South San Francisco, CA
$1 - $1
Master of Science
Apr 20, 2017
Operations Program Director (South San Francisco)
The Operations Program Director (OPD) is a strategic leadership role and contributes to the development of the strategic plans for Pharma Development projects. As a member (or leader) of the Global Development Team (GDT), the OPD represents Product Development Global Operations (PDG) and the Study Management Team (SMT) and contributes to development and accountable for the implementation of the CDP. For pRED/gRED projects, the OPD works with the pRED/gRED Clinical Operations colleagues to contribute early strategic input to the CDP.
8 -15 years overall work experience. 6-13 years with Master’s Degree; 3-10 with PhD
BSc or MSc in Scientific, Medical or Healthcare subject required. Further qualification, e.g. PhD or MBA preferred.
Skills & Knowledge
Extensive experience in pharmaceutical industry and drug development experience. Therapeutic area experience a plus. Experience in other business areas provides added value
Demonstrated successful global clinical program management across phases I-IV in pharmaceutical industry
Substantial experience in organization, implementation, and delivery of global clinical programs.
Thorough understanding of all aspects of clinical drug development, proven experience in strategic planning, proven ability to understand and critically assess the global clinical development plans, protocol design, resources needs, global budgets and timelines for programs (in one or several countries).
Demonstrated ability to think strategically and drive development of program strategies with strong decision making and ability to weigh short and long term impact of decisions
Ability to think beyond the home function, identifying connections between different areas of the organization to see the business in a new way
Consistently delivers and adds value above and beyond requirement of OPD
Recognized as expert in therapeutic area and/or leader across organization
Demonstrated leadership, influencing, communication and strategic project management skills at all levels of an organization. Communicates with energy and passion, to engage and inspire others
Demonstrated ability to understand and execute clinical development strategies and mobilize stakeholders. Ability to anticipate and solve complex problems that have impact in multiple areas significant experience in leading teams in a matrix environment.
Ability to maintain relevant knowledge of business, regulatory, and therapeutic advances that may impact life cycle planning or ongoing operational strategies and translate knowledge into influencing strategic direction. Tracks emerging trends and applies these to improve business outcomes
Strong analytical skills, including previous experience with forecasting and analyzing benchmarking research results. Ability to analyze complex activities and information to arrive at logical conclusions, and that meets the overall objectives and long-range plans of an organization.
Demonstrated excellent team and interpersonal skills
Effective communication skills; fluency in verbal and written English, any other language skills may be an asset
Accountable for operational strategic planning, oversight and delivery of all PDG project related activities within the development team and in accordance with the CDP
Accountable for providing oversight, guidance and leadership to all PDG staff assigned to the clinical program in the global matrix environment
Responsibilities primarily strategic: Exercises significant latitude in department approaches and objectives. Operates at strategic level including input into risk management plans, business value assessment and therapeutic area/indication expertise. Planning horizon is 12-24 months.
Directs and is accountable for the success of Product Development projects.
Serves as a primary consultant to senior-level colleagues (GDT Chairs, Life Cycle Team Leaders and GDTLs, GLT), functional leadership and cross-functional stakeholders within and outside of PDG. Provides guidance and mentorship to OPD II and OPD I colleagues on specific activities and approaches to work. Work is performed in partnership with, but without appreciable direction from TA Lead.
Contributes to the development of the life cycle and clinical development plans including scenario planning, high level forecasting of timelines, assessment program level feasibility, estimation of resources and budget, and development of high level operational strategies. Handles unique challenges and decisions that have an impact on function and disease area. Communicates initial budget, timelines, and changes to review bodies as appropriate
Provides disease area input and participates in in-licensing assessments, participates in Due Diligence assignments to represent PDG and provides expertise to early development programs as needed
Provides innovative and flexible operational solutions and options for the CDP
Accountable for meeting all operational deliverables in accordance with the time, cost and quality commitments. Maintains an overview of status, issues, and proactively communicates progress, issues or changes that may impact timelines and costs of the program to all stakeholders. Maintains internal consistency across studies within a program.
Collaborates effectively with internal and external partners; ensures alignment of operational program to the development team’s goals
Provides program leadership to the matrix team of PDG including HQ, affiliate staff and study teams by providing program specific guidance, clinical trial management expertise, operational strategies, and direction to achieve results. Mentors and coaches PDG staff. Provides timely feedback to functional managers regarding staffing needs and individual performance in the program
Actively participate and contribute in PDG governance (i.e. Open Mike, Pre LSPC, TA/DA Forum) and leadership forums including leading critical cross functional initiatives within PDG and PD at large.
Provides direct project expertise and oversight on an ongoing bases to GSLs, GSMs and GSAs
Assigned to more complex programs or more than one program
OPD can be the leader of the Development Sub Team based on leadership skills and competencies. The OPD carries overall accountability for the development and adequate execution of the Clinical Development Plan
Creates an environment supporting innovation and smart risk taking to support, drive and implement novel approaches to drug development