Other Locations:US- NJ- Summit West
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Director, Operational Launch Strategy (CAR-T)
Job Purpose / Position Summary
This global position will manage multiple Operational Launches and life cycle management for T Cell Therapies within Global Pharmaceutical Development and Operations (GPDO). These therapies represent a significant advancement in cancer treatment technology and patient responses. He/she will work with team members to lead overall project planning, cross-functional team meetings, and the development of updates and presentations for management. This role requires the ability to develop and maintain healthy collaborative and cooperative relationships with team members across different functions, at different levels within the organization as well as external partners.
Major Accountabilities include, but are not limited to, the following:
- Serve as a strategic leader for ensuring cross-functional alignment & communication, tracking toward launch milestones and overall operational readiness for the commercialization of life-saving therapies.
- Lead multiple global cross-functional operational launches, by developing and executing integrated project plans with input from the technical team members, critical cross-functional team members, and executive leadership.
- Align operational launch plans with the Clinical Development Plan and Global Commercialization Strategy including global and regional forecasts, launch dates, and sequence.
- Efficiently manage cross-functional team meetings and engage key stakeholders and represent CAR T Supply Chain on cross-functional matrix teams and with alliance partner(s).
- Work with the critical cross-functional leaders to the development of goals and metrics aligned with business strategy and direction.
- Responsible for the development of communications of the project status, including risk, cost, and value for stakeholders.
- Anticipate project risks, explore contingencies and provide escalation management through product launch.
- Direct team to identify potential ways to accelerate timelines, reduce costs or mitigate risks.
- Promote a culture of collaboration, execution excellence, effective communication and cross-functional problem-solving to become a high-performing team.
- Advocate for all stakeholders to ensure they have the support needed to succeed.
- Point person for sourcing and other governance decisions related to products under his/her responsibility
- Responsible for coaching and mentoring other team members, as necessary.
Leadership, Values, and Behaviours:
- Lead as a change agent in a fast-paced environment to promote flexibility, creativity, and accountability to ensure speed to market.
- Create an environment of teamwork, open communication, and sense of urgency.
- Strong organizational skills to drive collaboration across the company and external partners.
- Build trust and productive relationships with peers and stakeholders.
- Deliver business results through timely and quality decision making.
- Foster a culture of high ethics and compliance.
- Promote a mindset of continuous improvement, problem-solving, and prevention.
- Bachelor’s Degree, preferably in business, science or engineering
- MBA or relevant advanced degree preferred
- At least 10-15 years of pharmaceutical development GMP operations, manufacturing, supply chain, planning or at least 5-7 years of GMP product launch management experience
- Experience in multiple functional areas (process development, regulatory, quality, supply chain, commercial) demonstrating a broad understanding of pharmaceutical development, manufacturing, and/or supply.
- In depth knowledge of all phases of drug development and commercialization, of the functions and processes relevant to drug development and commercialization, and project management principles applicable to the biopharmaceutical environment.
- Experience in breakthrough designation product launch or similarly drug launch environment desirable
- Autologous cell therapy experience beneficial
- Very strong influencing capabilities and must be able to interact and communicate effectively at all levels of the organization
- Background of GMP, and other relevant ICH and FDA guidelines
- Excellent verbal and written communication skills and confidently communicate with all staff levels
- Demonstrated leadership skills and excellent negotiation skills.
- Demonstrated ability to earn the trust of team members and management.
- Proven ability to effectively develop, communicate, and gain support for execution plans with a wide range of stakeholders
- Results oriented individual to execute strategy and meet objectives
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.