Your impact: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 Bipolar Mania 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.
Your day-to-day: - Provision of medical input for all clinical deliverables in Rapport's lead program, RAP-219, related to Bipolar Mania
- 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
Must-Haves:- 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 Psychiatry
- Proven clinical development strategist with hands-on experience of designing, implementing, and conducting clinical trials in neurology, Phase 2a - Phase 3
- Working knowledge of psychiatry indications 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
What makes Rapport special:- Every role has meaning. We're determined to discover a better way for patients, and you'll feel the passion from the start.
- We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
- Your perspective matters. Stick your neck out, share your ideas - we work as a team.
- We have FUN. We hire smart, dedicated, down-to-earth people that you'll enjoy spending time with.
- Leadership that CARES - about you, your growth + development.
- We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston - we make the most of our time together.
- Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
- You get to be YOU! Show up as you are and make every day count.
Your Compensation:We get it. Compensation is an important part of your offer. You shouldn't be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this? We tell you about our hiring range now - we expect the hiring range for the role to be $285,000 to $350,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don't stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company.
Hybrid Work Environment:We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday-Wednesday to create more opportunities for innovation, collaboration, and connection.
