Head, Clinical Development
ROLE AND RESPONSIBILITIES
You will be responsible for development of international clinical plans (mainly in US and EU), the oversight and interpretation of clinical trials data and have clinical interactions with multidisciplinary scientists across the company including the CSO, COO and Chief, Clinical Operations. The position reports to the company’s Chief Executive Officer. The location of the position is in New York.
Essential Duties & Responsibilities
- Devise strategy for, develop and implement clinical plans for drug
- Interact with key opinion leaders to assure implementation of latest clinical thinking and guidelines into clinical development plans and company access to most current relevant industry developments
- Develop regulatory strategy in response to regulatory guidelines and competitive intelligence in conjunction with project team members, regulatory affairs and senior management
- Develop phase I-III clinical protocols in patients
- Lead preparation of clinical portions of all relevant regulatory filings (such as IND/IMPD, BLA/NDA/MAA) and review sections from other functional areas
- Work together with key opinion leader clinical investigators and coordinates their activities during the life of the clinical program and beyond
- Develop strategy for and work with the company’s specialists within transplantation and the company’s advisory board to obtain strategic input into clinical program development
- Work closely with other functional areas outside (CRO based) and within the company (clinical operations, data management, biostatistics, clinical pharmacology, preclinical) to facilitate the execution of clinical trials and programs
- Serve as clinical (and medical) resource for clinical issues raised by internal and external collaborators, investigators, consultants and business development and investor contacts
- Serve as lead clinical (and or medical) representative with regulatory agencies
- Provide strategic input on new product concepts, long-range strategic plans and potential licensing opportunities
- Has leadership role in collaborations with strategic partners.
- Supervise and is accountable for the generation of and messaging in clinical program and regulatory submissions
- Accountable for success of clinical development strategy
- Represent the company at scientific, industry, regulatory, advocacy and financial community meetings and presentations, as well as other public relations opportunities.
- Monitor clinical trials for safety and insure timely reporting of safety signals to regulatory authorities
Core Competencies, Knowledge and Skill Requirements
MD in clinical immunology, allergy, autoimmune diseases, nephrology, transplantation or hepatology a plus but other specialties are considered, particularly those with expertise in clinical development in the field of transplantation
Demonstrated scientific and therapeutic expertise
Excellent written and verbal communication skills and proven ability to work in a collaborative environment
Five to ten years of pharmaceutical development experience; Clinical development of approved drug(s) is a plus; Five to ten years’ experience in transplantation drug development is preferred
Experience with interactions with regulators and business partners preferred
Collaborative and flexible in personal interactions at all levels of the company
Ability to work proactively and effectively, with exceptional creative problem solving skills
Proven strategic planning and communication skills across multiple disciplines
Demonstrated ability to work with senior management in providing input to setting and executing on corporate objectives
Significant travel, up to 50% at some periods, required
Communication & Interpersonal Skills
Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders and employees.
Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
Dynamic and innovative clinical scientist with a well-developed sense of teamwork.
Company is a fast-moving small-medium company, with a sense of urgency around what we do, and a successful colleague can manage ambiguity and uncertainty successfully, and can develop and execute project plans within a busy environment
MD in transplantation
Five to ten or more years of clinical trial experience in a similar role at a pharmaceutical, biotechnology or CRO company
Ability to effectively manage multiple clinical projects concurrently
Travel, Physical Demands And Work Environment
Regularly required to operate standard office equipment
Ability to work on a computer for extended periods of time
Regularly required to sit for long periods of time, and occasionally stand and walk
Regularly required to use hands to operate computer and other office equipment
Close vision required for computer usage
Occasionally required to stoop, kneel, climb and lift up to 20 pounds