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 and will contribute to the global early development programs, with primary responsibility for the design, planning and execution of phase I studies and support of 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 the development of 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 participate with senior management to align objectives across the organization; develop 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 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 evaluation of business development opportunities; may serve as clinical point of contract 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
MD degree with a minimum of 12 years of progressively responsible experience in Clinical Pharmacology, Experimental Medicine and/or Translational Research in Central Nervous System disorders in the Pharmaceutical Industry including a minimum of 8 years in a leadership role. Experience in neuropharmacology as it relates to neurologic and/or psychiatric disease would be highly advantageous. An equivalent combination of relevant education and applicable job experience may be considered. An additional degree in basic sciences is a plus (MSc, PhD).
- Knowledge, experience, and skills typically developed by a strong track record of accomplishment in the field of translational research
- Strategic thinking skills with the ability to formulate, develop and execute clinical strategies.
- Experience in the design and conduct of Phase I studies.
- In-depth knowledge of Clinical Pharmacology-related submissions (IND, NDA/MAA/NDS)
- Strong analytical and problem-solving skills.
- Ability to contribute to the development and interpretation of human pharmacodynamic and PK/PD modeling.
- Excellent scientific written, interpersonal communication and networking skills with the ability to build cross functional bridges
- Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.
- Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization.
- The ability to work with attention to detail in a time sensitive environment
- Self-motivation and ability to work with limited supervision
- Strong familiarity with good clinical practices and International Conference on Harmonization Guidelines
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 functional area and related organizational objectives. Erroneous decisions will have a serious impact on the overall success of functional area and may impact the long term success of the company.
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. 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