Director, Clinical Development

Summary

Join MindMed, a clinical-stage biopharmaceutical company, as the Director, Clinical Development. You will play a key role in designing and executing clinical studies, serving as the clinical science representative for one or more studies. This position requires collaboration with various stakeholders to deliver high-quality data for registration and launch. You will lead clinical science efforts with CROs and vendors, ensuring alignment with company goals and regulatory requirements. The ideal candidate possesses a doctoral degree, extensive clinical development experience, and strong knowledge of the pharmaceutical industry. MindMed offers competitive compensation and benefits, including 100% paid health benefits, a 401(k) program, flexible time off, and generous parental leave.

Requirements

• Doctoral level degree (PhD, MD, PharmD, PsyD) required
• 4+ years of clinical development experience
• 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 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
• Excellent writing and communication skills
• Ability to travel as required, including international travel. Average 10-20%, reaching 50% or more in some months

Responsibilities

• Serve as a team leader and/or as the clinical representative to a global development team
• Work cooperatively with project team members to provide clinical development expertise and leadership
• Provide 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
• Write and edit 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

• Experience in CNS development (Psychiatry or neurology) strongly preferred
• Experience in small molecule development and ideally registration
• 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
• Employees in this role may be entitled to additional compensation, including bonus and equity