Manager, Medical Affairs Operations
Other Locations:US- NJ- Summit East
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.
Manager, Medical Affairs Operations
The Manager, Medical Affairs Operations, collaborating with the therapeutic area/medical leadership and Senior Director, Global Medical Affairs Strategic Planning will play a key role between the Global Medical Affairs research group and the various operational counterparts in Celgene, globally. The Manager, Medical Affairs Operations will work to achieve successful implementation of investigator initiated trials (IITs), company sponsored trials and post marketing research programs. The position will be responsible for tracking and managing deliverables across the I&I Medical Affairs research portfolio, in addition to other medical affairs projects to ensure strategic level plans are executed in a timely and compliant fashion for achievement of Medical Affairs' goals.
- Acting in concert with medical directors, and other internal stakeholders, serve as a liaison between the company and clinical investigators; develop credible relationships with internal functional leaders.
- Manage review and oversight of IITs, support budget negotiations and contract development with clinical institutions and third party vendors.
- Support the maintenance and update of the standard operating processes (SOPs) and WPs, under the direction of the MA Management, and promote adherence to the current processes
- In collaboration with therapeutic area responsible leads and Senior Director Global Medical Affairs Strategic Planning, facilitate development strategic IIT guidance documents/practices. Manage organizational logistics of IIT proposal intake, review, and tracking of decisions by franchise leads and the Internal Review Committee.
- Support Senior Director Global Medical Affairs Strategic Planning and therapeutic area leaders with franchise clinical initiatives (program quality, tracking against financial targets, metrics/ timelines).
- Developing and performing quality controls on internal databases and documentation repositories under the direction of the MA Management.
- Participate in process development activities for IITs and post-marketing clinical studies and participate in Lessons Learned session to improve existing practices.
- BS/BA in a health-related science or RN
- 7 to 10 years of experience in clinical research, clinical coordinator, clinical nurse role or an equivalent combination of education and experience
- Knowledge of drug development process, FDA, ICH, and GCP guidelines and HCC practice
- Immunology therapeutic area experience is required
- Investigator Initiated trial experience is required
- Medical Affairs experience is strongly preferred
- Ability to use scientific and clinical knowledge to conceptualize study designs
- Proactively anticipate and resolve problems
- Ability to work independently
- Knowledge of clinical trials management systems and tools
- Ability to lead cross functional efforts and teams
- Proficiency in data interpretation
- Clinical project management skills
- Excellent skills in oral and written communication
- Excellent interpersonal skills and ability to communicate effectively with people in different functions
- Good listening skills and a strong willingness/desire to help resolve issues faced by others around them
- Strong presentation skills
- Sound organizational skills
Celgene Leadership Success Behaviors
- Achieve Results
- Demonstrates Character
- Leads Change
- Inspires & Motivates
#LI-POSTCelgene 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.