Medical Director, Epilepsy

As a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximally improve patients' lives. And at a higher level we share an ambition and a passion to create impactful neuromedicines, with fewer side effects, that allow patients and their families to live healthier and more fulfilling lives.

On a molecular scale, our deep understanding of the intricate relationships between receptors, their associated proteins, and their distributions in specific cell types and brain regions enables us to precisely direct medicines to the neural circuits underlying disease pathophysiology.

Responsibilities:

• Providing clinical leadership and strategic medical input for all clinical deliverables in Rapport's lead program, RAP-219, related to Epilepsy

• Driving execution the assigned clinical program and/or clinical trial in partnership with clinical operations

• Contribute to the development of regulatory documents in support of regulatory submissions, including clinical section of IND's and CTA's, safety reports, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.

• Ensure that scientific rigor and innovation is at the forefront our Rapport's clinical development strategy

• Manage engagements with external organizations, key opinion leaders, and advisors

• Supporting the Head of Clinical Development by providing medical input into Clinical development strategy and protocol reviews

• Work 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

• Establishes strong collaborations with study investigators, outside medical experts and represent Rapport during investigator meetings and advisory boards.

• Serve as the medical monitor for assigned studies including design, execution and interpretation of study data.

Requirements:

• MD or equivalent medical degree is required

• Minimum of 5 years of experience working in the biotech/pharmaceutical industry in clinical research or drug development or as study investigator

• Required advanced knowledge and clinical training and/or drug development experience in Epilepsy

• Proven clinical development strategist with hands-on experience with designing, implementing, and conducting clinical trials in Epilepsy, 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 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 and demonstrated 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.

Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.

CCPA disclosure notice can be found here.