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Preclinical Program Lead, Ophthalmology - REMOTE
- Permanent
- Biological Sciences, Medicinal Chemistry, Pharmacology
- United States
This vacancy has now expired. Please see similar roles below...
Preclinical Program Lead - Permanent - Remote
Proclinical is seeking a Preclinical Program Lead, Ophthalmology to join a global biopharmaceutical company. This is a permanent role with the opportunity to work remotely.
Primary Responsibilities
In this role, you will spearhead and oversee the planning, execution and evaluation of scientific programs from preclinical through translational stages.
Skills & Requirements:
- MS/PharmD/PhD in Chemistry, Biology, Biochemistry, business, or related healthcare area
- Preferred: PMP or CAPM or similar project management certification or equivalent experience
- Work experience: minimum of 7 years
- Prefer experience within preclinical stage *ophthalmic, otic, and/or neurology
- Working knowledge of relevant therapeutic areas and experience working within development of preclinical through translational stage clinical studies
- Sound knowledge of drug development and understanding of FDA and ICH GCP guidelines
- Proven problem solving and project management skills
- Excellent verbal and written communications skills
- Excellent stakeholder and customer relationship management
- Ability to collaborate across functional areas and geographic boundaries
- Relevant pharmaceutical experience
- Experience in management of studies covering all phases of project execution
- Proficiency with advanced collaboration and task-centric tools (e.g. Microsoft Sharepoint, OneDrive, Box, etc.)
- Proficiency with Microsoft Word, Excel, PowerPoint, Project (or related tools) and capable of maintaining appropriate project documentation
- Agile mindset to adapt to evolving needs internally as well as externally
- Flexible working in a dynamic global environment
- Member of professional organization
The Preclinical Program Lead will:
- Take ownership of assigned biopharmaceutical programs, from initiation through completion, by providing strategic direction and oversight. Responsible for overall clinical development for the molecule.
- Strong scientific foundation with ability to critically analyze and apply evolving scientific information to program design. Ability to lead discussions with key thought leaders in relevant therapeutic/ scientific areas. Stay abreast of emerging technologies and scientific advancements, contributing to continuous improvement of program strategies and methodologies.
- Work closely with team members across different functions, including research, development, operations, regulatory affairs, and quality assurance, to ensure seamless coordination of efforts.
- Develop and maintain project plans, timelines, and budgets, while ensuring that projects adhere to the established goals and objectives.
- Identify potential risks and issues and proactively implement mitigation plans to keep projects on track.
- Respond quickly and effectively to unexpected challenges or urgent issues that may arise during the course of program development.
- Continuously evaluate and enhance project management processes, ensuring that they align with industry standards and internal quality standards.
- Serve as main point of contact for internal and external stakeholders for assigned programs. Facilitate clear and effective communication among team members, stakeholders, and leadership to ensure everyone is well-informed about program progress and potential roadblocks. Communicate program updates, milestones and results effectively.
- Work with department leads to allocate resources effectively, optimizing the utilization of talent and equipment.
- Ensure that programs adhere to all relevant regulatory guidelines and standards, assisting in the preparation and submission of regulatory documents as necessary.
- Maintain comprehensive program documentation, including project plans, reports, and performance metrics.
If you are having difficulty in applying or if you have any questions, please contact Max Robinson at (+1) 857-362-9542 or m.robinson@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
INDSCIC
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