Our client is an innovative biotech startup focused on developing a groundbreaking gene therapy platform that uses a unique non-viral approach. The Senior Director, In Vivo Pharmacology, will be a pivotal member of the research team, responsible for designing, implementing, and overseeing in vivo studies that support the company's gene therapy pipeline. This role requires leading the in vivo research team, collaborating with various cross-functional partners, and guiding studies that will play a critical role in developing new therapies and advancing them toward FDA Investigational New Drug (IND) applications. This is an on-site position.
Key Responsibilities:
Lead the innovation and execution of preclinical studies that advance the development of gene therapy drug candidates.
Oversee the design, implementation, and analysis of in vivo pharmacology experiments to support research and development goals.
Develop and refine research strategies to align with the company's goals, focusing on platform enhancement and preclinical validation.
Identify and collaborate with external research partners, including contract research organizations (CROs), to generate key pharmacokinetic and efficacy data.
Drive the exploration of new methods for preclinical and clinical biomarker identification.
Facilitate strong communication and knowledge-sharing across internal teams and external stakeholders.
Present research plans, findings, and strategies to internal teams and senior management to support decision-making.
Lead efforts in preparing regulatory submissions, including IND and other relevant documents.
Cultivate a team-oriented culture that values openness, career growth, and scientific excellence.
Qualifications:
PhD or MD in a relevant scientific discipline such as Molecular Biology, Genetics, Immunology, or Biochemistry.
At least 15 years of experience in designing and managing in vivo pharmacology studies, particularly within the biotech or pharmaceutical industry.
Proven track record in leading in vivo research projects, with hands-on experience in both non-GLP and GLP study management.
Extensive background in gene therapy or related fields, with experience in early-stage biotech environments preferred.
Strong leadership skills with a minimum of 10 years of experience managing scientific teams and complex cross-functional projects.
Familiarity with pre-IND regulatory processes and experience in creating comprehensive study reports for submission.
Technical Skills:
Expertise in in vivo study designs and techniques, including imaging and various disease models.
Ability to think strategically, analyze risk, and develop innovative solutions in the field of gene therapy.
Excellent communication skills, with a focus on building collaborative scientific teams and external partnerships.
Capacity to manage multiple projects in a fast-paced, dynamic work environment while staying current on industry trends.