Title: Executive Director Clinical R&D
The Executive Director of Clinical Research and Development (R&D), is responsible for the scientific, clinical, operational, and fiscal activities related to the Clinical R&D team. This individual will lead the clinical development programs for Company’s Iron Franchise and key branded generic products, as well as provide key subject matter expertise to portfolio expansion and business development opportunities.
Essential Duties and Responsibilities
Education Requirements and Qualifications
- Establish and assess the strategy for clinical trial planning design, execution, and analysis with assurance of alignment with regulatory activities.
- Lead a team focused on the clinical development programs associated with the branded products in the Iron Franchise, key branded generic products, and business development opportunities.
- Interact with internal and external stakeholders for the clinical strategy and study operations, inclusive of external engagement with consulting healthcare professionals, trial site investigators, Contract Research Organizations, and other vendors.
- Identification and maintenance of key resource support to the clinical project managers for study execution, project management, program management, data integrity, and medical writing.
- Accountability for Clinical R&D compliance with policies, procedures, and standard operating procedures.
- Key contributions to the data dissemination plan for ongoing clinical development programs and for completed studies in conjunction with the Medical Affairs business unit.
- Provide internal and external medical and leadership education to potential clinical development programs.
- Fiscal responsibility for the Clinical R&D Cost Center.
- Evaluate and contribute to potential business development opportunities.
- 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).
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
- Minimum of 12 years of progressive leadership in the Pharmaceutical industry with demonstrated ability leading, coaching and developing staff members.
- Medical degree required, with United States board certification in internal medicine or sub-specialty expertise.
- Excellent interpersonal communication and presentation.
- 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, 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
- International and Domestic Travel as needed is required.