VP, Head of Clinical Development

We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world.Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

JOB SUMMARY

The Vice President, Head of Clinical Development leads the clinical development strategy and execution across Emergent Biosolutions' product portfolio, including investigational and marketed products. This role is responsible for overseeing the design, implementation, and management of clinical programs to support regulatory approval, market access, and life-cycle management. The Vice President provides leadership and direction to clinical development teams, ensuring the generation of high-quality clinical data that meets regulatory and scientific standards.

The incumbent collaborates cross-functionally with research, regulatory, medical, manufacturing, and commercial teams to align clinical strategies with enterprise objectives and ensure critical milestones are met. As a key leader, this individual fosters innovation, operational excellence, and adherence to industry best practices while maintaining a strong external presence in the scientific and regulatory communities. Additionally, the VP develops and implements policies, practices, and procedures to ensure clinical programs are conducted with the highest standards of compliance, integrity, and efficiency.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

* Develop and lead the clinical development strategy across all investigational and marketed products, ensuring alignment with corporate objectives and regulatory requirements.

* Oversee the design, execution, and analysis of clinical studies, ensuring data integrity, compliance, and operational efficiency to support regulatory approvals and product lifecycle management.

* Ensure clinical development programs comply with global regulatory requirements, working closely with regulatory affairs to support submissions and interactions with health authorities.

* Partner with internal stakeholders, including Research, Medical Affairs, Regulatory, Manufacturing, Patient Safety, and Commercial teams, to integrate clinical development plans with broader enterprise strategies.

* Provide expert guidance on clinical trial design, protocol development, and study execution. Identify potential risks in study designs or regulatory submissions and implement proactive mitigation strategies.

* Contribute to the development and review of critical regulatory documents, including clinical development plans, study protocols, clinical study reports, and regulatory briefing packages. Support regulatory agency meetings and submission strategies.

* Drive continuous improvement in clinical development processes, ensuring adherence to quality and compliance standards while optimizing efficiencies. Support innovation initiatives for process improvements and value creation.

* Oversee the selection, contracting, and performance management of CROs and other external vendors. Ensure vendors meet planned and unplanned Emergent needs in a timely and cost-effective manner.

* Maintain an external presence in the scientific, regulatory, and clinical community. Track future scientific, technological, and regulatory trends to drive innovation in product development.

* Build and mentor a high-performing clinical development team, fostering a culture of accountability, scientific excellence, and innovation. Identify and develop top talent through coaching and development opportunities.

* Serve as a core member of key strategic committees, providing leadership in clinical development strategy. Effectively balance stakeholder needs, communicate clinical priorities, and align objectives across the organization.

* Other duties as assigned.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

* MD required, with a specialization in a relevant therapeutic area (e.g., infectious diseases, immunology, or related field preferred). Additional training or certification in clinical research or drug development is a plus.

* Minimum 15 years of experience in clinical development, including 5 years of progressive leadership experience managing clinical research teams and programs.

* Extensive experience designing and overseeing clinical trials across all phases (I-IV), with a strong understanding of regulatory pathways and clinical development strategies. Vaccines and biologics experience is preferred.

* Proven track record leading global clinical development programs, including interactions with the FDA, EMA, and other global health authorities. Experience with NDA/BLA submissions and regulatory filing activities is required.

* Strong leadership in cross-functional collaboration with Regulatory, Patient Safety, Medical Affairs, Biostatistics, and Research & Development to drive clinical strategies and decision-making.

* Demonstrated success in leading and mentoring high-performing teams, including oversight of external consultants, CROs, and international clinical trial operations.

* Strategic thinker with a results-driven mindset, able to translate scientific and business objectives into actionable clinical development plans.

* Expertise in clinical trial design, protocol development, and data interpretation, ensuring scientific rigor and compliance with GCP, ICH, and regulatory guidelines.

* Experience managing relationships with governmental funding agencies (e.g., NIH, BARDA, DoD) and global health organizations (e.g., CEPI) is a plus.

* Exceptional communication, negotiation, and organizational skills, with the ability to engage stakeholders at all levels, from executive leadership to regulatory agencies.

* Strong problem-solving and decision-making abilities, with the ability to navigate complex challenges in a fast-paced, evolving environment.

U.S. Base Pay Ranges and Benefits Information

The estimated annual base salary as a new hire for this position ranges from $291,000 to $352,200. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]

Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent

(*Eligibility for benefits is governed by the applicable plan documents and policies).

If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

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.