Sr. Clinical Program Manager-Endocrinology
About the role
Support one or more Clinical Development teams for our Obesity programs. 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.
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.
- 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
- Preferred industry experience developing drugs for Obesity (e.g., GLP-1)
- 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 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
- Desired industry experience developing drugs for Obesity (e.g., GLP-1)
Qualifications
- 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.
- 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
- Preferred industry experience developing drugs for Obesity (e.g., GLP-1)
- 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 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
- Desired industry experience developing drugs for Obesity (e.g., GLP-1)
Skills
- 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
- Global Clinical development efforts
- Team management and leadership
- Conflict resolution and consensus building
- Assumption challenging
- Smartsheet proficiency
- Business and industry issue anticipation and improvement recommendation
Benefits
- Annual base salary range: $156,900.00 - $214,000.00
- Target annual bonus: 30% of earned base salary
- Eligibility for equity-based long-term incentive program
- Retirement savings plan with company match
- Paid vacation, holiday, and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental, and vision coverage