(Senior) Medical Director, Medical Science

Rapport Therapeutics•Boston, MA

2d•$250,000 - $295,000•Hybrid

About The Position

This Medical Director role offers the opportunity to partner closely with cross-functional leaders to support both clinical development and strategic initiatives in support of the RAP-219 Epilepsy program. The position provides broad exposure to multiple programs, with the chance to work hands-on in the details while growing within a fast-paced, innovative organization.

Requirements

MD or equivalent medical degree is required
Minimum of 2 years’ experience working in the biotech/pharmaceutical industry in clinical research or drug development
Strongly preferred advanced knowledge and clinical training and/or drug development experience in Neurology
Proven clinical development strategist with hands-on experience of designing, implementing, and conducting clinical trials in neurology, Phase 2a – Phase 3
Working knowledge of epilepsy is required, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research reports
Demonstrated ability to assimilate clinical data, perform thorough analysis and review, make crisp assessments, and communicate effectively both verbally and in writing
Demonstrated ability to establish effective scientific partnerships with key stakeholders
Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
Experience authoring regulatory documents, specifically exposure to the IND/NDA/BLA approval process
Ability to communicate and work both independently and collaboratively with colleagues across disciplines
Excellent oral presentation skills
Ability to think critically with demonstrable troubleshooting and problem-solving skills
Comfortable in a fast-paced small startup environment with minimal direction and able to adjust workload based upon changing priorities
Demonstrated ability to work effectively either independently or collaboratively in a cross-functional team environment, as well as with external colleagues.
Strong organizational, project management and leadership skills
Experience working cross-functionally, including consulting with key business stakeholders with an ability to influence for greater outcomes
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
Possesses strong written and verbal communication skills

Responsibilities

Provision of medical input for all clinical deliverables in Rapport’s lead program, RAP-219, related to epilepsy
Driving execution of the assigned clinical program and/or clinical trial in partnership with clinical operations
Contributing to the development of regulatory documents in support of regulatory submissions, including the clinical sections of INDs and CTAs, safety reports, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
Ensuring that scientific rigor and innovation is at the forefront our Rapport’s clinical development strategy and implementation
Managing engagements with external organizations, key opinion leaders, and advisors
Supporting medical input into clinical development strategy and protocol reviews
Working closely with functional partners (Clinical Operations, Data Management, Biostatistics, Regulatory, Medical Affairs) to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocols
Establishing strong collaborations with study investigators and outside medical experts and representing Rapport during investigator meetings and advisory boards
Serving as the medical monitor for assigned studies including design, execution, cleaning, and interpretation of study data