Director Global Med Affairs
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.
The Director, Global Medical Affairs will report to the Vice President or Exec. Dir, Global Medical Affairs/ Global Disease Lead. He/she will be headquarters based, and will provide scientific/medical leadership and support for compounds in various stages of clinical development, as well as approved products within a therapeutic area. This individual will support the design and implementation of a strategic disease area medical plans, under the direction of the Global Disease Lead, and in coordination with the Global Franchise Team. They will serve as the medical disease expert. They will also take a leadership role for the execution of Celgene sponsored global medical affairs trials, taking responsibility as the Clinical Research Scientist of a study, from conception to protocol writing, site selection, medical oversight of the study, medical monitoring, to study close out, data analysis, publication and clinical study report writing. They will also assist in the evaluation and support of investigator-initiated trials (IITs). He/she will represent Global Medical Affairs as needed on behalf of the Global Disease Lead, serving as a therapeutic area expert in scientific, strategic and tactical discussions and presentations with internal colleagues, including the Global Franchise Team, as well as with external experts and investigators. They will be responsible for the content and execution of Global Medical Affairs Advisory Boards and are able to moderate an advisory board on behalf of the Disease Team, as needed.
Responsibilities will include, but are not limited to, the following:
1. Leadership responsibilities: Strategic and Tactical
- Represent Global Medical Affairs in cross functional teams/meetings, e.g. Project Teams, Clinical Sub-teams, and Medical sub teams
- Collaborate with all Regional Disease representatives and functional teams in Medical Affairs on Disease strategy and tactics
- Support/lead Medical affairs cross-functional sub team meetings
- Support/lead in the execution of Global advisory boards and steering committee meetings, but also be involved in assisting the regions on critical globally impactful advisory boards.
- Perform, as needed, research and analytics and provide recommendations to support quality medical decisions regarding clinical research, consultancy, and internal planning.
- Conduct research and provide directed analytics and valuable backgrounders, as well as provide recommendations to guide Medical Leadership Investigator Initiated Trials (IITs) decisions.
- Represent company at professional meetings, congresses, and local symposia.
2. Deliverable responsibilities: Strategic and Tactical
- Assist with Global Franchise Disease Strategy and Plans
- Track and coordinate with Regional Medical Affairs tactics in Disease Plans as well as needs to allow strategy updates
- Partner with Scientific Communications on developing Disease publication strategy, gap analysis, key messages in coordination with the Regions
- High quality scientific/clinical input and review of (as needed):
- Disease strategy/plans
- Abstracts, posters, slides, manuscripts in disease area
- Educational materials in disease area including slides, webcasts, etc.
- Cooperative group proposals, study concepts, and IIT proposals and protocols in disease area
- Key Opinion Leader (KOL) Steering committee meeting objectives, materials
- Clinical Development Plans (CDPs), Commercial Brand Plans, Integrated Disease Plans
- Open Data Questions process (ODQs) in disease area
- Scientific educational grant requests
- Patient advocacy grant requests in collaboration with the Advocacy team, serving as matter of expert.
- Drive the planning and execution of Global Medical Affairs Sponsored Trials, within appropriate standards for compliance, quality, timeliness, and budget.
- Seek input from experts in the field on protocol design
- With Global Medical Affairs Disease Lead, seek approval for study and budget through Hematology and Oncology Development Committee (HODC)
- Author protocol and follow through approval process with Internal Review Committee
- Collaborate with Project Team and Clinical Operations on study start-up, to include site selection, Informed Consent development, Investigator meeting(s)
- Develop Medical Monitoring plan, and review data on an ongoing basis
- In collaboration with statistics, develop statistical analysis plan
- Develop activities to enhance patient recruitment
- Review of ongoing tables, figures and listings along with patient profiles to determine safety and efficacy endpoints for company sponsored and/or registry studies.
- In collaboration with statistics review data, prepare abstracts and publications, and prepare Clinical Study Report.
- Assist with scientific searches, data summaries, preparation for site visits/corporate visits/payor presentations
- Track priority Medical Affairs tactics and performance to goals/budget
3. Actively engage/interact with key stakeholders, including:
- Med Affairs partners in disease area
- Global Medical Affairs Leadership
- Market Access
- Clinical Research & Development
- Translational Development
- Regulatory Affairs
- Project Leadership
- Investigators, Study Chairs, KOLs
- Global Study Steering Committees
- Global Scientific Advisory Boards and Regional Advisory boards with global impact (Registries)
- Advocacy groups
- Cooperative groups
The ideal candidate will have the following mix of professional and personal characteristics:
- Advanced degree in life sciences such as hematology, oncology, pharmaceutical drug development, molecular biology, genomics, cancer biology, etc.
- Solid experience in medical affairs or clinical development in hematology or oncology with at least 7 years of industry experience.
- Experience in the conduct of clinical trials from conception to close-out in hematology/oncology preferred.
- Excellent analytical skills and solid experience in translating medical/clinical information into medical affairs strategies. Experience with mining of genomic information from tumor databases and other bioinformatics skills will be a strong plus.
- Proficiency in scientific and clinical data review and interpretation.
- Matrix leadership of cross-functional teams.
- Strong organization skills.
- Superior people skills.
- Excellent oral and written communication skills, including presentations to large groups, facilitation of interactive discussions, and 1:1 discussions with thought leaders.
- Demonstrated customer focus orientation & credibility with customers.
- Knowledge/application of data sources, reports and tools for the creation of solid plans.
- Hard working with a can-do attitude
- Strong leadership skills
- Possess experience creating and managing budget
- Regular travel will be required (approx 20%)
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.