Chief Medical Officer

- Lead the clinical development team and those responsible for medical affairs, regulatory affairs and drug safety to determine and communicate the therapeutic benefits and safety of the Company's products

- Ensure the objectives and priorities of all team members align with the corporate strategy and drive accountability throughout the team and the company

- Ensure effective and efficient policies and procedures are in place for respective areas of responsibility and compliance with all regulatory requirements

- Recruit, train and develop high performance talent

- Represent the Company and its programs to external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry, collaborators and partners

- Select and manage an elite portfolio of contract research, medical education, regulatory affairs and drug safety service providers

- Partner with other members of the executive team on overall strategic planning

- Achieving the agreed to financial budgets for the clinical development, medical affairs, regulatory affairs and safety activities

- Develop robust clinical development strategies and oversee execution for both proprietary and biosimilar products

- Support due diligence on licensing and business development opportunities and evaluate technical, medical and commercial merit of potential programs and assets

- Present development updates to Executive Team and Board of Directors

- Provide medical and subject matter expertise in areas of immunology including mastery of the relevant scientific and clinical literature and regulatory environment

- Identify and establish proactive and collaborative relationships with physicians and patient advocacy groups

- Establish, recruit and manage appropriate Medical Advisory Boards

- Establish and maintain relationships with Key Opinion Leaders

- Develop and implement a program for scientific publications and conference presentations

Qualification And Experience:

i. MD with Board Certification required with minimum of 15 years industry experience including management experience leading clinical development, medical affairs and drug safety

ii. Demonstrate experience in developing a drug development strategy integrating clinical development, manufacturing operations, regulatory affairs, and commercialization

iii. Demonstrated experience in developing and implementing a clinical development plan for a rare disease biologic based therapeutic

iv. Demonstrated experience in supporting development and regulatory submission of IND, NDA/BLA and 351(k) submissions

v. Ability to interpret clinical efficacy and adverse event data, including the strengths and weaknesses of study design and the applications of results to standard of care and clinical practice

vi. Demonstrated ability to manage projects to completion, prioritizing tasks and delivering on deadlines with high performance standards and attention to detail

vii. Demonstrated ability to collaborate successfully with multiple functions

viii. Demonstrated experience as a medical educator who embraces peer to peer interaction and has a demonstrated ability to cultivate opinion leaders

ix. Must be able to successfully articulate the clinical, medical affairs, regulatory and scientific affairs strategies to a wide audience including the CEO, the Board of Directors, Company employees, and the investor community

x. Must have strong interpersonal skills; should have proven skills as an effective team player who can engender credibility and confidence within and outside the company

xi. Must have outstanding executive presence, presentation skills and communication skills

xii. Effective leadership, people management, and a team builder management style are essential

xiii. Results-oriented work ethic and a positive attitude

xiv. Must have the highest ethical standards

Remuneration :

An outstanding remuneration package that rewards professionalism and diligence will be on offer for the successful applicant as well as a well defined career path. An excellent package will be on offer for the right candidate, including an above industry base salary for the right person as well as the most complete employee benefit scheme. Don't miss out on this opportunity to join the market leader

Contact Person Name, Address & Nos.:

P.G.Ganesh
Partner
Perfect Placer
Web Site : www.perfectplacer.com
Mobile : 9873663105

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