Provides clinical science leadership within assigned teams or programs
Manage the design, planning and execution of clinical trial program(s) as needed with minimal guidance
Is able to play a leadership role in subject matter expertise when interacting with global health authorities
Has deep familiarity with registration submission strategies and can manage the Clinical needs for all submissions as needed
Leads the study design, implementation and execution of clinical trials on assigned programs. Is responsible for the preparation of clinical study synopses and serves as a major contributor to the writing of protocols/major amendments, the design of data collection systems, the interpretation of clinical data, and the preparation of final clinical study reports
Works cooperatively with project team members to provide clinical development expertise and leadership
Responsible for identifying and cultivating relationships with relevant national and international thought leaders to further project goals
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
Responsible for providing or supervising medical monitoring activities for all human clinical trials including support of adverse event reporting and safety management
Responsible for ongoing benefit/risk assessment, monitoring adherence to protocols, helping in the investigation of protocol deviations and providing leadership for monitoring activities related to execution of the protocol or program
Provides medical/clinical information for inclusion in reports submitted to regulatory authorities and supports the authoring of regulatory documents
Develops relationships with investigators and external organizations and experts to optimize study design and executions
Requirements
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6+ years of relevant clinical development experience
Experience in CNS development (Psychiatry or neurology) strongly preferred
Possess strong knowledge of the clinical development process
Possess a solid understanding of the pharmaceutical industry, company competition and commercial side of business
Experience in small molecule development
Experienced in data review and analysis, presentations (internal and external) and regulatory writing (IND, CTD sections)
Experience building strong relationships within cross-functional groups to achieve results
Proven ability to identify and solve relevant problems related to clinical development
Experience in clinical research for psychiatry, addiction psychiatry, and addiction medicine programs, strongly preferred.
Background and proven relevant experience in engaging with clinical trial strategy and trial management
Understanding of the drug development process including technical, business, and regulatory issues.
IND experience strongly preferred
Diplomacy and professionalism, ability to build positive relationships both with company leadership and external experts
Able to command respect from peers and subordinates, capable of highly independent work as well as being a team player and role model
Excellent interpersonal, verbal and written communication skills
Proven ability to work remotely and with remote internal and external interdisciplinary teams
Problem-solving and strategic planning skills
Excited by innovative ideas in clinical research space
Self-motivated, resourceful with a ‘get the job done’ attitude in a fast-paced team environment
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 $247,649.00 - $298,800.00. 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 vesting after the turn of the first month after your start date
Flexible time off
Generous parental leave and some fun fringe perks!
