Medical Director/Senior Medical Director, Metabolic Diseases

Tessera Therapeutics; Somerville (MA); On-site; USD 200,000 - 300,000; Full time

Job summary

A leading biotechnology company seeks a Medical Director/Senior Medical Director for Metabolic Diseases, requiring extensive experience in clinical development and leadership. This role involves designing studies, medical monitoring, and collaborating with cross-functional teams to drive innovative programs forward, particularly focusing on liver gene therapies.

Benefits

Comprehensive benefits program

401(k) with company contribution

Tuition reimbursement

Qualifications

• Experience with IND/CTA submissions critical for this role.
• Must possess a thorough understanding of ICH and GCP guidelines.
• Necessary skills include effective communication and extensive industry experience.

Responsibilities

• Design and oversee early-stage clinical studies.
• Lead medical representation for clinical development programs.
• Manage clinical development resources per budget and timelines.

Skills

Clinical Development

Leadership

Communication

Medical Monitoring

Regulatory Knowledge

Education

MD/PhD or equivalent

Job description

Medical Director/Senior Medical Director, Metabolic Diseases

Somerville, Massachusetts, United States

• 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 p rograms, 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. This includes soliciting and incorporating input from academic thought leads, research leads, regulatory authorities and CRO’s.
• 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, responses to questions from regulators, IRBs/ECs, and medical content for other relevant internal/external documents.
• 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. Developing appropriate responses to safety issues that might arise.
• 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 n anoparticle (LNP) delivery and Gene Writing TM genome editing platforms to correct pathogenic mutation s 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 st akeholders 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.

Gene Writing to correct monogenic diseases resulting from hepatocyte dysfunction will enable Tessera to pursue curative therapies for diseases such as alpha-1 antitrypsin deficiency, phenylketonuria, and Wilson’s Disease. On the horizon, hepatocyte Gene WritingTM to correct or introduce genetic polymorphisms associated with negative or positive disease risk, respectively, may enable Tessera to develop therapies for prevalent disorders such as MASH, hyperlipidemia, and obesity.

David joined Tessera in 2021 as Chief Medical and Development Officer. David brings over 20 years of expertise in clinical drug development focused on rare diseases and gene therapy.

Most recently, David served as Chief Medical Officer of bluebird bio for nearly a decade, where he played a critical role in advancing a broad genetic medicine pipeline across blood disorders, rare diseases and oncology, successfully leading numerous genetic medicine programs into the clinic and delivering two first-in-class approvals for genetic medicines in the U.S. and Europe. Prior to bluebird bio, David led clinical research for a wide range of therapeutic programs at Genzyme and GelTex, spanning biologics, polymers, and gene therapy.

David completed a fellowship in infectious diseases at the Harvard Longwood Combined ID Program, his residency training in internal medicine and an endocrinology research fellowship at the University of Chicago Hospitals, and received his M.D. from New York University and B.A. from Columbia University.

Narissa joined the Biotechnology industry shortly after graduating with her BS in Marketing from Franklin Pierce University. She is currently pursuing a MS in Legal Studies from Northeastern University School of Law while working full time as a Manager in Talent Acquisition at Tessera. She is passionate about helping individuals find a fulfilling opportunity while considering their interests, aspirations and technical skills. Narissa lives in Northern Vermont and enjoys spending time outdoors with her husband, three-year-old daughter and German Shepherd.

Tessera offers a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits currently include group medical, vision and dental coverage, group life and disability insurance, 401(k) with company contribution, tuition reimbursement, and much more.

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. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability.

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. Tessera provides reasonable accommodations to qualified applicants and employees with disabilities. To begin an interactive dialogue with Tessera regarding a reasonable accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied, please contact the recruiter or [e-mail]

Recruitment & Staffing Agencies: Tessera Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Tessera Therapeutics or its employees is strictly prohibited unless contacted directly by Tessera Therapeutics’ internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Tessera Therapeutics, and Tessera Therapeutics will not owe any referral or other fees with respect thereto.

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