Remotery

Executive Director – Preclinical and Translational Sciences

Posted Jun 21

This is a fully remote position, open to applicants in United States.

📋 Description

• Establish, convey, and advance the strategy for Translational products that aligns with the broader objectives of 4DMT.

• Prioritize and allocate resources within Translational and other areas to fulfill portfolio requirements.

• Lead decision-making processes with heads of other relevant functional groups concerning indications, targets, and the progression of products from concept through design, preclinical development, and Phase 1-2 clinical testing.

• Offer input on scientific strategy from the initial consideration of new targets through development, including assessments of risk, scientific challenges, resource investment timing, and the development of go/no-go decisions.

• Oversee and coordinate the execution of preclinical study programs for pharmacology studies that support the transition from lead to candidate optimization.

• Design, execute, and document comprehensive pharmacology studies to address preclinical exposure, develop pharmacokinetics and pharmacodynamics profiles, and generate GLP toxicology and bio-distribution packages appropriate for supporting IND submissions.

• Manage budgets and headcounts effectively.

• Design, implement, and oversee externally facing in vivo studies with CROs and academic institutions, including drafting proposals, overseeing budgets, and managing deliverables.

• Plan resources; hire and mentor talent; build the team and enhance technical capabilities.

• Foster collaborations with relevant functions at 4DMT; represent the function at both the corporate level and externally.

• Provide direct, hands-on leadership for all Translational interactions as well as grant writing and management with rare disease advocacy organizations.

• Participate in project teams and direct activities to ensure compliance with regulatory standards for preclinical and clinical research.

• Assist regulatory affairs in the preparation, review, and submission of essential preclinical and clinical regulatory information to agencies worldwide.

• Help define clear human POC study outcome criteria for making decisions on new product candidates.

• Contribute senior-level expertise to alliances, business development, due diligence activities with external entities, licensing meetings, and other critical interactions with public health regulatory bodies.

• Perform other assigned duties; this job description does not limit management’s rights to assign or reassign duties and responsibilities at any time.


⛳️ Requirements

• PhD, MD/PhD, MD, or equivalent qualification.

• Over 12 years of pertinent preclinical and/or translational sciences experience within the Biotech or similar industry.

• At least 4 years of management experience or other relevant work experience.

• Experience in preclinical, translational, and clinical R&D.

• Previous leadership roles within the pharmaceutical/biotech industry or academic medical centers, with a significant background in research and translational experience.

• Recognized for fostering a culture of continuous improvement, innovation, and quality, with a track record of leading and mentoring at the highest levels of achievement.

• Proven team leadership skills and experience within a matrixed organization.

• Exceptional verbal and written communication skills, with a demonstrated ability to effectively present ideas, information, and data in one-on-one discussions, team meetings, and presentations to executive leadership.

• Outstanding time management abilities and adaptability to changing priorities.

• Self-motivated individual who proactively builds effective working relationships and partnerships across disciplines.

• Demonstrates adaptability, flexibility, independence, and resourcefulness; actively participates in a dynamic small company culture, managing multiple activities concurrently.

• Ability to proactively identify challenges; possesses strategic foresight and implements suitable actions.

• Superior verbal and written communication skills.


🏝️ Benefits

• Health insurance.

• Retirement plans.

• Flexible work arrangements.

• Professional development opportunities.

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