Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
Director of Clinical Development purpose is to provide a clinical development strategy and clinical deliverables for all assets within the matrix development team. In addition, provides medical support across the business units. As medical monitor, the Director of Clinical Development is accountable for providing medical and scientific expertise and oversight for Clinical Trials. This position is located in Gaithersburg, MD.
Medical subject matter expert for the company on assigned products, proposals and due diligence efforts.
As a Leader:
- Contribute actively to the Leadership Team for the Clinical Development Department
- Provide hands-on leadership to the Clinical Development Product Teams
- Actively promote Emergent’s Core Values
- Inspire and mentor colleagues to promote operational excellence, utmost efficiency and on-time, on-budget execution of assigned projects
- Ensure that any effort made by or contributed to by the Clinical Department is performed at the highest ethical standard with priority given to the well-being of our patients and users.
- Understand the fundamental of project management and provide the corresponding leadership in assigning and managing resources and time lines.
As a critical member of Clinical Development Product Teams:
- Lead or contribute to, as appropriate, the development of, review and approve clinical development plans, protocols, investigator brochures, informed consent and other study related documents.
- Oversight of CROs and other vendors as necessary.
- Collaborate with Regulatory Affairs for the preparation and execution of study related documents, procedures, and presentations.
- Serve as the subject matter expert for Clinical/Medical programs to all matrixed functions within the organization (Safety, Quality, Legal, Clinical Operations, Commercial, Business Units, etc.).
- Serve as the Medical safety expert for subjects in clinical trials.
As a critical member of cross-function Product Development Teams supporting Business Units:
- Provide Medical input into portfolio and pipeline development, advancement and acquisition processes.
- Participate in lifecycle development planning, execution and support of Clinical Development activities post-licensure in close collaboration with Medical Affairs.
- The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills
- MD with 5-10 years’ experience in Infectious Diseases or related area in clinical development. Experience in the development of vaccines, immune therapies or chemical and biological countermeasures is a plus.
- Experience with Clinical Development in the US and globally.
- In-depth understanding of applicable regulations (e.g., GCP) and related experience in the context of clinical development of drugs, biologics and medical devices.
- Experience with regulatory authorities, including the US FDA and the EMA. Track record of contributions to successful regulatory meetings.
- Sound understanding of the overall drug development process with particular focus on interaction between various disciplines (scientific and commercial), international regulatory environment and global development processes.
- Sound understanding of product life cycle management, including market support and labeling extension efforts.
- Be a true team player, demonstrating respect and transparency in interactions with colleagues and partners, and the ability to delegate to others with trust while providing proper oversight and support.
- Ability to manage multiple projects in parallel in a demanding environment.
- Ability to swiftly adapt to changing business needs.
- Demonstrated skill in working in a cross functional organization in a team environment to produce tangible goals.
- Strong leadership in working with alliance partners, vendors, and external consultants.
- Excellent verbal and written communication skills. Comfortable presenting in public meetings or expert level settings.
PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
- The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.
- The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.