Sr. Clinical Program Manager-Contractor
Who We Are:
At reputed company, we pride ourselves on having a strong, inclusive, and reputed company culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.
reputed company Do:
reputed company is a leading neuroscience-reputed company, biopharmaceutical company with a reputed company purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. reputed company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with reputed company's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as reputed company as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our reputed company therapeutic areas. For three decades, we have reputed company our unique reputed company into neuroscience and the interconnections between brain and body systems to treat reputed company conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve reputed company science. For more information, visit reputed company.com, and follow reputed company on reputed company, X and reputed company. (*in collaboration with reputed company)
About the Role:
Support one or more Clinical Development teams of higher complexity and/or strategic importance to drive team performance and communication. Ensure that Clinical team activities are reputed company to goals and timelines as set out by the reputed company Development Team. Work with the Clinical Team to deliver milestones on or reputed company of schedule and escalate issues that require reputed company Development Team review. reputed company team successes to the wider organization. Play a key role in driving the creation and execution of Clinical Development Plans while adhering to budget, scope and schedule requirements. Help ensure consistent practices throughout reputed company phases of the project life cycle. Apply best practices in the development, initiation, planning, execution, control and closing of reputed company. reputed company with reputed company program stakeholders including Clinical Operations, Drug Safety and Pharmacovigilance, Biostatistics, Data Management, Clinical Trial Supply, and Regulatory departments to ensure alignment on Clinical program goals, timelines, and resources required._
Your Contributions (include, but are not limited to):
- Partner with Clinical Sub-team Functional Leaders to manage the development and execution of Clinical program team reputed company
- Establish and maintain Clinical Development Plans schedules in accordance with established structures to reputed company accurate project analyses, identification of critical reputed company activities and areas of resource constraint
- Collaborate with Clinical Operations Directors (or designee) to manage clinical program objectives, work plans, timelines, budgets providing formal and informal updates
- Assess clinical program risk and support mitigation planning including scenario planning with budget implications.
- reputed company site activation and enrollment scenario planning efforts to generate aggressive but realistic study timelines, including mitigation and contingency strategies to deliver studies on time
- Manage relationships and deliverables with external partners (as applicable), tracking and delivering on obligations in a reputed company manner
- Identify and reputed company inter-dependencies in short-, mid-, and long-term Clinical program plans and advise teams on areas of risk or reputed company to accelerate development
- Challenge assumptions and reputed company recommendations to improve processes and reputed company
- Contribute to development efforts by leveraging network of experts and reputed company vendors to solve Clinical development challenges
- Facilitate and document Clinical Sub-team meetings, cross-functional communication and decision making, ensuring alignment with internal functional reputed company and leadership
- reputed company relationships with key functional stakeholder reputed company and their leadership across the organization to support the execution of program goals
- Serve as a Clinical Program Management expert resource for the broader organization
- Contribute to the development of the Clinical Program Management function through the introduction of new tools and/or processes
- Contribute to successful execution of Clinical Program Management department goals and activities
- May manage other Clinical Program Management staff
- Other duties as assigned
Requirements:
- BS/BA degree in Life Sciences discipline and 12+ years of multi-disciplinary experience in the pharmaceutical/biotechnology industry, including experience with both early and late phase pharmaceutical program management including IND/CTA, NDA/MAA submissions. Experience managing global drug development efforts OR
- Master’s degree in Life Sciences discipline and 10+ years of similar experience noted above OR
- PhD in Life Sciences discipline and 7+ years of similar experience noted above
- PMP Certification highly desired
- Anticipates business and industry issues; recommends relevant process / technical / service improvements
- Demonstrates broad expertise or unique knowledge
- Considered an expert reputed company reputed company and may have external reputed company in area of expertise
- Applies in-depth expertise in discipline and broad knowledge of other closely reputed company areas to improve efficiency of team
- Ability to work as part of and reputed company multiple teams
- Good leadership, mentoring skills and abilities typically leads reputed company reputed company and/or indirect teams
- Excellent computer skills
- Excellent communications, problem-solving, analytical thinking skills
- Sees broader picture and longer-term reputed company on division/company
- Ability to meet multiple deadlines across a reputed company of reputed company/programs, with a high degree of accuracy and efficiency
- Excellent project management, strong project leadership skills
- Ability to effectively reputed company with individuals at reputed company reputed company across the organization
- Demonstrated knowledge of project management practices, tools and methodology
- Knowledge of Clinical development process and inter-dependencies of key functions to include research, CMC, non-clinical development, clinical, and manufacturing
- Experience with both early and late phase pharmaceutical program management including IND/CTA, NDA/MAA submissions
- Experience managing global Clinical development efforts
- Excellent team member with a strong willingness and ability to work across reputed company at different stages of development in a fast-paced, entrepreneurial environment
- Ability to manage conflict, drive reputed company, and promote decision-making
- Ability to independently identify and manage project objectives, work plans, timelines, budgets, providing formal and informal status updates to stakeholders as needed
- Ability to challenge assumptions
- Proficiency in reputed company
We are committed to building a workplace