Director, Clinical Development

MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health.

Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team of patient-centric, intelligent individuals.

The Director, Clinical Development will 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. The position requires the ability to partner with Clinical Operations, Clinical Pharmacology, Regulatory, Early Development, Medical Affairs, Commercial and other stakeholders to deliver clinical programs for registration and launch. The Director, Clinical Development will act as the clinical science lead in with the CRO and other vendors.

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

Qualifications:

• 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

Other Skills:

• 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

Special Working Conditions:

• Ability to travel as required, including international travel. Average 10-20%, reaching 50% or more in some months

The starting base pay range for this position is $171,000.00 - $269,304.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.

Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:

• 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!

Originally posted on Himalayas