Synergetics · 11 hours ago
Director, Clinical Development
Myrtle Point, OR
Full-time
Onsite
Lead/Staff, Director/Executive
$180K/yr - $250K/yr
5+ years expBausch + Lomb is a leading global eye health company dedicated to enhancing sight for millions. They are seeking a Director of Clinical Development to provide strategic leadership and medical accountability for clinical programs while ensuring alignment with business goals and regulatory requirements.
Health CareHealth DiagnosticsManufacturingMedical DevicemHealth
No H1B
Responsibilities
Serve as Clinical Lead on Core Teams for assigned development programs, providing strategic clinical leadership and driving program-level decisions that impact overall development success
Develop and drive program-level clinical development strategy aligned with target product profiles, business objectives, and regulatory pathways across global markets
Hold accountability for the scientific integrity, sufficiency, and quality of clinical development deliverables to meet global regulatory submission requirements
Own key clinical development deliverables, including protocol design, data interpretation, and risk mitigation strategies, while escalating critical matters to senior leadership as appropriate
Lead Clinical Evidence subteams to orchestrate strategy development and execution with cross-functional partners
Design and oversee clinical studies ensuring scientific rigor, regulatory compliance, and alignment with program strategy
Provide scientific oversight throughout study conduct, including ongoing medical/scientific data review, adjudication of major protocol deviations, and safety signal evaluation
When serving in Clinical Scientist capacity: author study protocols, informed consent forms, clinical study reports, and other study-level documents. Provide protocol training and scientific guidance to study teams
Represent Clinical Development in governance forums, presenting program updates, risk assessments, and strategic recommendations to senior leadership
Ensure all clinical activities comply with GCP, ICH guidelines, company SOPs, and applicable regulatory requirements
Provide clinical/scientific input into disease area strategies and portfolio prioritization decisions
Support business development activities through technical evaluation of potential in-licensing and partnership opportunities
Contribute to the development and optimization of Clinical Development processes, SOPs, and infrastructure to enhance efficiency and quality
Provide scientific guidance to more junior clinical development team members
Qualification
Required
Advanced degree in life sciences/healthcare in a clinically relevant area required; MD, PharmD, or PhD strongly preferred
Minimum 5-8 years of pharmaceutical/biotechnology industry and/or clinical experience with demonstrated impact in leading clinical development activities strongly preferred
Experience in eye health/ophthalmology product development (e.g., small molecule, biologic, combination product) across a variety of ophthalmic disease states is highly preferred
Familiarity with consumer health/OTC product development considered a plus
Track record of successful clinical program advancement and through regulatory milestones across multiple geographic regions is preferred
Proven experience as Clinical Lead on development programs or demonstrated readiness to assume this strategic leadership role
Deep understanding of GCP, ICH guidelines, global regulatory requirements, and clinical development processes
Expertise in clinical study design and working understanding of statistical methodology and data interpretation for controlled clinical trials
Strong scientific writing skills with experience authoring regulatory documents, protocols, and clinical study reports
Exceptional communication and presentation skills with ability to influence diverse stakeholders including senior leadership, regulatory authorities, and external experts
Strong partnership mindset with track record of building productive relationships across R&D functions and the broader organization
Self-motivated with ability to manage multiple priorities and drive execution with minimal supervision
Commitment to scientific excellence, patient outcomes, and advancing eye health innovation
Benefits
Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
401K Plan with company match and ongoing company contribution
Paid time off – vacation (3 weeks - prorated upon hire), floating holidays and sick time
Employee Stock Purchase Plan with company match
Employee Incentive Bonus
Tuition Reimbursement (select degrees)
Ongoing performance feedback and annual compensation review
Company
Synergetics
As Synergetics becomes Bausch + Lomb Retina, keep following us to learn why our newly formed partnership is all about you.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2016-02-10Acquired
1990-04-06IPO
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