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Executive Director Translational Medicine

Company: ACADIA Pharmaceuticals Inc
Location: Princeton
Posted on: April 10, 2021

Job Description:

Executive Director Translational Medicine For the safety of our employees and communities in response to COVID-19, ACADIA has implemented a temporary work from home policy. As a part of this shift, we have migrated all interviews to virtual interviewing via phone and video. Position Summary: 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. Primary Responsibilities:

  • 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 Education/Experience/Skills: 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). Must possess:
      • 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 Scope: 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. Physical Requirements: 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 Are you legally authorized to work in the United States? --*
        -- Will you now or in the future require sponsorship for employment visa status (e.g. H-1B visa status)? --*
        -- I hereby certify that I have not knowingly withheld any information that might adversely affect my chances for employment and that the answers given by me are true and correct to the best of my knowledge. I further certify that I have personally completed this application. I understand that any omission or misstatement of material fact on this application or on any document used to secure employment shall be grounds for rejection of this application or for immediate discharge if I am employed, regardless of the time elapsed before discovery. --*
        -- Have you previously been employed by Acadia Pharmaceuticals? --*
        -- U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at Acadia Pharmaceuticals Inc. are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. Gender Please select Are you Hispanic/Latino? Please select Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Please select Form CC-305 OMB Control Number 1250-0005 Expires 05/31/2023 Voluntary Self-Identification of DisabilityWhy are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition. Disabilities include, but are not limited to:
        • Autism
        • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
        • Blind or low vision
        • Cancer
        • Cardiovascular or heart disease
        • Celiac disease
        • Cerebral palsy
        • Deaf or hard of hearing
        • Depression or anxiety
        • Diabetes
        • Epilepsy
        • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
        • Intellectual disability
        • Missing limbs or partially missing limbs
        • Nervous system condition for example, migraine headaches, Parkinson's disease, or Multiple sclerosis (MS)
        • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression Disability Status Please select 1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Keywords: ACADIA Pharmaceuticals Inc, Trenton , Executive Director Translational Medicine, Healthcare , Princeton, New Jersey

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