The Senior Director will drive the translational strategy and early clinical development for products in the Acadia portfolio. The role involves drug development across multiple disease areas in neuroscience. It will contribute to the global early development programs, with primary responsibility for designing, planning, and executing phase I studies and supporting late phase development (Phases II-IV), leading clinical pharmacology aspects of IND, NDA/MAA/NDS submissions, and advisory boards. The individual will contribute to and lead multi-disciplinary, cross-functional teams through complex decisions integrating input from medical, scientific, regulatory and commercial perspectives. They will contribute to developing innovative physiologically-based Pharmacodynamic and PK/PD models that best characterize key compound attributes and allow for differentiation from other products in the same class. The individual will also participate in the evaluation of licensing opportunities and assessment of their compatibility with the existing portfolio.
- Establishes strategic plans for designated products/programs and participates with senior management to align objectives across the organization; develops methods, techniques, and evaluation criteria for projects and programs.
- Conceptualizing and planning all scientific aspects of early clinical development trials
- For early development/Phase I studies:
- Implements study designs and protocol development
- Oversees clinical conduct and provides medical oversight
- Oversees data analysis and reporting
- Support late-stage development, including the development of appropriate clinical pharmacology sections and reviewing protocols and reports for Phase II-IV studies as needed.
- Contributes to the design, development, and interpretation of target engagement, proof-of-principle, proof-of-mechanism, and PK/PD models, as appropriate
- Contributes to the evaluation of business development opportunities; may serve as a clinical point of contact for ongoing alliance projects.
- Ensures compliance with appropriate SOP’s GCP, and ICH guidelines for all Clinical Pharmacology-related studies.
- Serves as key early clinical development voice for both internally and externally facing stakeholders
- Interfaces with regulatory authorities, as appropriate, in support of development objectives
- Acquires and maintains knowledge of national and international guidelines, including industry standards for Good Clinical Practice
- Minimum of an MD, equivalent education, and experience may be considered
- An additional degree in basic sciences is a plus (MSc, Ph.D.)
- Minimum of 10 years of hands-on experience in Clinical Pharmacology, Experimental Medicine, and Translational Research in CNS disorders including a minimum of 5 years in a leadership role.
- Experience planning and implementing development studies including first-in-human, proof-of-mechanism pharmacodynamic studies, and proof of concept studies
- Direct experience and responsibilities in regulatory interactions, including IND opening and CTA submissions
- Experience with diverse phase II study designs
- Experience in the compound development strategy in multiple psychiatric and neurological indications
- General knowledge and understanding of clinical pharmacology principles applied to early development studies and biostatistics.
- Excellent interpersonal communication and networking skills with the ability to build cross-functional bridges.
- Skilled at negotiating with business partners or management and influencing senior-level leaders regarding matters of significance to the organization
- Proficient at crafting and communicating a clear vision among team members to align resources and activities to achieve functional area and/or organizational goals.
- Experience working with commercial organizations (e.g., US and global commercial, early commercial strategy) but not vital
- Must reside in the United States
Establishes strategic plans for designated function(s) and participates with others in management to align objectives across the organization. Develops methods, techniques, and evaluation criteria for projects, programs, and people. Works on complex issues where analysis of situations or data requires an in-depth knowledge of the functional area and related organizational objectives. Erroneous decisions will seriously impact the overall success of the functional area and may impact the company's long-term success.
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. The employee must occasionally lift and/or move up to 15 pounds. Ability to travel by car or airplane independently up to 25% of the time and work after hours if required by travel schedule or business issues.
ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity