VP/SVP, Clinical Development, CNS

Why this role matters:

As the Head of Clinical Development, you will play a crucial role in shaping and executing all of our clinical strategies that drive the development of novel therapies to treat patients with CNS conditions, including epilepsy, neuropathic pain, and bipolar disorder. This position offers a unique opportunity to make a significant impact on the lives of these patients by advancing innovative treatments in areas of critical medical need, working with passionate CNS medical scientist colleagues.

Your day-to-day:

• Establish the clinical development strategy and hands-on tactical execution plans against the current and future development portfolio.
• Manage effective internal and external relationships, such internally  with members of the executive leadership team, regulatory affairs, clinical operations and medical affairs, and externally including regulatory agencies, partners, KOLs, and investigators.
• Medical oversight of ongoing clinical trials.
• Lead clinical sections of regulatory documents (IND, BLA/NDA).
• Work with Regulatory Affairs to prepare for meetings with FDA and healthcare authorities.
• Work with Medical Affairs to organize and prepare for advisory board meetings.
• Prioritize and develop the company’s current drug candidates as well as future pipeline compounds and contribute to go / no-go decisions.
• Literature review, KOL interactions, attending scientific meetings, and presenting the clinical development plan to the relevant internal stakeholders to help shape the new indication selection process.
• Ensure that standard operating procedures (SOP) for Clinical Development facilitate the development of effective clinical research protocols and are compliant with clinical/medical and industry standards.
• Actively participate in strategic planning for the clinical development organization and provide support to business development / licensing activities.
• Maintain an understanding of competitors and clinical developments in relevant therapeutic areas.
• Build and maintain medical advisory boards based on solid working relationships with KOLs and lead clinical investigators.
• Build and lead a team, creating an environment where team members thrive and deliver outstanding results.

Must-haves:

• MD required, training in neuroscience or neurology required
• Experience in Epilepsy, Bipolar Disorder or Neuropathic Pain required 
• 15+ years of global clinical development experience leading the clinical development strategy in a biotech or pharmaceutical company
  • VP or SVP title commensurate with relevant experience 
• 5-10+ years experience managing teams preferred
• Demonstrated ability to attract talent, lead, inspire, and grow and develop teams
• Track record of innovative, strategic leadership, and flawless execution in the field of neurological and/or neuropsychiatry drug development.
• Experience with GCP/ICH/FDA requirements, clinical trial design and strategies, interpretation of clinical data and generation of supporting regulatory submissions of clinical study documents.
• An ability to work in our Boston, MA office 1-2 days a week
• Success leading the design and execution of effective clinical development strategy.
• Exceptional interpersonal, influencing, presentation, and written and verbal communication skills.
• Experience with successful NDA submissions and approvals and interactions with regulatory agencies are highly desired.
• Understanding of the general healthcare environment laws, regulations, and evolving market access trends and issues.
• Knowledge and experience of building clinical development infrastructure as organizations grow.

What makes working here dino-mite:

• 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.

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 this role to be $320,000 to $380,000. 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.