(Senior) Director Clinical Research

Position Summary

The (Senior) Director, Clinical Research will lead clinical programs for rare diseases and/or neurologic and neuropsychiatric disorders. This role requires extensive clinical and scientific knowledge and a strong network in the medical community.

Primary Responsibilities

• Create and execute global clinical development plans consistent with the Company’s strategic vision and mission.
• Ensure the optimal planning, implementation and interpretation of clinical studies, including synopsis/protocol development, medical monitoring, data analysis and writing of final reports.
• Maintain and build productive relationships with investigators, thought leaders and centers of excellence across the scientific community, as well as with colleagues across the Acadia organization.
• Interact frequently with sites to support study awareness, patient recruitment, and quality of study conduct.
• Communicate appropriate program issues and results to key internal and external stakeholders.
• Support regulatory interactions, including the submission of regulatory documents and presentations.
• Provide clear and insightful clinical and scientific expertise to advance the successful transition of compounds from discovery to full development, and subsequently to life cycle management.
• Review business development opportunities, translating business needs to cost-effective development strategies that provide a competitive advantage and meet regulatory requirements.
• Comply with current local and international regulations, laws, scientific and regulatory guidance, Good Clinical Practices, and Acadia’s policies and procedures.
• Other duties as assigned.

Education and Experience

• MD or equivalent required; Board Certified/Eligible strongly preferred.
• Targeting 3-5 years of relevant medical/clinical practice, related research, or academic experience within the pharmaceutical industry.
• Ideal candidate will have experience with medical monitoring, including clinical research, creating and implementing development plans and clinical studies.

Key Skills

• Applicable industry experience across several phases of development is strongly desired.
• Established relationships with thought leaders and investigators in depression and other mood disorders.
• Experience in rare disease and/or neurology strongly preferred.
• Demonstrated leadership to work well within a geographically diverse cross-functional team environment.
• Ability to work within a growing organization within the U.S. and to help the organization evolve over time into the world leader in rare diseases and neurologic and neuropsychiatric disorders.
• Experience interacting with senior leaders, including global regulatory agencies.
• Excellent verbal and written communication skills as well as interpersonal, management, and organizational skills.
• Demonstrated problem solving abilities and conflict resolution skills.
• Ability to engage in an open, constructive and continuous dialogue with the Company’s stakeholders.
• Highly motivated, self-driven and dependable.
• Willing and able to travel both domestically and internationally.

Physical Requirements

• Regular standing, walking, sitting, and the use of hands for handling or operating equipment.
• Occasional lifting and/or moving up to 20 pounds.
• Able to travel independently overnight and/or work after hours as required by travel schedules or business needs.

What we offer US-based Employees

• Competitive base, bonus, new hire and ongoing equity packages.
• Medical, dental, and vision insurance.
• Employer-paid life, disability, business travel and EAP coverage.
• 401(k) Plan with a fully vested company match 1:1 up to 5%.
• Employee Stock Purchase Plan with a 2-year purchase price lock-in.
• 15+ vacation days.
• 13 -15 paid holidays, including office closure between December 24th and January 1st.
• 10 days of paid sick time.
• Paid parental leave benefit.
• Tuition assistance.

EEO Statement (US-based Employees)

We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.

Additional Information

Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.