers, Project Managers and Associate Project Managers assigned to your clinical program.
What you’ll be doing:
- Ensure successful management and coordination of efforts the global project team, including Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall program delivery; monitor the quality of program deliverables
- Ensure program tasks are completed in accordance with program plans and SOPs
- Facilitate, maintain and ensure effective communication and program status reports and monthly progress reports are provided to other key stakeholders
- Ensure adherence to program budget and scope of work to realize program profitability
- Act as the key relationship manager between Premier Research and the customer and monitor/manage customer satisfaction; assist in the creation, development and nurturing of key strategic customer relationships
- Motivate, train and develop the team's expertise to ensure efficient and effective day-to-day operations; supervise and assess the performance of the core team members; facilitate team training, including therapeutic, protocol specific, and process training
- Evaluate program progress based on company tracking systems, program timelines and budget reviews provided by Project Management staff
- Prepare forecasts for staff utilization over the life of the program and continually review and make recommendations to ensure adequate resources are available to meet program deliverables; ensure appropriate transition planning and stakeholder communication for any changes in staff
- Review study audit findings and provide support in generating audit responses as well as corrective and preventative actions
- Support program team in identifying scope of work changes to secure Change Orders
- Assist in Business Development activities including proposal development, proposal costing and budget reviews, and leading proposal presentations in partnership with Business Development and Scientific Account Leadership
You’ll need this to be considered:
- Undergraduate degree, preferably in a clinical, biological or science-related field along with 8 years relevant experience, preferably in a pharmaceutical company/medical device company/CRO including trial management experience; 4 years’ experience in clinical trial management as a Senior Project Manager, managing complex global trials in multiple phases
- Budget/finance/costing experience on a project level
- Experience in coaching/mentoring other PMs
- Excellent knowledge of ICH/GCP regulations and FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
- Highly confident and effective presenter
- Strong software and computer skills, including MS Office applications and web based communication tools for conferences
- Known for strong analytical skills and financial acumen
- Known for being customer-focused in approach to work and communications with the ability to professionally interact with sites, clients, vendors and other functional areas; strong verbal and written communication and negotiation skills
- Maintain a positive working environment that embodies a culture of aspiration, caring, empowerment and a #oneteam approach
- Excellent organizational and time-management skills, able prioritize work to meet deadlines; ability to multitask and work effectively in a fast-paced environment with changing priorities; accountable, dependable and strong commitment.