VP, R&d Therapeutics
Gaithersburg, MD, USA | Emergent BioSolutions
Industry:Pharmaceutical / Biotech
Job Description:52 people have viewed this job
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.
This is an exciting time to join a company that is playing a lead role as a solution provider in the Public Health Threat space includingcollaborative and innovative thinking to advance solutions for COVID-19. The VP, R&D for the Therapeutics Business Unit will play a critical role in the advancement of two high profile COVID-19 Hyperimmune Globulin development programs with impactful private-public partnerships, in addition to the robust development pipeline of the Business Unit.
The Vice President, R&D is responsible for the overall research and development functions for the Therapeutics Business Unit and a key member of the leadership team that oversees the strategy and manages the P&L. Responsibilities include overseeing the portfolio of pipeline programs from proof-of-concept to licensure.and building strategic partnerships and alliances to align with growth and innovation strategy. This role will have direct oversight of Process development, Bioanalytical sciences,Preclinical research and Pipeline research and develop an infrastructure to support the appropriate range of research and development activities to support new products, lifecycle management of existing products and operations. Innovation
Strong leadership and communication skills are critical for this role, which can be located at either our Head Office in Gaithersburg, Maryland or at our Winnipeg, Manitoba Canada site where the R&D team is located. Frequent travel between Canada and the USA will be required.
Lead multidisciplinary scientific teams in product development programs and projects, coordinating between stakeholders (eg Regulatory, Quality, Clinical, Commerical etc), with direct oversight of the teams responsible for pipeline research, bio-analytical science and formulation, preclinical research and process development teams;
Provide overall leadership to the Research and Development team to drive discovery and development of therapeutics, with a focus on antibodies and other biologics, with a strong focus on innovation and integration of novel technologies to achieve long-term growth strategy
Plan, implement and supervise studies to ensure study deliverables are met according to specified timelines, budgets, quality and resources, working in close collaboration with internal and external stakeholders including project teams, research organizations, regulatory authorities and other stakeholders
Ensure best-practices for research and data integrity standards are integrated in research and development strategies; Maintain quality control and high standards throughout the lifecycle of each project, identifying areas of best practice and process improvement
Build strategic partnerships and alliances to advance strategy, build pipeline and enhance capabilitie
Lead and mentor multidisciplinary scientists and function leaders to develop a high-performance team and a culture of integrity and accountability• Oversee Chemistry Manufacturing & Controls and preclinical sections of regulatory submissions, and participation in regulatory strategy and meetings to support applications and products.
Effective communication of research and strategy to multiple stakeholders including internal teams, management, board of directors and external parties
Ensure optimal intellectual property strategy is integrated into development and life-cycle management programs to deliver long-term value from product portfolio
Support due diligence and scientific assessment of business opportunities.
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
Ph.D. in immunology, biology, bio/chemistry, , pharmacology or medicine with >10 years industry experience in pharmaceutical companies or biotech companies, preferably leading a multidisciplinary R&D function.
Proven track record of providing strategic oversight for R&D, preclinical and clinical study protocols, reports and publications
Demonstrable expertise relating to all aspects of the drug development process
Ability to identify and resolve complex methodological issues relating to programs
Good knowledge of GLP, GCP and regulatory requirements (especially FDA, HC and EMEA)
Proven track record of innovation including peer-reviewed publications and/or patents
Well-developed organizational and interpersonal skills, complemented by attention to detail
Able to find practical and pragmatic solutions in a business environment with strict regulatory control
Finely honed written and verbal communication skills, underpinned by the ability to present clear instructions/directions to teams within the organization and external audiences
Member of scientific societies or holder of recognized achievement awards
Possess both scientific curiosity and ability, and business acumen.
PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job.
This information is available upon request from the candidate.
Reasonable accomOrganizationations may be made to enable individuals with disabilities to perform all essential functions.
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