SVP, Clinical Development

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.

The incumbent will be responsible for the development, execution, operation, and management of the Clinical development strategy and programs for Emergent's rapidly expanding drug development, therapeutics, device and vaccine portfolios. This includes oversight and management of Clinical Development, Clinical Operations, Biostatistics, Data Management, Bioprogramming and Pharmacovigilance Functions.

ESSENTIAL FUNCTIONS

• Lead a team of over 100 FTEs + contractors to drive the development and execution of multinational clinical program strategies, studies and trials, aligned with Business Unit and Corporate Strategies.
• Ensure that scientific rigor, creativity and innovation are upheld in all clinical initiatives and contribute to senior level discussions assessing development strategies, business development opportunities and commercial plans.
• Clearly communicate and translate program strategies into clinical studies across all Phases of clinical development and oversee execution.
• Manage the related budgets, program costs, external vendor contracting and other associated business/clinical interfaces.
• Provide clinical and medical oversight for project teams, regulatory agency interactions, business units, manufacturing and other stakeholders for vaccine, therapeutic and device development.
• Collaborate with internal and external partners, investigators and KOLs to design and implement clinical studies.
• Provide leadership for clinical operations, data management, pharmacovigilance, and biostatistics as well as involvement in global regulatory matters.
• Oversee and contribute to drug development strategic plans providing technical and strategic advice to meet milestones and budget.
• Translate findings from research and non-clinical studies into clinical development opportunities through portfolio management.
• Ensure that all studies are conducted all Clinical activities in accordance with accepted medico-legal and ethical standards and pharmaceutical industry guidance.
• Continue to build a team and team structure that can successfully support the execution of strategies and programs within the department currently and as the portfolio of programs expands.
• Develop and build talent within the Clinical Development team through coaching, mentoring and providing inspirational leadership.
• Ensure people development is a priority for the function and the diversity of functions within the Clinical Development Group.
• Contribute to Business Development discussions and decisions regarding new technology assessment and asset acquisition plans.
• Partner across the breadth and depth of Emergent to contribute to the matrix structure and communication paradigms.

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.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

• PhD, PharmD, or MD with a proven track record of taking candidates through all phases of clinical development and licensure.
• 15 or more years of experience in clinical development as a Head of Function in biotechnology or pharma. Late stage development experience (large molecules) is a plus.
• Prior experience in successfully building teams and developing talent across clinical development, clinical operations, data management and statistics.
• A team builder who is able to coach and mentor team members and work closely with employees on their continued development.
• Develops and maintains good relationships, gains the confidence of others and works effectively in a multidisciplinary matrix environment.
• Strategic thinker with creative and excellent problem solving and decision-making skills.
• Resilient self-starter, who can act independently and learn quickly within a rapidly evolving environment
• Excellent communicator with strong interpersonal skills and demonstrated experience managing remote and/or global teams.
• Excellent analytical skills with an ability to critically interpret and use scientific and clinical data to manage risk assessment
• Able to effectively collaborate with other departments and external clients and vendors.
• Ability to manage multiple tasks with deadlines in a fast-paced working environment
• Perceptive, creative, and innovative with the ability to contribute new ideas and to build consensus.
• Experience in global regulatory requirements and guidelines pertaining to drug safety
• High attention to detail and accuracy with a strong commitment to business ethics.

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 accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable 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 Privacy Policy .

Emergent BioSolutions does not accept 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.

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