Project Director, Dermatology - Remote
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.
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
At Premier Research, our mission is to improve healthcare by transforming life-changing ideas into new medical treatments that address the unmet needs of a diverse global population. Achieving this is impossible without creating a culture where our employees are given the power to think creatively, challenge ideas, and solve complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we strive to create a community of belongingness where our differences are welcomed and celebrated. It fuels our innovation and better connects us to the patients, physicians, and customers we serve.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.