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Director Preclinical Development Jobs in Boca Raton, FL

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Director Preclinical Development information

See Boca Raton, FL salary details

$38.4K

$87.7K

$147.1K

How much do director preclinical development jobs pay per year?

As of Jul 1, 2026, the average yearly pay for director preclinical development in Boca Raton, FL is $87,671.00, according to ZipRecruiter salary data. Most workers in this role earn between $66,400.00 and $103,000.00 per year, depending on experience, location, and employer.

What is a Director Preclinical Development job?

A Director of Preclinical Development oversees the early-stage research and testing of drug candidates before they enter clinical trials. They manage preclinical studies, ensuring regulatory compliance, safety, and efficacy assessments. This role involves coordinating with cross-functional teams, external partners, and regulatory agencies to advance promising compounds. Strong expertise in toxicology, pharmacology, and regulatory guidelines is essential. The director plays a key role in shaping the preclinical strategy to support successful drug development.

What are the key skills and qualifications needed to thrive in the Director Preclinical Development position, and why are they important?

To thrive as a Director Preclinical Development, you need deep expertise in pharmaceutical or biotechnology research, strong project management abilities, and an advanced degree (Ph.D., Pharm.D., or equivalent) in a life sciences field. Familiarity with regulatory guidelines (such as GLP), experience using data management and statistical analysis software, and prior leadership roles in preclinical studies are essential. Exceptional communication, problem-solving, and team leadership skills set candidates apart in managing multidisciplinary teams and collaborative projects. These competencies are crucial for successfully guiding drug candidates through preclinical stages while ensuring regulatory compliance and timely project delivery.

What are the typical responsibilities and team dynamics for a Director of Preclinical Development?

A Director of Preclinical Development is responsible for overseeing the planning, execution, and management of preclinical research programs, ensuring that studies meet scientific, regulatory, and project milestones. You will typically work with cross-functional teams including toxicologists, pharmacologists, regulatory affairs professionals, and external partners, fostering collaboration throughout the drug development process. The role often involves reviewing study designs and data, preparing regulatory submissions, and providing strategic direction to advance compounds toward clinical testing. Working closely with upper management, you'll play a key part in shaping research priorities and resource allocation. This position offers significant influence over drug development strategies and opportunities for advancement to higher executive or scientific leadership roles.

What job categories do people searching Director Preclinical Development jobs in Boca Raton, FL look for? The top searched job categories for Director Preclinical Development jobs in Boca Raton, FL are:
What cities near Boca Raton, FL are hiring for Director Preclinical Development jobs? Cities near Boca Raton, FL with the most Director Preclinical Development job openings:
Director Preclinical Development jobs near you
Vice President Regulatory Affairs, Oncology (Drug)

Vice President Regulatory Affairs, Oncology (Drug)

Syncromune

Fort Lauderdale, FL • On-site, Remote

$142K - $188K/yr

Full-time

Posted 25 days ago

Job description

The Vice President (VP) of Regulatory Affairs (Drug) will serve as Syncromune's regulatory leader for the company's drug development programs and strategic partner to executive leadership. This individual will lead the design and execution of global regulatory strategy across the product lifecycle, from IND-enabling activities through clinical development and potential BLA submission.. As a key member of the executive team, the VP will guide interactions with health authorities, and ensure that regulatory strategy is fully integrated into development, clinical, CMC, and corporate strategy.
This is a hands-on leadership role requiring strategic oversight and operational engagement in an early-stage biotechnology environment.
NOTE: This is an oncology focused role, and oncology experience is required. Please also note that there's a strong preference for this person to be located in the Central or Eastern time zone due to work with global colleagues.
Principal Duties and Responsibilities include the following:.
  • Develop and implement global regulatory strategies for drug development programs across preclinical development, clinical development and potential registration.
  • Lead regulatory planning from IND enabling activities through clinical development and potential BLA submission.
  • Advise executive leadership and the Board on regulatory risks, timelines, and strategic regulatory pathways.
  • Serve as the primary regulatory voice in portfolio prioritization and development strategy, and regulatory governance discussions.
  • Establish regulatory risk mitigation plans aligned with corporate objectives and development milestones.
  • Lead preparation for and participation in meetings with regulatory agencies including FDA and other global health authorities (e.g., pre-IND, IND, scientific advice, end-of-phase meetings).
  • Oversee preparation and submission of regulatory filings including INDs/CTAs, amendments, briefing packages, orphan applications, expedited designations and other regulatory submissions as programs advance.
  • Serve as the primary contact with US and global regulatory authorities for drug related regulatory submissions.
  • Drive strategies for expedited programs (e.g., Fast Track, Breakthrough Therapy, PRIME, etc., as applicable) in support of accelerated development pathways.
  • Partner closely with Clinical, CMC, Nonclinical, Quality, and Commercial teams to ensure regulatory strategy is aligned with product development plans.
  • Provide regulatory guidance on clinical development strategy, study design, endpoints, and labeling implications.
  • Ensure regulatory requirements are integrated into CMC development plans and manufacturing strategies for future registration.
  • Support due diligence activities, investor communications, and partnering discussions.
  • Build scalable regulatory systems, processes, and document standards.
  • Ensure timely, high-quality, compliant submissions.
  • Oversee regulatory documentation lifecycle management.
  • Recruit, mentor, and develop internal regulatory talent as the organization grows.
  • Manage external consultants and CRO partners.
  • Foster a collaborative, accountable, and mission-driven regulatory culture.
  • Build infrastructure appropriate for growth from early development to later-stage operations and evolving regulatory requirements
Supervisory Responsibilities:
Directly supervises members of the Drug Regulatory Affairs team. Provides leadership, guidance, and development support to ensure execution of regulatory strategy and submissions. Responsible for recruiting, developing, and managing additional regulatory staff and external consultants as the organization and development programs expand.
Qualification Requirements:
Education:
  • Masters degree required, advanced degree preferred.
Experience:
  • 15 years of regulatory affairs experience in biotechnology and/or pharmaceuticals.
  • Experience supporting regulatory strategy for biologics and complex therapeutic platforms preferred.
  • Demonstrated success leading regulatory strategy for drug development programs from IND-enabling activities through clinical development and potential registration (e.g., BLA/NDA).
  • Direct experience leading interactions with FDA and international regulatory authorities.
  • Experience preparing and leading major regulatory submissions including BLA..
  • Strong understanding of CMC, nonclinical, and clinical regulatory requirements supporting biologics or complex therapeutics programs
Knowledge/Skill:
  • Experience in oncology, biologics, cell/gene therapy, or other relevant modality.
  • Experience in a small or emerging biotech company environment.
  • Global regulatory experience including FDA and EMA, other regions a plus.
  • Demonstrated ability to influence regulatory strategy and decision-making across multidisciplinary development teams.
  • Strong communication, negotiation, and relationship-building skills; ability to communicate complex regulatory strategy to scientific and executive audiences.
  • Excellent interpersonal communication skills; a highly communicative leader who maintains transparency both internally and externally.
  • High level of integrity and professionalism with the ability to operate effectively in a fast-moving, early-stage biotechnology environment.
Working Conditions:
  • The work environment shall be either a virtual office environment, the Company headquarters in Fort Lauderdale, FL, or a combination of both.
  • While performing the duties of this Job, the employee is regularly required to:
      • Primarily sit
      • Frequent standing and walking
      • Lifting up to 20 pounds
      • Repetitive motions
      • Travel up to 50% regionally, some international

Syncromune is an Equal Opportunity Employer.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range: $345K-$375K
This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company's benefit plans.

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