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 aligned to goals and timelines as set out by the Core Development Team. Work with the Clinical Team to deliver milestones on or ahead of schedule and escalate issues that require Core Development Team review. Highlight team successes to the wider organization. Play a key role in driving the creation and execution of integrated Clinical Development Plans (iCDPs) while adhering to budget, scope and schedule requirements. Help ensure consistent practices throughout all phases of the project life cycle. Apply best practices in the development, initiation, planning, execution, control and closing of projects. Interact with all 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.

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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 strategy

• Establish and maintain iCDP schedules in accordance with established structures to enable accurate project analyses, identification of critical path activities and areas of resource constraint

• Assess program risk and support mitigation planning and tracking

• Independently identify and manage Clinical program objectives, work plans, timelines, budgets, providing formal and informal status updates to stakeholders as needed

• Lead 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 timely manner

• Identify and leverage inter-dependencies in short-, mid-, and long-term Clinical program plans and advise teams on areas of risk or possibilities to accelerate development

• Challenge assumptions and provide recommendations to improve processes and outcomes

• Contribute to development efforts by leveraging network of experts and experienced vendors to solve Clinical development challenges

• Facilitate and document Clinical Sub-team meetings, cross-functional communication and decision making, ensuring alignment with internal functional groups and leadership

• Develop relationships with key functional stakeholder groups 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 8+ 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 6+ years of similar experience noted above OR

• PhD in Life Sciences discipline AND 4+ years of similar experience noted above OR

• PMP Certification highly desired

• 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 projects at different stages of development in a fast-paced, entrepreneurial environment

• Ability to manage conflict, drive consensus, 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 Smartsheet

• Anticipates business and industry issues; recommends relevant process / technical / service improvements

• Demonstrates broad expertise or unique knowledge

• Considered an expert within the company and may have external presence in area of expertise

• Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team

• Ability to work as part of and lead multiple teams

• Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams

• Excellent computer skills

• Excellent communications, problem-solving, analytical thinking skills

• Sees broader picture and longer-term impact on division/company

• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

• Excellent project management, strong project leadership skills

• Ability to effectively interact with individuals at all levels across the organization

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The annual base salary we reasonably expect to pay is $156,900.00-$214,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.