(Senior) Director, Translational Medicine and Diagnostics

About the role

In this pivotal position, you will spearhead translational medicine initiatives across various therapeutic domains, guiding projects from their early development stages to clinical proof-of-concept. Your leadership will be crucial in integrating artificial intelligence and machine learning methodologies to enhance the efficiency of clinical trials and ultimately improve patient outcomes. This role presents an exceptional opportunity to make a significant impact on the future of drug development and patient care.

Key facts

What you'll do

• Lead the establishment and management of the translational medicine function, overseeing projects from Investigational New Drug (IND) or Clinical Trial Application (CTA) submissions through to clinical proof-of-concept for various therapeutic modalities, including biologics, oligonucleotides, and small molecules.
• Serve as the translational lead for advanced preclinical and early clinical development assets, ensuring alignment with strategic goals.
• Direct the overall translational medicine strategy, maintaining compliance with Good Clinical Practice (GCP) and managing relationships with regulatory bodies, including the selection and oversight of biospecimen contract research organizations (CROs).
• Innovate patient stratification techniques utilizing both laboratory and digital biomarkers to enhance clinical trial design and outcomes.
• Generate compelling evidence of the mechanism of action for therapeutic candidates to facilitate objective, data-driven decision-making processes.
• Analyze and interpret regulatory requirements pertinent to translational medicine, evaluating the effectiveness of various translational strategies.
• Collaborate effectively with cross-functional teams, including preclinical, clinical, regulatory, and computational experts, to drive project success.
• Advocate for the integration of AI and machine learning policies in translational science through scholarly publications, presentations, and active engagement with industry stakeholders.

Requirements

• An advanced degree in life sciences, technology, chemistry, or a related discipline, or equivalent practical experience in the field.
• A minimum of 10 years of experience in translational science within the biotechnology or pharmaceutical sectors.
• Proven track record as a translational lead, successfully guiding therapeutics and diagnostic biomarkers through the entire lifecycle from first-in-human studies to proof-of-concept and subsequent NDA/BLA submissions.
• Familiarity with applying AI and machine learning techniques to enhance drug discovery and development processes.
• In-depth knowledge of diagnostic and device regulations, GCP, clinical trial design and execution, clinical pharmacology, biostatistics, and the computational aspects of drug development.
• Exceptional communication and collaboration skills, with the ability to engage effectively with a diverse range of stakeholders across clinical, translational, computational, and life sciences domains.
• Strong interpersonal abilities that motivate and inspire team members to achieve common goals.
• A genuine commitment to advancing the development of improved therapeutic options for patients.

Nice to have

• Experience in leading cross-functional teams in a fast-paced, dynamic environment.
• Familiarity with the latest advancements in biomarker discovery and validation.
• Previous involvement in regulatory submissions and interactions with health authorities.

Skills & tools

• Proficient in utilizing advanced data analytics and visualization tools to interpret complex datasets.
• Familiarity with electronic lab notebooks and other laboratory management systems.
• Experience with project management software to track progress and ensure timely delivery of milestones.

Practical notes

Travel: Occasional travel is required for participation in relevant medical and translational science conferences, as well as meetings with health authorities.

Benefits: Comprehensive benefits package including a 401(k) plan with employer matching, medical, dental, vision, and mental health coverage, flexible vacation policies, paid parental leave (16 weeks for birth parents, 10 weeks for other new parents), a quarterly budget for professional development, a stipend for home office setup, a monthly allowance for cell phone and internet expenses, onsite baristas, daily lunch for onsite/hybrid employees, and a commuter bus network.

Application: Please be cautious of recruitment scams; all official communications will originate from @insitro.com.