Clinical Scientist (Director / Senior Director)

Affinia Therapeutics is an innovative gene therapy company with a vision to create a paradigm shift by broadening the reach of gene therapy to prevalent diseases. Our proprietary Affinia Rationally-designed Therapies (ART) platform was created to address key efficacy, safety, and cost of goods limitations of conventional gene therapies. We are backed by a strong syndicate of life science investors. Our purpose is to have a dramatic impact on the lives of patients around the world.

You will play a key role in shaping our culture and embodying our values of integrity, passion, and teamwork. You will be working alongside the management team who has a track record of success in the industry. The pace of work is dynamic, fast, and fun.

We offer a competitive salary and benefits with the ability to make a difference.

Position Summary

The Clinical Scientist at Affinia 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 design and execute the clinical development plan for Affinia's cardiac and neurology gene therapy pipeline. The successful candidate will be adept at developing clinical, regulatory, medical communication, and advocacy strategies and plans in diseases of interest and in executing these plans. The desire to partner closely across internal and external stakeholders and a calling to help patients, initially via clinical trials, is a must.

Primary Responsibilities

• Become an expert regarding scientific advances for the therapeutic and disease area, both internal and external

• Drive deliverables for early clinical development programs such as clinical study design and CRO and trial site identification and preparation

• Cultivate relationships with external partners such as clinical investigators, clinicians, scientists, medical organizations, and patient groups

• Contribute to the design and execution of activities conducted in support of clinical programs e.g., preclinical studies, regulatory interactions, advisory boards

• Contribute to protocol development, protocol monitoring, study reports, training documents, and other clinical and regulatory documents

• Participate on study management and/or clinical development teams to facilitate clinical development goals and achievement of study quality metrics

• Assist in answering questions from CROs, investigators and other site personnel regarding clinical and study conduct questions to help ensure patient safety and maintain appropriate adherence to the protocol

• Participate in the review of SAE reports, SAE listings, medical coding, tables and listings of safety and efficacy data, and other output from clinical studies

• Participate in the development of electronic clinical data case report forms, author medical data review plan, review data integrity and trend, and contribute to study monitoring and data analysis

• Develop the external medical communication strategy and contribute to the preparation and presentation of abstracts, posters, and manuscripts

• Contribute to due diligence when involved in the strategic assessment of new indications to pursue and in in- or out-licensing discussions

Minimum Requirements

• Clinical or scientific advanced degree (e.g., PhD, PharmD, MA/MS/MPH); equivalent combination of relevant education and experience (e.g., hospital pharmacist or registered nurse) may also be considered

• Minimum of 3 -5 years of relevant pharma/biotech industry experience OR relevant equivalent clinical research experience including study level experience and protocol development. Knowledge of gene therapy is an advantage.

• Experience with observational studies, e.g., natural history studies, is preferred

• Knowledge of cardiovascular, neuroscience, or rare disease clinical trials desirable

• Experience with authoring protocols, study start-up, study conduct, data interpretation and the preparation of regulatory documents

• Experience in analysis and interpretation of clinical data (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

• Commitment to patient-focused drug development

• Intellectual curiosity, flexibility, and persistence

• High level of organizational and project management skills

• Experience interacting with development operations (clinical operations, regulatory, QA) and clinical investigators as well as Medical Affairs

• Outstanding attention to detail

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

The role is based in the Waltham, MA office with at least 3 days per week in the office

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.