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. Candidates should have a PhD or MD/PhD degree (or equivalent) in Biological Sciences or a related discipline, with significant experience in pharmaceutical research and development.  They will lead a preclinical and translational group responsible for: (1) developing target-engagement biomarkers and clinical biomarkers with relevance to Proof of Concept (POC) gene therapy studies, (2) conducting laboratory and in silico analyses of biomarker readouts generated in the relevant Phase 1 and Phase 2 gene therapy studies, (3) performing immunological assays and analyses relevant to detecting host immune responses to 4DMT gene therapy vectors in the clinical trial setting, and (4) overseeing outsourced performance of preclinical pharmacology and toxicology studies of 4DMT gene therapy vectors, in partnership with external CROs. This role will interact and collaborate with multiple functions at 4DMT, including but not limited to Clinical Science and Operations, Regulatory Affairs, Discovery & Innovation, Commercial, and CMC.

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
• Provide direct hands-on responsibility for all Translational interactions as well as grant writing and management with rare disease advocacy groups
• Participate on project teams and direct activities to ensure regulatory compliance of pre-clinical and clinical research activities
• 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: 

Education:

• PhD, MD/PhD, MD or equivalent

Experience:

• 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

Travel: 5-10%

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. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $270,000 - 342,000

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.