Remote Director Clinical Development

Summary

Join MindMed as Director, Clinical Development to play a key role in the design and execution of ongoing and new development clinical studies. This position serves as the clinical science representative for one or more clinical studies (US and/or global) to deliver high quality data for registration.

Requirements

• Doctoral level degree (PhD, MD, PharmD, PsyD) required
• 4+ years of clinical development experience
• Experience in CNS development (Psychiatry or neurology) strongly preferred
• Possess strong knowledge of the late-stage clinical development process
• Possess a solid understanding of the pharmaceutical industry, company competition and commercial side of business
• Experience in small molecule development and ideally registration
• Experienced in data review and analysis, presentations (internal and external) and regulatory writing (IND, CTD sections)
• Experience building strong relationships within the group (Clinical Operations, Regulatory, Product Development) and across functional groups (Medical Affairs, Commercial) to achieve results

Responsibilities

• Serves as a team leader and/or as the clinical representative to a global development team
• Works cooperatively with project team members to provide clinical development expertise and leadership
• Providing therapy area medical and scientific expertise in evaluation and presentation of data and trial results, including advanced skills with relevant programs including at minimum Microsoft Excel and PowerPoint
• Writing and editing of clinical study protocols, clinical study reports, manuscripts, and other study-related documents
• In partnership with Regulatory Affairs and Project Management, oversee and ensure the quality, coordination and timeliness of clinical sections of IND's, Investigator Brochures, CTA's, ISS', ISE's and clinical expert reports, including writing and editing
• Work with partners to assure that the strategic positioning is in line with company goals and regulatory requirements
• Work with Medical Writing to prepare abstracts, manuscripts and presentations for external meetings
• Create an atmosphere of innovation and continual improvement
• Any additional responsibilities assigned by the leadership

Preferred Qualifications

• Excellent writing and communication skills
• Managerial skills a plus
• Ability to handle obstacles and roadblocks by anticipating challenges and preparing well thought out arguments and contingencies
• Proven track record of garnering support for projects and recommendations through on-going collaboration, open and influential communications and commitment to improvement/change

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and immediate vesting
• Flexible time off
• Generous parental leave and some fun fringe perks!