The Sr. Director, Clinical Development will play a key role in the design and execution of ongoing and new clinical studies and contribute to the clinical development plan for one or more programs. The position will successfully lead and/or serve as the clinical science representative on 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 successful candidate will have direct and recent experience in late phase clinical development, and in CRO and KOL interactions.
Responsibilities:
• Provides clinical science leadership within assigned teams or programs • Manages 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, oversees and ensures the quality, coordination and timeliness of clinical sections of INDs, Investigator Brochures, CTAs, ISS, ISEs 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:
• Doctoral level degree (PhD, MD, PharmD, PsyD) required • 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) • Experienced in 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
Compensation:
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