Experienced Project Manager, Drug Development (CMC/Clinical) – Top $/Will Relo (Remote Option)
Our client, a SC-based pharmaceutical company that specializes in women’s health, is expanding its development team and actively recruiting for a highly capable and mission-driven candidate to build out its Project Management function.
The company is a leading provider of contraceptives in the US, and is fully committed to developing and distributing reliable and affordable reproductive and sexual healthcare to all communities. To date its product portfolio has been driven by key partnerships and alliances. It is now developing its own products and this Project Manager will be instrumental in ensuring success.
Key Things to Note:
- The company currently has 2 products in development – both injectables (ANDA; 505(b)(2)) – with several others under review.
- The PM role will involve facilitating the full cycle of drug development and ensuring that all stakeholders (both internal and external) are operating in unison. Outstanding PM technique must be complemented by extensive knowledge of CMC as well as familiarity with clinical, regulatory, quality, data management and all other aspects of drug development.
- This PM will be responsible for developing a robust cross-functional project plan that will facilitate decision-making, transparency and efficiency across the development team. Seek candidate who brings the expertise needed to design and implement smart and effective Project Management protocols
- This company, which was established in 2008, has a start-up vibe. It has an inclusive and empowered environment in which resourceful, flexible, collaborative, focused employees will thrive. This is a wonderful opportunity for those who bring similar qualities and values.
- This company is in Charleston, SC. There is a preference for candidates who can be on-site full-time (relo provided) but will consider excellent remote candidates who can travel to Charleston regularly.
- Builds and implements formal project management operating guidelines (e.g., process, governance, templates, resource management).
- Continually assesses and improves project planning process, templates, and reporting/analytics practices.
- Partners with team members to manage timelines and spend for assigned projects.
- Conducts quarterly forecast reviews with project leads and Finance business partners to support forecast updates and annual budget build processes.
- Constructs and maintains the project plans to define the timing / schedule and resource requirements (FTEs and external costs) for the activities needed to execute the project.
- Ensures appropriate alignment between the functional plans and the Master Project Plan maintained by the Drug Development Team. This includes proactive monitoring of milestone changes and requires strong partnership and communications with members of the Drug Development Team.
- Produces “what-if” scenario analyses and cost-estimates to reflect alternative development timelines. Also challenges the project team members to think outside the box. Scenario analyses are used to support decisions that impact project delivery, costs, and resource requirements.
- Conducts analytics and reporting to support regular reviews of project level forecasts with project leads and Finance.
- Utilizes data analytics and reporting tools to quantify and explain project level forecasts, changes over time, deltas between scenarios, and inform decisions.
Targeted candidate will offer a related degree and 7+ years of experience in pharmaceutical development, with 4+ years in a project management role. Strong CMC knowledge will be important. PMP certification preferred.
Other priorities include:
- Experience managing project plans, teams, or initiatives, including knowledge and experience with application of a disciplined project management process
- Understanding of FDA regulations and ICH Guidelines regarding drug development phases and clinical research
- Advanced MS Excel, MS Project and Enterprise Project Management capabilities
- Ability to convert datasets into charts, graphs, and slides, with explanation / insights clearly articulated
- Longevity and impact in previous roles
Finally, we seek a collaborative go-getter with the demonstrated ability to garner the respect and cooperation of a large and disparate constituency and help guide them to shared success. Experience in a start-up and/or emerging business setting is preferred. Ability to build a PM program from the ground up, essential.
This is an immediate need. Please forward Word resume for prompt consideration.