Scholar Rock is a clinical-stage biopharmaceutical company focused on creating a robust pipeline of product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, fibrosis and anemia. Our proprietary platform is built upon newly elucidated understanding of the molecular mechanisms of growth factor activation, which has led to the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level.
Our lead product candidate, SRK-015, is a highly specific inhibitor of myostatin activation and is currently being evaluated in a Phase 2 proof-of-concept trial for the treatment of patients with Type 2 and Type 3 Spinal Muscular Atrophy (SMA). SRK-015 has received Orphan Drug Designation in both the US and EU.
We are also advancing SRK-181, a highly specific inhibitor of TGFβ1 activation, into clinical development with plans to initiate a Phase 1 trial in patients with solid tumors in mid-2020. We believe SRK-181 has the potential to treat tumors resistant to checkpoint blockade therapy, such as anti-PD(L)1 antibodies.
Summary of Position:
Here is your opportunity to join a brilliant and experienced team, whose focus is solving some of the most complex problems in growth-factor biology, developing therapeutics that help people with serious illness by using innovative science and cutting edge antibody research. The Director of Program Management will play an instrumental role in the strategic planning and execution of critical programs spanning IND-enabling through all stages of clinical development. This highly cross-functional position requires broad knowledge across all facets of drug development, including: translational sciences, clinical pharmacology, clinical operations, biometrics, pharmacovigilance, CMC, regulatory, and quality assurance. To be successful the person in this role must have command over the strategy and supporting critical path/activities, risks, contingencies and alternatives and proactively manage daily program/project management activities, including schedule development, budget, communication, status reporting, and resource plan development. The ideal candidate has strong communication and influencing skills, ensuring that all team members understand priorities, objectives, deliverables, interdependencies and timelines.
- Partnering with project lead(s) in the creation of integrated development plans, setting program goals and driving towards successful execution of clinical-stage development program(s)
- Lead program management activities, including program operational timeline planning and milestones tracking, meeting management/minutes, accountability of action items and internal presentations and reporting
- Applies project management best practices in the development, initiation, tracking, planning, execution, control and closing of projects
- Builds strong relationships with team members to create an environment of transparent communication, mutual respect, and trust
- Collaborating with finance, function heads and team representatives to develop and manage program budgets, including scenario/long range planning and reporting
- Proactively identifying risk, gaps, and resource bottlenecks; work with teams to develop and implement mitigation and contingency plans for successfully completing program objectives on-time
- Provide hands-on support to cross-functional teams charged with overseeing specific tasks and stages of program development.
- Develops reports and metrics for communicating program status to inform all levels in the organization (Executive, Management, Program Team).
- Helping to shape the program management function and establish best practices at a company that is growing rapidly
- Performs other related duties as required by the position
- 5+ years of experience in program management in life sciences (biotech and/or pharmaceutical) managing cross functional teams in R&D.
- BS in a scientific discipline; Advanced degree and PMP certification preferred
- Experience in rare disease and/or oncology drug development
- Experience in both IND-enabling and clinical stage drug development
- Demonstrated understanding and experience in drug development across all phases of the project lifecycle including initiation, budget planning and execution
- Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal and written communication skills
- Highly organized and able to support multiple projects simultaneously; outcome oriented, self-motivated performer
- Familiarity with ICH guidelines and GCP
- Proficiency MS Project, Word, Power point, Excel
- Ability to adapt to change in a growth environment
- Travel as needed (estimated 10%)