Posted in Other 30+ days ago.
Type: Full Time
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.
JOB SUMMARY
The incumbent will be responsible for the development, execution, operation, and management of the Clinical strategy for Emergent's rapidly expanding drug development, therapeutics, device and vaccine portfolios.
ESSENTIAL FUNCTIONS
- Lead a team 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 study concepts and support and mentor a systemic execution.
- 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 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.
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.
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 accommodations may be made to enable individuals with disabilities to perform all essential functions.
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 .
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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