Associate Director, Clinical Development

The Associate 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 to the CRO and other vendors.  

Responsibilities:

• Serves as a responsible member of the clinical 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
• 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  
• Monitors patient data and study-related information related to clinical study sites and clinical trial participation, including data science approaches
• Provides timely and accurate monitoring of patient data and study-related information from source documents, research records, and site visits where applicable. May monitor study sites and audit facility selection, blinded data monitoring
• Liaises with statisticians and programmers to help develop and implement the statistical data analysis plans
• 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 
• 3+ 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 $169,814.00 - $$192,241.00. 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!