What’s in it for you?
We are seeking a talented and passionate individual who thrives in a dynamic, fast-paced, team-oriented, and collaborative environment to be part of our success. In this role, you will be a member of the sotatercept project team and will be responsible for coordinating two critical sub teams; the BLA/MAA submission sub team, and the life-cycle management sub team. Reporting to the Vice President – Program Management – Pulmonary, you will apply your expertise and understanding of drug development to integrate key functional activities, working closely with individuals from many functions including Medical, Research, CMC, Non-Clinical, Regulatory, Market Development and Legal, managing program timeline, scope, budget and risks to enable Sr. leadership decisions.
What will you be doing?
- In conjunction with Regulatory, developing BLA and MAA submission plans for sotatercept, defining timelines, roles and responsibilities, and tracking submission deliverables to maintain the target filing date
- Working proactively with key functional areas and Regulatory to identify potential issues that could impact the target submission dates, and leading cross-functional discussions to reach consensus around solutions
- Integrating multiple cross-functional activities that are directly related to the BLA/MAA filing process
- Managing the sotatercept life-cycle management project sub-team to define the plans and coordinate efforts for development in new indications and of improved product presentations (planning agendas, scheduling meetings, preparing minutes, and following-up with team members on critical action items)
- Maintaining program-related documentation, including, but not limited to, program plans and timelines, decision logs, risk management, and project goals, ensuring appropriate archiving and access
- Facilitating and supporting project/program delivery through Project Management tools and processes including scope, schedule/timeline, communication, budget/cost and risks
- Fostering strong relationships with team members and functional line managers, supporting project-related communications and issue identification and management
- Facilitating internal decision-making processes and prepare regular updates for senior management
- Supporting the program team in establishing and managing external collaborations (e.g. Advisory Boards, KOL Meetings, etc.)
- Playing a key role as a resource to the Pulmonary Therapeutic Area with regard to share learning, process improvement, and identification of specific area needs
What are we looking for?
- Degree in life sciences, with at least 8 years of relevant professional experience in the biopharmaceutical industry, including at least 5 years in relevant project/program management roles
- Recent experience coordinating BLA/NDA filing
- Solid understanding of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc)
- Prior experience in pulmonary therapeutic area would be a plus
- Applied knowledge of project management tools and processes
- Strong computer skills; skilled at using Word, Excel, PowerPoint, Microsoft Project and Enterprise Resource Planning (ERP) tools
- Strong written and oral communication skills
- Ability to work collaboratively with others across all functions and levels within the organization
- Excellent organizational skills and comfort with multi-tasking in a fast-paced environment
- Communicating Acceleron’s development program goals and accomplishments to the external community, investigators, key opinion leaders and corporate partners
How will you grow with us?
You will be joining a growing and advancing company with an active pipeline and will help drive the pulmonary therapeutic area by collaborating with passionate team members. As a part of a dynamic team, you will have the ability to influence the development of sotatercept, our lead asset in the Pulmonary therapeutic area and quickly build ownership in your role and seek new opportunities for growth as we prepare to take this product through phase 3 and commercialization. If you are looking to be a part of an innovative and fast-paced environment, join our team!
*In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.