Director, Clinical R&D - Dermatology, MD
1 day left
- Full Time
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.
Role/Responsibilities: The Director, Clinical R&D, in the Dermatology therapeutic area will be instrumental in supporting the growth of the Company's Inflammation and Immunology franchise by helping to build the value of the current products and develop new products. The incumbent will have hands-on responsibility leading the clinical development team for their assigned therapy area (or indication), designing and executing clinical trials, and running phase 2 and/or phase 3 programs. This position offers potential growth opportunities to the right candidate possessing a combination of intellectual and execution skills and a love of the science. Representative responsibilities will include:
- Define and develop Target Product Profiles
- Design and optimize clinical trial design; ensure clinical trials meet ethical and regulatory standards.
- Conduct medical review and interpretation of efficacy and safety data from clinical trials.
- Responsible for the quality, coordination, medical and scientific accuracy and timeliness of clinical study reports.
- Work with the Executive Director and VP in Clinical R&D, and other cross-functional team members to prepare abstracts, manuscripts and presentations for external meetings, as well as author clinical sections of regulatory documents (IB, IND sections).
- Assist senior management to oversee quality, coordination and timeliness of clinical sections of INDs, Investigator Brochures, CTAs, ISS’s, ISE’s, and clinical expert reports.
- Present and discuss data and findings at relevant team, governance, KOL and regulatory meetings.
- Participate as clinical representative on multidisciplinary Project Teams.
- Establish and maintain working relationships with Study investigators, key opinion leaders, academicians, and Celgene Senior managers and department heads across the corporation
- Ensure adherence to GCP/ICH and Celgene Standard Operating Procedure (SOP) standards.
- Maintain clinical and scientific awareness in area of expertise
- Guide day to day work of Clinical Research Scientists.
- Manage lifecycle requirements and plans for designated indications.
- Understanding of Dermatology drug development process.
- Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements.
- Experience in designing Clinical trial strategies to obtain regulatory approval.
- Ability to provide scientific and clinical expertise to a clinical development program and evaluate scientific and clinical strategies for a product.
- Ability to develop and evaluate strategies for the clinical development of a designated indication and to critically evaluate outside expert advice.
- Experience in Clinical project planning.
- Experience working on global and complex Clinical trials.
- Experience working effectively in a team/matrix environment.
- Strong scientific/technical skills
- Strong interpersonal capabilities and ability to build networks
- Proficiency in anticipating and resolving problems
- Excellent managerial and leadership skills
- Excellent verbal communication and technical writing skills
- Ability to present clearly using scientific and clinical terminology
- Ability to lead cross-functional teams and a true team player
- Possesses sense of urgency and can take initiative
- Project management skills and focus on delivery of results
- People management skills
- Ability to motivate
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.