Executive Director, Preclinical and Translational Sciences

General Summary

This Executive Director position will report to the Senior Vice President, Research & Early-Stage Product Development and lead a team of translational scientists and drug development experts tasked with bringing innovative gene therapies to patients. The incumbent will have a high level of passion for 4DMT’s mission and the ability to operate as an effective strategic and tactical thinker. They will also be effective as a hands-on manager and supervisor of individual work.

Major Duties & Responsibilities

• Set, communicate and drive strategy for Translational products in alignment with the broader organization of 4DMT
• Prioritize and allocate resources, both within Translational and beyond, to meet portfolio needs
• Lead the decision-making process with other relevant functional group heads regarding indications, targets and products’ progression from concept, design, preclinical development and Phase 1-2 clinical testing
• Provide input on scientific strategy from the earliest consideration of new targets through development, including risk, scientific challenges, timing of resource investment and development of go/no go decisions
• Direct and coordinate the implementation of preclinical study programs for pharmacology studies in support of the lead to candidate optimization process
• Design, implement and write-up comprehensive series of pharmacology studies to address preclinical exposure, develop pharmacokinetics and pharmacodynamics profiles and generate GLP toxicology and bio-distribution packages suitable for supporting IND filings
• Manage budgets and headcounts
• Design, implement and manage externally facing in vivo studies with CROs and academic centers, including drafting proposals, budget oversight and managing deliverables
• Resource planning; hiring and mentoring talents; building the team and technical capabilities
• Build collaborations with relevant functions at 4DMT; represent own function at the corporate level and externally
• Direct and oversee all Translational interactions as well as grant writing and management with rare disease advocacy groups
• Support regulatory affairs in their preparation, review and submission of necessary pre-clinical and clinical regulatory information to regulatory agencies worldwide
• Contribute to defining of clear human POC study outcome criteria for decision-making on new product candidates
• Contribute senior level expertise to alliance, business development, due diligence exercises with external entities and licensing meetings as well as other critical external interfaces such as public health regulatory bodies
• Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time

Qualifications

• PhD, MD/PhD, MD or equivalent
• 12+ years of relevant preclinical and/or translational sciences experience within the Biotech or similar industry
• 4+ years of management experience or other specific work experience
• Experience with preclinical, translational, and clinical R&D
• Prior leadership position/s within the pharmaceutical/biotech industry or academic medical centers, with a significant history of research and translational experience
• Reputation for inspiring a culture of continuous improvement, innovation and quality, leading and mentoring at the highest level of achievement

Skills

• Team leadership skills and experience in a matrixed organization
• Ability to support and impact experts, scientists and project deliverables across functions in research, development and beyond
• Strong communication skills both written and oral with demonstrated ability to present ideas, information, and data effectively via one-on-one discussions, team meetings, and presentations to executive leadership
• Excellent time management skills (schedules, timelines, task prioritization) and the ability to adapt to changing priorities
• Self-starter who proactively establishes effective working relationships and builds partnerships with other disciplines
• Adaptability, flexibility, independence and resourcefulness; as an active participant in a vibrant small company culture, rolls up sleeves and manages multiple activities in parallel.
• Ability to proactively identify challenges; possesses strategic foresight and implements appropriate courses of action
• Excellent verbal and written communication skills

Physical Requirements And Working Conditions

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.
• Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.
• Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).