Director, Program Management

Director, Program Management

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Program Management professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the Sr. Vice President, Corporate Development & Strategy at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

• Lead program management for cross-functional teams including R&D, Regulatory Affairs, Supply Chain, Sales & Marketing and Finance from concept through commercialization.
• Drive milestone achievements and go/no-go decision making to progress projects through development stages.
• Represent the program status, scenarios, and trade-offs to senior management, as well as other internal and external stakeholders (alliance management).
• Support development of regulatory documents and government agency interactions.
• Competency in high-level strategic analysis and detail-oriented execution.
• Engage external stakeholders including KOLs and PIs.
• Accountable for integrated development plans.
• Develop program budgets and track spend vs budget.

ESSENTIAL FUNCTIONS

Core Responsibilities:

• Accountable for creation and maintenance of development plans for internal pipeline.
• Utilize program management best practices to identify variance between plan and actual results on regular basis.
• Ensure alignment of program scope and strategic business objectives and applicable ISO, GMP and FDA regulations.
• Ability to influence and reach alignment in a matrix organization.
• Ensure compliance with all company product development processes and industry standard best practices (e.g., Design Control).
• Participate and lead all key technical and design reviews and constructively challenge the team and the organization to rethink assumptions.
• Determine and negotiate resource assignments with functional managers and other business leaders and own the decision(s) related to resource assignments within the project.
• Designate roles, responsibilities, goals and deliverables to all core and extended team members.
• Contribute to the overall improvement of product development process effectiveness.
• Translate the business and technical strategy into action items.

Additional Responsibilities:

• Assist in evaluations, negotiations and contracting (e.g.,vendors, suppliers) where appropriate.
• Prioritize actions items in development (e.g., document review)
• Assist Marketing in assessing competitive threats.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership qualifications include, among other requirements:

• Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Serving as a role model for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

• Bachelor’s Degree is required, advanced degree (MBA or Masters or PhD in a life sciences scientific discipline) preferred.
• 10+ years of experience in program management ideally with both drug and medical device processes.
• Thorough understanding of the drug and device development and commercialization process and essential activities across all key functional areas.
• Significant experience working across functional groups especially clinical, regulatory, supply chain and marketing.
• Experience leading multi-disciplinary teams in the planning and execution of projects.
• Proficiency in Microsoft Project and SmartSheet.
• Excellent written and oral communication skills.
• Proactive and hands-on with a high level of self-motivation and drive.
• Ability to work independently.

WORKING CONDITIONS AND PHYSICAL DEMANDS

• Some travel may be required.
• Flexibility to accommodate teleconferences outside of regular working hours.

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