Clinical Scientist (Director/Senior Director)

Affinia Therapeutics; Waltham (MA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Bonus

Equity

Competitive benefits

Job summary

Affinia Therapeutics is seeking a Clinical Scientist (Director/Senior Director) to lead the clinical development plan for its gene therapy program in BAG3-associated dilated cardiomyopathy. Join a cross-functional team to execute trials, author regulatory documents, and interact with external investigators.

The role emphasizes start-up and execution of early-phase studies, safety monitoring, and collaboration with leadership to drive regulatory strategy and scientific communication.

Qualifications

• 7+ years in pharma/biotech industry or equivalent clinical research experience.
• Experience in start-up, execution and close-out of clinical trials.
• Knowledge of cardiovascular or rare disease trials; gene therapy knowledge preferred.
• Experience authoring protocols and regulatory documents for US and major ex-US jurisdictions.

Responsibilities

• Drive deliverables for First-in-Human Phase 1b/Phase 2 trial for AFTX-201.
• Contribute to protocol development and amendments; prepare consent forms and regulatory documents.
• Support CROs, investigators and site personnel; ensure timely regulatory responses and patient safety.
• Oversee safety monitoring: AE/SAE reviews, listings, and data integrity.
• Review efficacy data; assist in data interpretation and regulatory output.
• Collaborate with Clinical Leader on regulatory interactions and advisory boards.
• Develop external medical communication strategies; support abstracts and manuscripts.

Skills

Clinical trial leadership

Regulatory writing

Biostatistics & analysis

GCP compliance

Cross-functional collaboration

Education

Advanced degree (PhD/PharmD/NP/MA/MS/MPH)

Job description

Affinia Therapeutics is an innovative biotech company developing next generation gene therapies. We have a series of transformational next generation AAV capsids that we are leveraging to develop differentiated first in class and best in class gene therapies for cardiovascular and neurological diseases. Our initial focus is on helping patients with BAG3-associated dilated cardiomyopathy, a devastating genetic heart disease. We are backed by a strong syndicate of life science investors and strategic partner Eli Lilly and have ambitious plans to dramatically impact the lives of patients around the world. The executive leadership team has a successful track record of success of drug approvals and company build.

Position Summary Clinical Scientist (Director/Senior Director)

The Clinical Scientist at Affinia Therapeutics has the potential to make a meaningful difference in the lives of people affected by devastating illnesses. The Clinical Scientist is a Director/Senior Director who will help execute the clinical development plan for Affinia Therapeutic’s rare inherited cardiomyopathy gene therapy program. The successful candidate will have experience in start-up, execution and close-out of clinical trials and will be a key partner to the Clinical Leader and to Clinical Operations in executing Affinia Therapeutic’s First-in-Human Phase 1b/Phase 2 clinical trial for AFTX-201. Ability to work within cross functional teams is a must.

Primary Responsibilities

• Drive deliverables for the First-in-Human Phase 1b/Phase 2 clinical trial for AFTX-201, Affinia Therapeutic’s lead program in BAG3 associated dilated cardiomyopathy.
• Contribute to protocol development, protocol amendments, and development of and amendments to informed consent forms, patient recruitment materials, Investigator’s Brochures, manuals and training documents, and other clinical and regulatory documents for U.S. and major ex-U.S. jurisdictions;
• Assist in answering questions from CROs, investigators and other site personnel regarding clinical and study conduct questions to help ensure timely regulatory responses from institutional IBC and IRB as well as patient safety and maintenance of appropriate adherence to the protocol;
• Conduct safety monitoring of the clinical trial in collaboration with the Clinical Leader by reviewing AE reports, SAE reports, SAE listing, medical coding, tables, listings and other relevant output from the clinical study;
• Review medical efficacy data in collaboration with the Clinical Leader by reviewing relevant tables, listings and figures and other output from the clinical study as well as reviewing data integrity;
• Contribute to the design and execution of activities conducted in support of the clinical program e.g., regulatory interactions, DSMB interactions, advisory boards.
• Cultivate relationships with external partners such as clinical investigators and key opinion leaders.
• Develop the external medical communication strategy in collaboration with internal functional leads and contribute to the preparation and presentation of abstracts, posters, and manuscripts.
• Clinical or scientific advanced degree (e.g., PhD, PharmD, NP, MA/MS/MPH); equivalent combination of relevant education and experience may also be considered.
• Minimum of 7 years of relevant pharma/biotech industry experience OR relevant equivalent clinical research experience including study level experience and protocol development.
• Knowledge of cardiovascular, or rare disease clinical trials desirable. Experience in gene therapy is preferred.
• Experience with authoring protocols and other clinical study related documents and the preparation of regulatory documents in U.S. and major ex-U.S. jurisdictions.
• Experience in study start-up, patient recruitment, study conduct, data analysis and interpretation (safety and efficacy) and a strong working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
• Ability to work collaboratively in a fast-paced, team-based environment
• Excellent written and verbal communication skills
• Intellectual curiosity, flexibility, and persistence
• High level of organizational and project management skills
• Outstanding attention to detail

The role is based in the Waltham, MA office with at least 4 days per week in the office

Travel up to 10%: field sites, internal and external meetings and conferences, as needed

• Plus- level appropriate bonus, equity and competitive benefits

EEO Statement: Affinia Therapeutics is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.