Medical Director Diabetes Sotagliflozin

Bridgewater, NJ 08807

Post Date: 11/27/2017 Job ID: 281080-0_1 Category: Pharmaceutical Salary: $200,000 to $290,000
Medical Director Diabetes Sotagliflozin
Location: Bridgewater, NJ
Industry: Pharmaceutical / Biotech
Job Category: Research & Development

Position Description:
1.The ideal candidate will demonstrate robust knowledge and clinical experience in Type 1 Diabetes (T1D), solid industry experience, and will be responsible for the ideation, design, and execution of phase 3b/4 clinical trials, targeted to demonstrate and further support the treatment unmet needs in adults with T1D, and the correspondent value of Sotagliflozin in that patient population.
2.This role will have the opportunity to make a difference for patients with T1D by ensuring that the proposed phase 3b/4 trials will address T1D patients' unmet needs.
3.The candidate must have a good understanding of the global and US regulatory, compliance and legal frame work.
4.Identify clinical data gaps and evidence generation needs that will appropriately support patient access and clinical use of Sotagliflozin in T1D
5.Plan, design and ensure flawless execution of robust phase 4 clinical trials of sotagliflozin in T1D, providing solid scientific data in support of the LCM of the brand
6.Identify and interact with key external experts to ensure the highest scientific standards and clinical relevance of the phase 4 trials in T1D
7.In close collaboration with relevant internal and external partners, design and execute phase 4 trials within timelines and budget framework,
8.Ensure appropriate analysis and publication of data derived from the trials
9.Identify and work with statistics on data mining and data analyses of primary and secondary data
10.Reports to Global Medical Lead, Sotagliflozin
11.Pro-active management of projects and studies
12.High degree of autonomy

Key Cross Functional Interfaces:
1.Clinical Operations
2.KTL and Scientific Communications Group
3.Scientific Communications
4.Clinical Product Leads
5.Marketing counterpart
6.KOL community
7.Value & Access counterpart
8.Stats & Data Analytics lead

Educational background
1.Medical degree (MD) or PhD
2.Documented scientific & clinical knowledge of T1D is required
3.Previous experience with clinical trial design and execution in diabetes (T1D is required)
4.Language skills: English

Experiences competencies and specific knowledge
1.Strong experience >5 years in Pharma clinical development
2.Understanding of clinical needs in patients with diabetes (T1D is a must)
3.Knowledge of KOLs in T1Diabetes and correspondent study sites' capabilities
4.Understanding of Global and US compliance and legal requirements for phase 4 trials
5.Ability to understand and simplify scientific concepts
6.Knowledge of the Global & US regulatory landscape
7.Strategic thinking and prioritizing capacity
8.Business and customer oriented
9.Demonstrated Innovation/Creativity in clinical trial designs (especially in T1D)
10.Adaptable, flexible
11.Ability to work in an international matrix organization
12.Ability to have demonstrated interpersonal/communication skills (scientific and non-scientific community as a target group)
13.Team spirit and teamwork ability
14.Hands-on is a must

Position Details:
1.Willing to travel when necessary
2.Visa Candidates Not Considered
3.Base Salary very competitive, commensurate with experience
4.Full-time Benefits
5.Relocation Assistance Available - Yes
6.Bonus Eligible
7.Not Overtime Eligible
8.Interview Travel Reimbursed - Yes
9.5+ to 7 years experience
10.Seniority Level - Director
11.Management Experience Not Required
12.Minimum Education - Doctorate Degree

Ken Kupersmith
Executive Recruiter

Ken's relationship with his clients and candidates is one of personalized, knowledgeable service. His primary focus is helping companies acquire the top talent they need to grow, and working with candidates throughout their careers to put their skills to their highest and best use.Ken's practice focus is in the recruitment of Medical Affairs, MSLs, Regulatory Affairs and Medical and Scientific Writers.
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