Head of Clinical Research, Metabolic Diseases Somerville, Massachusetts, United States

Head of Clinical Research, Metabolic Diseases

Somerville, Massachusetts, United States

Minimum Qualifications:

• MD/PhD or equivalent degree with relevant internal medicine training and board certification +15 years of industry experience in clinical development within a pharmaceutical or biotechnology company.
• Designing, implementing, and overseeing multiple early-stage clinical studies, including study start-up activities, medical monitoring and productive partnership with study investigators and clinical research organization staff.
• Authoring documents required for clinical studies, including study protocols, investigator brochures, regulatory briefing packages and dossiers to support IND/CTA/CTN. You must have direct experience with IND/CTA submissions.
• Thorough understanding of ICH and GCP guidelines to ensure the appropriate conduct of global clinical studies.
• Understanding of clinical research methodology and biostatistics principles.
• Demonstrated track record of overseeing a clinical team and successfully completing clinical studies.
• Effective communication and presentation skills.

You are interested in:

• Providing clinical leadership and medical representation for the liver GeneWriting TM programs, serving as primary medical lead/expert and medical monitor for clinical studies.
• Ensuring a streamlined and innovative clinical development and medical strategy by developing expertise in relevant therapeutics areas and staying current with advances in the field.
• Authoring medical components for clinical development plans, study protocols, investigator brochures, informed consents, SAPs, pharmacy manuals and associated clinical/regulatory documents including clinical study reports, regulatory briefing books and submissions.
• Hiring, developing and managing clinical development resources in accordance with program budget and timelines.
• Overseeing risk-based safety monitoring of clinical studies, including regular review of safety data.
• Interpretation and analysis of clinical study safety and efficacy data, as well as reviewing nonclinical toxicology studies.
• Preparation of meeting abstracts, posters, presentations, and publications for internal management review and external scientific/clinical meetings.
• Maintaining a constant focus on patient wellbeing across the organization.

About you:

You are an industry experienced physician trained in internal medicine who is interested in leading Clinical Development of Tessera’s non-viral lipid nanoparticle (LNP) delivery and Gene Writing TM genome editing platforms to correct pathogenic mutations in the liver. You have experience with strategic oversight, hands-on management and advancement of innovative clinical stage programs.

You encompass skill and drive to be hands on and are interested in building a team from the group up. You have the ability to create strong collaborations across leadership and key stakeholders while representing the medical perspective for Tessera’s programs both internally and externally.

Tessera leaders are empathetic and transparent coaches with a strong sense of integrity. They are committed to the growth and development of their teams, the organization and themselves.

Company Summary:

Tessera Therapeutics is pioneering Gene Writing— a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy.

More about Tessera Therapeutics:

Tessera is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, marital status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate.