Product Launch Operations Leader, Americas ~ Operations - Emeryville, CA | Biospace
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Product Launch Operations Leader, Americas ~ Operations

Santen, Inc.

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Location:
Emeryville, CA
Posted Date:
6/16/2017
Position Type:
Full time
Job Code:
800408
Salary:
200K plus bonus
Required Education:
MBA
Areas of Expertise Desired:
Operations, Pharmaceutical, Project Management,

Job Description

The Americas Launch Excellence Leader is responsible for successfully managing the launch process of new products on time and on budget.  The incumbent will lead and perform project management duties, transitioning from R&D Project Management Team, to support and complete new product NDA filings with the US FDA, and ensure Santen Inc.’s launch preparedness in the time running up to launch with minimum supervision from US executive leadership team. In partnership with key cross-functional leaders such as Commercial, Medical Affairs, Regulatory, Legal, Supply Chain, Information Technology, etc., the Launch Excellence Leader will develop, communicate, and manage project plans, priorities, and tasks internally and externally, to provide value-add services and strategic thought partnership.

MAJOR DUTIES OF POSITION:

•   Drive forward key activities of post-filings, coordinating activities across multiple stakeholders, removing hurdles, and ensuring decisions are made in a timely manner.
•   Develop a clear definition of launch process focusing on critical launch end to end drivers.
•   Applying experience of launches to proactively identify real or potential issues and developing solutions to assure launch readiness.
•   Spearhead a Core-Team consisting of Medical Affairs, Regulatory, Legal, Pharmacovigilance, Quality Control, Quality Assurance, Marketing, Market Access, Commercial Operations, Supply Chain, Distribution, Information Technology, and other key relevant R&D supporting groups. Provide due diligence, a compiled assessment of progress, bottlenecks, and solutions to support the launch readiness process and to ensure successful alignment across all key functions.
•   Lead cross-functional teams, providing strategic and tactical expertise, to ensure the successful launch of new products.
•   Being the link that enables sharing of accurate & important information between relevant cross functional leaders & teams to ensure assigned goals and objectives are met and that assigned projects are completed on time to high standards within departments budget
•   Serve as the strategic owner of the scope, schedule, and budget for multiple project teams.
•   Drive adherence to high quality project management standards across all assigned project teams, and ensure the constant flow of meaningful project and roadmap communication to project team participants, business stakeholders, and management.
•   Mitigate risks and ensure removal of barriers to a successful product launch.
•   Develop, maintain, and enforce a comprehensive, cross functional launch plan for all new product launches, including post-mortem reviews to identify opportunities for continuous improvement.
•   Responsible for developing the project plan and ensuring work is completed on time and within budget, meeting all requirements acceptable for launch readiness.
•   Manage project budgets, contract milestones and spend, and provide updates on a regular basis to US Executive Leadership Team.
•   Quickly address issues as they develop and leverage the appropriate technical expertise within the organization to resolve such issues.
•   Partner with executive leadership to define the associated roadmap for each launch.
•   Facilitate the resolution of issues or conflicts across the assigned project teams to remove any roadblocks.
•   Ensure that each assigned project team provides consistent status/update information and collaborates with the other departments as necessary.

Requirements

•   Minimum:  Bachelors’ degree in Marketing, Business, or Life Science discipline; MBA or relevant advanced degree preferred.
•   Minimum of 10+ years previous project management experience with at least 5 years relevant product launch experience in the pharmaceutical, consulting, or Life Sciences industries.
•   Experience launching a new molecular entity in the US required
•   PMP certification or equivalent preferred.  
•   Strategic competencies, ability to drive complex project roadmaps with multiple concurrent projects and work streams, and manage executive contributors and stakeholders successfully.
•   Strong communication, influencing, meeting facilitation, and presentation skills.
•   Strong leadership to execute projects
•   Project and Team management skills to optimize resources and deliver results
•   Able to identify and manage risk
•   Able to identify issues requiring escalation and leverage support from senior management when required.
•   Excellent written and verbal skills
•   Detail oriented, able to multitask and meet deadlines
•   Self-motivated, able to work in a team and independently
•   Integrates outcomes across functions
•   Technical knowledge of cross-functional activities required to launch branded products into specialty markets is essential.
•   Excellent time-management skills.
•   Ability to work with cross-functional teams and to address issues in a professional and timely manner.
•   Superior collaboration and communication skills: team building, conflict resolution, stakeholder management, risk management, product management, negotiation & decision making.
•   Demonstrated success in managing, working with and through people, cross-functionally, in establishing goals, and accomplishing objectives and action plans to produce expected results.
•   Previous experience leading cross-functional teams, ideally from product development phase to commercialization phase, preferably in pharma or biotech industries.
•   Must be flexible in handling multiple tasks, while remaining detail oriented, and have the drive and ability to work in a fast-paced, environment.
•   Ability to work under and adhere to strict deadlines, with a keen focus on results.
•   Excellent project management skills, including global cross-functional facilitation skills.
•   Excellent problem solving and analytical skills.
•   Excellent interpersonal skills in a multi-cultural environment.
•   Advanced proficiency in project management, spreadsheet, and database management software is required, along with moderate to advanced proficiency in the Microsoft Office Suite and any other Project Management tools