Director, Clinical Development
Company: Emergent BioSolutions Inc
Posted on: February 25, 2021
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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.--
Essential Functions Reasonable accommodations will be made to
enable individuals with disabilities to perform the essential
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
- Provide hands-on leadership to the Clinical Development Product
- Actively promote Emergent's Core Values
- Inspire and mentor colleagues to promote operational
excellence, utmost efficiency and on-time, on-budget execution of
- 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
- 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
- Lead or contribute to, as appropriate, the development of,
review and approve clinical development plans, protocols,
investigator brochures, informed consent and other study related
- Oversight of CROs and other vendors as necessary.
- Collaborate with Regulatory Affairs for the preparation and
execution of study related documents, procedures, and
- 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,
- Serve as the Medical safety expert for subjects in clinical
- 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
- 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
- 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
- Ability to manage multiple projects in parallel in a demanding
- 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. Emergent
BioSolutions is an Equal Opportunity/Affirmative Action Employer
and does not discriminate on the basis of race, color, religion,
gender, age, national origin, disability, Protected Veteran status,
sexual orientation, or any other characteristic protected by
federal, state or local law. Information submitted will be used by
Emergent BioSolutions for activities related to your prospective
employment. Emergent BioSolutions respects your privacy and any use
of the information submitted will be subject to the terms of our
non-solicited resumes or candidate submittals from
search/recruiting agencies not already on Emergent BioSolutions'
approved agency list. Unsolicited resumes or candidate information
submitted to Emergent BioSolutions by search/recruiting agencies
not already on Emergent BioSolutions' approved agency list shall
become the property of Emergent BioSolutions and if the candidate
is subsequently hired by Emergent BioSolutions, Emergent
BioSolutions shall not owe any fee to the submitting agency. ABOUT
EMERGENT Protecting and Enhancing 1 billion lives by 2030 focuses
our energy to improve the quality of life for individuals around
the world, giving them the opportunity to experience the fullness
of life. Our drive towards this vision informs all of our
actions-whether it is our approach to product development,
manufacturing, encouraging employee health and wellness or giving
back to the community-we strive every day to achieve this shared
goal. WE BELIEVE IN OUR VALUES
- Stand shoulder to shoulder no matter what
- We combine our best thinking and communicate openly to support
- Break through thinking
- We take smart risks, pursue innovation and challenge ourselves
to constantly improve.
- Own it always
- Every person at Emergent is engaged and accountable for
delivering on our commitments.
- Compete where it counts
- We set the right goals and respect each other as we conquer
Keywords: Emergent BioSolutions Inc, Washington DC , Director, Clinical Development, Healthcare , Gaithersburg, DC
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