Require Director Training / Medical in Clinical Development Services Agency | 95000 per month

Translational Health Science and Technology Institute (THSTI) is a part of the inter-disciplinary Biotech Science Cluster coming up at Faridabad in the National Capital Region (NCR). The interim laboratories of the Institute are located at Gurgaon in the NCR. THSTI is designed to be a dynamic and interactive organization with a mission to conduct innovative translational research and develop research collaborations across disciplines and professions to accelerate the development of concepts into tangible products to improve human health.
Clinical Development Services Agency (CDSA) is an extramural unit of THSTI and has been established as a not-for-profit society to provide cost effective, high quality preclinical and clinical product development support services to meet the country’s growing healthcare needs. It will tend enterprises; particularly SMEs involved in new technology innovation and facilitate translation of scientific know-how into viable products.
The early focus of the CDSA is to enhance clinical trial capacity in India as per international standards. This would include (a) developing Centres of Excellence (CoE) in clinical research through partnerships with leading institutions conducting clinical trials in India (b) providing comprehensive and sustained training in clinical research through these COEs to build a cadre of world class investigators capable of conducting clinical trials for regulatory submissions.

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Post: DIRECTOR TRAINING
Salary: Up to Rs. 95,000/- (consolidated) per month
Qualification:
ESSENTIAL: MD/PhD with a working knowledge of drug development, as well as thorough experience in the design, implementation, monitoring and management of clinical trials. Research experience in life sciences, clinical sciences, or pharmacology;
DESIRABLE: Experience in initiating scientific/medical education or training programs and In depth knowledge of Good Clinical Practices (GCP) and quality standards
SKILLS: The Director Training must demonstrate strong scientific evaluation ability. S/he must possess excellent communication skills in written and spoken English and interpersonal skills to interact effectively with senior leaders within the organization and outside.
Job Profile:
-Lead setting up of training academy in coordination with national and international institutions.
-Facilitate training needs assessment amongst organizations/ agencies in India conducting clinical trials for drug / vaccine development
-Lead development of training modules on Good Clinical Practices (GCP), Good Laboratory Practices (GLP), clinical operations, clinical trial design and regulatory affairs, project management, data management & biostatistics, pharmacovigilance & medical monitoring, epidemiology, etc.
-Lead dissemination of scientific and medical education for effective clinical product development across geographical sites in coordination with national and international experts on clinical trials.

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Post: DIRECTOR Medical
Salary: Up to Rs. 95,000/- (consolidated) per month
Qualification:
ESSENTIAL:
M.D. (Pharmacology or Medicine) with a minimum of 7-8years R&D experience in pharmaceutical/biotechnology industry.
Demonstrated sound knowledge of clinical regulatory standards and guidelines
Experience in New drug/ vaccine development from Phase I onwards
Experience in preparing study related documents: Protocol, IB and CSR
Experience in AE and SAE management as per regulatory requirement
Experience in pharmacovigilance.
SKILLS:
Proven ability to foster a collaborative team environment.
Supervisory skills including clinical mentoring and coaching skills.
Excellent written and oral communications skills in English.
Job Profile:
-Provide guidance and leadership in designing, implementing and monitoring clinical trial programs executed by CDSA or its partner organizations.
-Participate in the development of clinical/product development plans.
-Planning, executing and reporting clinical trials
-Solicit expert advice, develop collaborative relationship with key experts and investigators and interface with preclinical scientists
-Serve as clinical lead for discussions with regulatory agencies.
-Provide medical input and oversight to the clinical trials
-Provide medical safety surveillance.

General Info
1.   Appointment will be made on contract subject to annual renewal based on good performance.
2.   The salary is a consolidated sum without any other benefits.
3.   CDSA is likely to introduce a contract career path that will offer higher remuneration with stringent performance management system. Selected staff will be eligible for the contract career path positions.
4.   Positions will be initially based in the CDS As interim office at Gurgaon and will be shifted to its permanent campus in Faridabad when ready.
5.   The experience requirement specified shall be experience acquired after obtaining the min. educational qualifications required for the post.
6.   The qualification-, experience, emoluments and other requirements for the positions may be modified at the discretion of the competent authority. In case candidates are not found suitable for the positions notified, they may be offered lower positions on the recommendation of the Selection Committee.
7.   Persons working in Govt or Public Sector undertaking should apply through proper channel or produce 'No Objection Certificate' at the time of Interview.
S.    Incomplete applications will stand summarily rejected.
9.   In case a large number of applications are received for each post, screening will be done to limit the number of candidates to those possessing higher relevant qualification
10.   Only shortlisted candidates will be called for interview.
11.   Number of positions filled will be as per the need and availability of the suitable candidates.
12.   Canvassing in any form will be a disqualification-
Interested candidates may please send their applications with a cover letter indicating their motivation for the position
(150 words) their current CV and three references to Program Director. Cluneal Development Services Agency. 496,
Udyog Vihar Phase ID, Gurgaon- 122 016, Haryana. India.