Director, Program Management (CMC)

Description

SUMMARY:

As a Director, Program Management, you will manage development projects varying in size and complexity, drive the execution of CMC deliverables, and develop and manage budgets/timelines for potential new projects by collaborating with Leadership and experts. You will lead dynamic, cross-functional teams to ensure manufacturing aligns with goals, scope, budget, and risks. Your tasks include building project schedules, establishing strong internal and external partnerships, leading risk management, facilitating meetings and decision-making, organizing documents, and integrating team efforts across programs. You will apply project management best practices in a fast-paced environment and seek continuous process improvements.

Essential Duties And Responsibilities

The main responsibilities of this role include but are not limited to the following:

• Provides program management leadership, support, and facilitation for dynamic, cross-functional CMC Teams.
• Builds and monitors fully integrated project schedules capturing all manufacturing activities and resources needed in accordance with corporate goals, scope, budget, and risks.
• Establishes strong partnerships with internal and external team members to build high-performing teams that will achieve ambitious goals.
• Leads risk management of CMC programs, proactively identifying risks, developing strategies to address them appropriately, and driving the teams to overcome issues and challenges.
• Facilitates internal and partner/CDMO CMC meetings, including scheduling, developing agendas, writing and distributing meeting summaries, and tracking goals and action items to completion.
• Drives teams to effective decision-making and risk/opportunity scenario planning.
• Develops and manage CMC programs budgets in coordination with CMC leads and SMEs.
• Creates, organizes and maintains CMC documents for access by the project teams and coordinate timely CMC document review/approval to support development, manufacturing, Regulatory and Quality activities.
• Works effectively in a fast-paced, matrix environment to integrate CMC team efforts across multiple programs.
• Applies Project Management Best Practices and demonstrate a continuous improvement mindset: proactively seek out, recommend, and implement process improvements.
• Implements new processes and process improvement initiatives designed to improve the efficiency and effectiveness of the Program Management function.
• Other duties as needed.
  
  

Requirements

EDUCATION AND EXPERIENCE

• BA/BS degree required, preferably in a scientific discipline
• 4+ years of experience in a biotechnology or pharmaceutical company required
• 2+ years of relevant, progressive, and cross-functional project management experience required
• Experience in a regulated industry is required
• Typically requires a current PMP certification
• Experience and/or exposure to pharmaceutical product development including IND application and NDA submissions preferred
• Familiar with Pharmaceutical development lifecycles and regulatory requirements
• At least 5 years of cGMP manufacturing program/project management experience in the pharmaceutical or biopharmaceutical industry, with additional CMC technical experience preferred.
• Strong mix of Early and Late Phase Development experience preferred with NDA submission experience a plus
  
  

Knowledge And Skills

• Demonstrated leadership skills with the breadth of professional experience and the drive to work with both internal and external partners to define and implement effective project management plans.
• Strong understanding of drug development, including in-depth knowledge of CMC functions and the strategic and operational requirements from IND to commercial launch.
• Highly skilled at working collaboratively with cross-functional teams and contractors to drive results and meet company objectives, including ability to influence in a matrix organization.
• Proven ability to manage competing priorities, budgets, and timelines in a fast-paced, rapid-growth environment.
• Knowledgeable in cGMP manufacturing and CMC regulatory requirements for pharmaceuticals.
• Self-directed and proactive with ability to function independently, exercise good judgment and respond quickly and effectively to changing environments.
• Technical proficiency with project management tools; strong computer skills and experience with software such as MS Project, SmartSheet, Excel and SharePoint.
• Strong interpersonal, written, and verbal communication skills, with the ability to distill and effectively communicate key messages from complex discussions.
• Exceptional organizational skills and attention to detail.
• Project management skills, along with problem solving, negotiation skills, conflict resolution, influencing skills, and team building skills.
• A background in sterile injectables.
  
  

VIKING THERAPEUTICS

Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Notice to Agency and Search Firm Representatives

Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.