| Job Description | POSITION DESCRIPTION
Keryx Biopharmaceuticals is seeking a Chief Medical Officer who will serve as a key member of the executive team with accountability for providing strategic leadership as well as operational prioritization and oversight for all scientific aspects of product development, registration, and post-marketing activities. The successful candidate will work directly with the Chief Executive Officer and other members of senior management team to identify and prioritize product opportunities and align development activities with corporate strategy. The Chief Medical Officer will oversee all aspects of Clinical Development, Regulatory Affairs, Drug Safety and Clinical Operations.
This is a rare and outstanding opportunity to serve as a driving force in the successful development and commercialization of Zerenex® along with additional future potential compounds, and one that will provide broad accountability and impact for the successful candidate.
KEY RESPONSIBILITIES:
The Chief Medical Officer will play a key role in providing functional and strategic leadership within the company. The scope of the position will include all aspects of Keryx’s clinical development programs: overall program goals; design of clinical trials; medical monitoring of clinical trials; and internal and external program communications with clinical experts and global regulatory agencies.
The successful candidate will collaborate closely with the CEO and other members of the senior management team to identify and prioritize product opportunities and align development activities with corporate strategy. The Chief Medical Officer will provide regular updates to the Board of Directors regarding clinical programs and other medically related matters.
Additional key responsibilities of the Chief Medical Officer will include:
Lead all aspects of Zerenex® clinical development including key accountability for the European approval for hyperphosphatemia in patients with CKD; overseeing clinical strategy design for new indications and formulations, and ensuring efficient and effective progress of protocol development and implementation in compliance with regulatory guidelines and Keryx’s strategic objectives.
Interact with and represent Keryx to the FDA and international regulatory agencies with oversight of regulatory submissions and clinical responses to regulatory queries.
Represent Keryx externally to investors, corporate partners, and other strategic partners; present data and company progress at scientific conferences and industry meetings; build and maintain solid working relationships with key opinion leaders and leading clinical investigators in the nephrology arena. Establish and foster partnerships with the international scientific and medical community.
Attract and retain a world class scientific team, providing leadership that cultivates teamwork and that optimizes the development
and operating efforts of the company.
Collaborate with the senior management team as required on corporate development initiatives, including financing, product
licensing, M&A etc.
Create and manage an annual budget for the company’s medical and scientific development activities.
Work with the CEO and senior management team to play a key role in establishing, maintaining and managing collaborative working
relationships across internal functional groups.
Lead review and interpretation of study results through written reports and discussions with clinical and scientific staff.
Maintain understanding of clinical and scientific developments in the Nephrology arena to drive optimization of the portfolio by
attending scientific meetings and tracking literature.
PROFESSIONAL EXPERIENCE/QUALIFICATIONS
Keryx seeks an MD or MD/PhD with a record of accomplishment in the pharmaceutical industry including designing, developing, planning, and
managing clinical studies and operations, leading to successful registration and commercialization of products. Experience in the nephrology arena is an advantage, and a comprehensive understanding of the industry’s complex legal and regulatory requirements is essential.
Additional qualifications are as follows:
Excellence in scientific rigor and clinical development skills, demonstrated by a successful track record in overseeing multiple clinical development programs through phase III and registration.
Solid track record of successful interactions with the FDA and international regulatory authorities; strong knowledge of FDA and EMA regulations and guidelines; experience presenting to regulators and playing a leading role in submissions.
Strategic awareness to plan, prioritize and implement product development opportunities in order to optimally achieve Keryx’s business objectives.
A management and interpersonal style that builds alliances internally and externally emphasizing high morale, collegiality, a strong work ethic, effective teamwork and the highest of ethical standards.
A dynamic leader and hands on manager who can positively influence the performance of others to achieve desired results through motivation, clear structure, direction, active communications and coaching.
The ability to build a strong network and credibility with key opinion leaders in the Nephrology medical community.
Highly developed understanding of the competitive landscape to identify long-term benefits for unmet medical needs.
Ability to initiate ways to improve performance and outcomes by developing and implementing novel approaches.
Ability to operate effectively within a small, entrepreneurial and high growth company environment. |
| | Company | | Keryx Biopharmaceuticals, Inc. | Job Code | | State or Province | | New York | | |
|
