Senior Director of Operations, Asset Operations Lead

Location
Cambridge, MA, United States
Posted
Jul 30, 2021
Ref
R-08345
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Senior Director of Operations, Asset Operations Lead

Company:
Ipsen Bioscience, Inc.

Job Description:

Are you an R&D Operations Leader who enjoys driving cross functional teams during early development of assets?

The main mission of the Senior Director of Operations, Asset Operations Lead (AOL) is to implement the early development asset roadmap by driving the cross functional asset team and to be the right hand to the Research Project Lead up to the Go to Phase I. The AOL is responsible for the implementation of the early discovery and pre-clinical development asset strategy, tactics and plans endorsed by the governance bodies to ensure the delivery of required packages to move forward through the different stage-gates: Lead Identification, Lead Optimization, Candidate Validation and Preclinical upon early development asset status. As AOL you will ensure that all steps of the development plan are anticipated, planned, coordinated and followed-up to result in the most efficient process. The AOL monitors and tracks expenditure against budgets and supports resource management against agreed strategic objectives for the program. The AOL is responsible for ensuring coherent and consistent communication between project functions and for ensuring key issues are reported to the executives in due time and to work with senior team members on issue resolution. When required by the asset team structure, the AOL will be supported by Global Project Managers.

Your role will involve:

Program Leadership
  • Work in partnership with the Research Project Lead, Heads of Function (such as REED and Pharm Dev) and potential partners to develop and implement overall early research & development asset strategy to deliver robust scientific package to move forward through the different stage-gates: Lead Identification, Lead Optimization, Candidate Validation and Preclinical
  • Serves as the central operational point of contact for early asset team members
  • Create a climate that fosters personal investment and excellence and nurtures commitment to common goals
  • Facilitate the process for evaluation of alternative development options to deliver programs
  • Facilitate win/win solutions for program/team conflicts with big picture in mind. Promote ideas persuasively and build on the ideas of others


Program Management
  • Align the Research & Development Plan across functional lines. Partner with functional leads to ‘pressure-test' assumptions and integrate function planning into the development plan (e.g. REED, CMC, Regulatory, Clinical, Biostatistics, Safety, etc.). Ensure that the plan is realistic for all R&D functions while ensuring that BD, Alliance, and Commercial functions are aligned
  • Works closely with Research Project lead to outline the discovery triaging funnel, timelines for delivery on in vitro/in vivo data and critical milestone to ensure delivery
  • Drive cross functional early asset team to prepare early criteria for selection of lead candidates, Target Value Profile and development plans to deliver differentiated products under the scientific and medical leadership of the Research Project Lead while including regulatory, commercial, legal and alliance potential strategies
  • Define the interdependent deliverables and ensures that quality, risk, cost, time are managed within the approved plan to drive delivery of early asset roadmap milestones and objectives on time and on budget.
  • Validate the technical integrity of the project team plan ensuring that the technical data is reviewed and discussed at the project team meeting for appropriate decision making on follow-up actions
  • Update project plans, timelines, budgets and milestones regularly (on time) in the appropriate tool to ensure data for metrics reporting is accurate
  • Proactively manage changes in project scope, anticipating potential problems (potential resource bottlenecks, risks to critical milestones, inefficient processes and resource variance) and proactively develops and seeks approval for risk mitigation plans.
  • Accountable for ensuring any agreed change is implemented as required
  • Responsible for supporting functional leads in vendor selection and management
  • Closely and proactively monitors the execution of plans, measures result, communicates deviations/discrepancies to Asset Team, specifically focusing on:
  • Deliverables on time / at risk
  • Key milestones
  • Budget / Resource
  • Contingencies
  • Resource constraints if required
  • Issues and correct deviation to ensure successful project delivery


Risk Management
  • Apply a comprehensive risk management methodology that proactively identifies program risks and opportunities together with developing and delivering appropriate contingencies and/or corrective actions to support the team in development of solutions to project conflicts and issues
  • Apply a deep understanding of risk management methodology in using risk to communicate effectively with Governance bodies and underpin project strategy and delivery.


Budget and Resource Management
  • Partner with the Research Project Lead and function leads to ensure that budget, resource management and project controls are established.
  • Manage project budget and resource plan in partnership with the Research Asset Lead, Finance cost controller, function heads and function representatives on the team
  • Accountable and responsible to lead budget sessions that align with Finance budget/forecast calendar delivering and to translate board decisions to team and project budgets
  • Ensure actuals are properly recorded and coded to the project
  • Ensure all supportive materials and data are provided for tax credit requests on due time


Knowledge Management
  • Perform “lessons learned workshops” to identify cross functional learnings to be applied across the portfolio on an as-needed basis (at minimum at stage / gate)
  • Develop a scientific intelligence mindset and use this approach to challenge plans and decisions with the team


Communication & Reporting
  • Effectively communicates project expectations to team members, senior leaders and the broader organization. Escalates issues to team members and stakeholders in a timely fashion.
  • Prepares and manages governance interactions on behalf of the Research Project Lead.
  • Define and implement a communication strategy / plan for the project that supports the most effective team empowerment and progress


In return, you will bring:

Education
  • Bachelor's Degree in Science. PhD or Pharma D is a plus.
  • Certification in Project Management.


Experience
  • This role requires full understanding of drug development business processes.
  • 5-10+ years' experience in the Pharmaceutical / Biotech industry and with an experience of the early drug discovery/ development process, CMC, Phase I/II and project management. Individual should have spent some time in managing early discovery programs, have a good understanding the science, therapeutic areas and process of early discovery/pre-clinical
  • Experience working within 1-2 functional area such as research, preclinical, CMC or clinical is required. US / EU pharmaceutical regulations experience is a must
  • Proactive and agile to work in a fast-paced environment. The successful candidate will have sound judgment, problem solving, leadership skills and emotional intelligence to lead cross-functionally and identify solutions. Candidates should be able to demonstrate ability to work collaboratively with cross-functional team members
  • Financial acumen to develop/manage program budgets
  • Strong experience in facilitating project team meetings, cross-functional communication, decision making and ensuring alignment with internal/external stakeholders.
  • Experience at working both independently and in a team-oriented environment with minimal supervision
  • Demonstrated ability to effectively prioritize, multitask and execute tasks in a fast-paced environment is crucial
  • Important sense of urgency and ability to pace the team's work to achieve milestone achievement in highly competitive environment
  • Strong customer and patient focus


Communication & Interpersonal Skills
  • Written: Excellent
  • Verbal: Excellent
  • Interpersonal: Excellent


Travel

+/- 25% Domestic and International may be required

Languages

English, French is a plus

To learn more about this opportunity, apply today!

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.