Job Description
We are currently seeking a Director, Clinical Development, for our Edison, New Jersey location. This position oversees and manages a regional development program or multiple multinational phase II/III clinical trials in order to achieve a high quality product for the marketplace and business success for Sankyo. You will also finalize clinical development plans, protocol profiles and sections of key submission documents. Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters. Oversee management and performance of CROs ensuring high quality products.
Responsibilities:
In this role, you will prepare Clinical Development Plan, budget and proposed go/no-go decision criteria for a regional development program ensuring the medical and commercial needs and the regulatory requirements are met. (non-MD Senior Director works under the supervision of a MD Director or Senior Director). Oversee preparation of phase II/III clinical trial protocols and clinical trial reports ensuring adequate testing of the highest scientific, ethical and professional standards, appropriate risk management strategies and proper interpretation of the data. (non-MD Senior Director works under the supervision of a MD Director or Senior Director). Manage direct and indirect reports, external partners, consultants, vendors and external budget to ensure the timely and cost-effective implementation of a Regional Development Plan or multiple multinational phase II/III clinical trials. Supervise and mentor direct and indirect reports, as necessary.
Support assessment of CROs and preferred vendors for implementation of clinical development plan for global or regional clinical development programs. Review and approve contracts, work orders and invoices prior to submission to management for approval. Establishes and maintains effective communication and collaboration with functional area peers, including basic research, manufacturing, regulatory, quality assurance, project management, and marketing, as well as thought leaders in order to meet program objectives and support achievement of department and corporate goals. Provides input to non-clinical and commercial functions on medical needs and strategic issues for the therapeutic area. Support assessment of in-licensing product candidates in area of expertise, as needed.
Education/Experience
Qualified candidates must have a MD with formal training in Internal Medicine or therapeutic area related specialty. PhD or Pharm D degree candidates with extensive drug development experience are eligible and will work under the supervision of a MD Director or Senior Director. For MD, a minimum 2 years of hands-on experience with a multi-country, clinical program. For PhD or Pharm. D, a minimum of 6 years of drug development experience and at least 4 years of hands-on experience in clinical development. Knowledge of pharmaceutical business, worldwide drug development and regulatory process. Expertise in complex clinical trial design (i.e. factorial design, etc.) and complex implementation (i.e. including Steering Committees, Safety Monitoring Boards, etc.) as well as the interpretation of scientific data.
Independent thinking, creativity and innovation. Ability to deliver high quality products. Strong interpersonal skills and ability to interface effectively with multinational development teams in a multicultural working environment. Excellent communication, presentation and negotiation skills with emphasis on building consensus. Ability to effectively manage interactions with academic thought leaders ensuring optimal cooperation for achieving program and department goals. Ability to anticipate and facilitate issue resolution in a multicultural working and business environment.
Email: jobs@aarenconsultants.in Get Aaren Jobs Daily @ your Mobile : Sign In Get Aaren Jobs Daily @ your Inbox : Sign In
Posts
