The Medical Director, Head of Clinical Research and Development (R&D), is responsible for the scientific, clinical, operational, and fiscal activities related to the Clinical R&D functional unit. This Director will lead the clinical development programs
Essential Duties and Responsibilities
Establish and assess the strategy for clinical trial planning design, execution, and analysis with assurance of alignment with regulatory activities.
Lead a strong, efficient team of scientific leaders for the clinical development programs associated with the branded products in the Iron Franchise and the Multisource generic products.
Interaction, as needed, with the internal and external partnerships for the clinical strategy and operations, inclusive of external engagement with consulting healthcare practitioners, Academic Research Organizations, Contract Research Organizations, trial site investigators, and business partners.
Identification and maintenance of key resource support to the clinical operations, project management, program management, data integrity, medical writing, and corporate compliance.
Accountability for Clinical R&D compliance with policies and practices.
Key contributions to the data dissemination plans by the Medical affairs team for completed clinical trials and ongoing clinical development programs.
Provide internal and external medical and leadership education to potential clinical development programs. Develop and maintain the Clinical R&D Cost Center.
Evaluate and contribute to potential business development opportunities.
Inform on leadership initiatives set by the Vice President, Chief Medical Officer and the President, Chief Executive Officer.
Attend, and if relevant, lead in training curricula, symposia, and conferences in order to maintain medical and leadership expertise associated with Clinical R&D's goals and objectives.
Communicate effectively with partners, affiliates, and stakeholders to ensure alignment and time-bound clinical and business commitments.
Adhere to both Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) aligned with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Qualifications and Requirements
Medical degree with United States board certification in internal medicine, surgery, or sub-specialty.
Ten or more years of experience in the pharmaceutical industry or relevant clinical research experience in the academic setting.
Strong analytic skills, problem-solving skills, and medical writing skills. Experience in writing and implementing research protocols, reviewing and interpreting data, preparation of study reports, data analysis, and presenting data to internal and external audiences.
Strong skills in public speaking, interpersonal relationships, team building, and capability of change.
Evidence of successful ongoing career development and leadership skills; additional Medical, Safety, or other pharmaceutical development experience is preferable. Experience as a project team leader with major responsibility for at least one New Drug Application (NDA) submission desired.
Ability to travel and work hours necessary to meet deadlines, including week-ends, as needed
Physical Environment and Physical Requirements
Business travel as required for clinical and regulatory activities.
On-site employment with some flexibility.