Director of Preclinical Research
3 weeks ago
**Director, Preclinical Research(Marlborough MA)**
Our client is recruiting for a Director, Preclinical Research, based in Marlborough, MA.
The Director, Preclinical Research will lead strategy and execution for the preclinical evidence necessary to competitively position company products for domestic and international regulatory and clinical acceptance. This individual will draw upon multiple engineering and scientific disciplines including computational and systems modeling, bioengineering and veterinary sciences to drive high quality internal and external preclinical studies. This leader will focus on developing best in class tools and processes as well as mentoring internal scientific and engineering staff to support and accelerate innovation in electrophysiology.
The Director, Preclinical Research, will serve as a member of the R&D/Clinical leadership team as a key partner in driving innovative product development. This highly visible role will influence executive strategy and play a critical role in developing best practices for clinical outcomes. Responsibilities include:
Demonstrate execution excellence and deliver preclinical evidence to offer differentiated value to advance innovation.
Develop robust preclinical plans and evidence-based strategies for an aggressive R&D portfolio that minimizes risk to product approvals, ensures patient safety, and increases product adoption to our customers.
Work cross-functionally with Clinical, Regulatory, Quality and Medical Affairs to identify and understand potential patient risks associated with products and then develop preclinical plans that meet project timelines.
Provide scientific input and rationale for the highest potential projects in company to effectively direct and utilize available resources.
Develop and direct teams to execute preclinical plans and deliver preclinical evidence for both internal regulatory needs and external publication plans.
Connect externally and engage strategically with, regulators, customers, thought leaders, academia, CROs and other external partners to anticipate industry trends and unmet needs, facilitate innovation, enhance product development and physician testing of Company products in preclinical studies.
Provide strong people management skills and organizational leadership. Develop and strengthen the preclinical talent pipeline.
Qualifications:
An advanced degree (i.e. MS, PhD, PharmD, DVM, MD, etc.) in science or engineering disciplines is strongly preferred.
A minimum of 8 years of experience in a medical device and/or contract research organization is required.
A minimum of 3 years of experience managing or mentoring scientific staff is required.
Experience with managing preclinical and/or clinical studies, including GLP, with external contract research organizations is required.
Track record of new product introduction and product life cycle management is required.
Knowledge of preclinical regulatory requirements for FDA, EU, and other international agencies is required.
Ability to work both collaboratively as a team across various functions in a challenging and changing environment is required.
Familiarity with Medical Device Product Development is preferred.
Business travel of up to 25% is required.
**Benefits**:
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Supplemental pay types:
- Bonus opportunities
Application Question(s):
- Are you ok with Business Travel up to 25% of the time?
**Education**:
- Master's (preferred)
**Experience**:
- Medical Device: 8 years (preferred)
- Management: 3 years (preferred)
- Preclinical Director/Manager: 1 year (preferred)
- Class II/III Medical Device: 5 years (preferred)
- Animal Lab: 5 years (preferred)
- Preclinical Research: 8 years (required)
- Therapy Development for Electrophysiology Applications: 3 years (required)
- Cardio Electric Physiology: 5 years (preferred)
Ability to Commute:
- Marlborough, MA 01752 (required)
Ability to Relocate:
- Marlborough, MA 01752: Relocate before starting work (required)
Work Location: In person
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