Director, Clinical Safety (MD) (Old Bridge)

Daiichi Sankyo in Old Bridge, NJ

  • Industry: Scientific Research - Health/Medicine/Pharmacology
  • Type: Full Time
position filled
Join a Legacy of Innovation 110 Years and Counting!

With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary

Position leads SMTs and is a recognized product safety expert for assigned Phase 1 and 2a products. Oversee ongoing safety of Phase 3 studies as lead CS physician and serve as the CSPV functional rep at Global multifunctional project team meetings. This position prepares, summarizes, and reviews aggregate safety analyses. Additionally, this position develops and implements integrated project/product risk management strategies and drafts the Risk Management Plan with Level III. This position performs safety assessments and determines the safety profiles of assigned products. This position also works with other CSPV staff and SMT members and serves as the CSPV representative on TR-PT/IPT on Phase 1 and 2a products. This position may review and approve safety documents. Finally, this position also handles moderately complex safety matters, such as CSPV's preliminary proposal for safety monitoring in Phase 2 study with well-known AESI, with manager support.

Responsibilities

1. Safety Expert - Overall: Serves as the physician responsible for safety profile and for leading SMTs for assigned Phase 1 and 2a products. Defines the risk component of the B/R assessment. Has good working knowledge of regulations and guidance related to safety reporting and safety surveillance.
Regarding "late stage", the new hire will help support the clinical development plan including Ph 3 studies including MDACC, Investigator initiated studies, Compassionate Use program (EAP study), Q-Peds study (which is considered Ph1/2). Some early Combination studies including PLexxikon could be considered Ph 1/2 as well.
2. Safety Expert - Signal Identification: Performs more advanced aggregate signal identification activities formulated by manager.
3. Safety Expert - Signal Evaluation: Assists manager in assessing signals by surfacing and assembling relevant data and conducting analyses of datasets.
4. Safety Expert - Risk Mitigation & Communication: Supports manager in recommending and implementing risk mitigation activities. Proposes risk mitigation solutions to management and SMT.
5. Reports and Submissions: Contributes to and reviews safety sections of the NDA, CSR, and IB. May first author white papers involving safety. Provides medical review for US and EU periodic reports. Co-owns RMP with manager.

Qualifications

Education and Experience
  • MD degree
  • 3 years of relevant experience and board eligibility
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Job Title
Director, Clinical Safety (MD)

City
Basking Ridge

Functional Area
CSPV

State
New Jersey
Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality

You may be interested in these similar jobs!
Permanent Medical Director Physician in New Jersey (Elizabeth)
Medical Search International- MSI in Elizabeth, NJ

Medical Director physician job in New Jersey : Locations: Central New Jersey (greater Newark, NJ area) Specialty : Internal Medicine / Family Medicin…

Read More
Executive Director Oncology R&D, Early Development (Irvington)
Daiichi Sankyo in Irvington, NJ

Join a Legacy of Innovation 110 Years and Counting!With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sank…

Read More
Permanent Urgent Care Physician in New Jersey (Trenton)
The Execu|Search Group in Trenton, NJ

Urgent Care physician job in New Jersey : A healthcare organization in New Jersey is currently seeking an experienced, licensed Urgent Care Physician…

Read More
Northeast University Setting (Englishtown)
The Medicus Firm in Englishtown, NJ

Philadelphia Culture Rich Amenities Take in a Broadway show, attend the symphony,watch an Eagles, Phillies, or 76ers game or enjoy learning about …

Read More
RN Opportunity in Old Bridge, NJ - Generous Pay, Full Benefits, No Weekends!!!- Permanent/Full-Time (Neptune)
One Stop Recruiting in Neptune, NJ

Clinical Care Specialist/Staff Nurse opening in , New Jersey. This and other rn jobs brought to you by NursingJobCafe.comWell established Surgery Cen…

Read More
Permanent Physiatry Physician in New Jersey (Jersey City)
Recruitwell in Jersey City, NJ

Physiatry physician job in New Jersey : New Jersey PM&R; Opportunities - Several Across the State Clinical Role: Opportunities in Southern Jersey, as…

Read More
Hospitalist Physician in New Jersey (Elizabethport)
Integrity Locums in Elizabethport, NJ

Hospitalist physician job in New Jersey : Coverage Needed: Date: March 31 Hours: 7:00 am - 5:30 pm Clinical Information: Neurohospitalist expederienc…

Read More
Sales manager/closer (Hoboken)
NIELSEN CHEVROLET in Hoboken, NJ

Nielsen Chevrolet is seeking a qualified candidate to be Sales Manager and Closer. Must have automotive sales manager experience. Must be a leader ab…

Read More
Permanent Plastic Surgery Physician in New Jersey (Brick)
Recruitwell in Brick, NJ

Plastic Surgery physician job in New Jersey : Plastic Surgeon Opening in Northern New Jersey (Commutable from NYC) Clinical Role: Seeking a Board Cer…

Read More
Permanent Hospitalist Physician in New Jersey (Newark)
TEAM HEALTH in Newark, NJ

Hospitalist physician job in New Jersey : TeamHealth has an excellent opportunity to join our Special Operations Hospital Medicine team in New Jersey…

Read More