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.
- 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.
- 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.
- 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.
- 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.
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.