Program Director Jobs in New Jersey

Job Title: Associate Director/ Director, Psychiatry Company: Forest Laboratories, Inc. Location: Jersey City, NJ Description: II. PRIMARY JOB RESPONSIBILITIES: Responsible for implementing the clinical development and clinical trial process from inception to completion for one or more clinical programs. Includes managing and supervising study teams, and interfacing with other departments and vendors as applicable. 1. Delivers Business Results * Responsible for supervising all aspects of clinical program management and data review, and study and program activities from initiation to final report. * Contribute to design of clinical protocols. Authors and champions the approval of protocols and study reports. * Participate in IND and NDA/sNDA submission activities. * May also participate in development of Clinical Development Plans (CDP). * MDs will be responsible for the medical oversight of the clinical trial or program. MDs may also function as the Study Physician. * Responsible for creating and managing study budgets for clinical programs. * Responsible for presentations at investigator meetings, partner meetings and internal team meetings. * May participate in the preparation, review and approval of product labeling and related promotional materials. * Liaise with partner company, coordinate Advisory Board meetings, and may represent Clinical Development on Project Teams and Medical Marketing meetings. * May provide support and advice to Marketing for product commercialization and lifecycle management. * May participate in review of in-licensing and due diligence activities for candidate compounds. 2. Enhances Organizational Performance * Coordinate with and provides guidance to other line functions to ensure project metrics and deliverables are met. * Contribute to process improvement efforts including task forces and committees. * Promote team cooperation and team morale. * Support efforts with business partners as part of joint project teams to achieve effective alliances. * Promote high performance work environment through awareness of global industry standards. * Maintain awareness of scientific, regulatory, business events and information relevant to therapeutic area responsibilities. 3. Demonstrates Personal Leadership * Serve as next line of management (beyond Sr. CS/Asst. Director) in dealing with and troubleshooting issues involving vendors, CROs and sites. * Lead Clinical Team Meetings, and follows up with line functions as issues arise. * Drive data review process and manage workload junior staff. 4. Develops human capital * May have two (2) or more direct reports. * Provide mentoring, oversight, and career development/guidance to direct reports and other junior staff. III. ADDITIONAL JOB RESPONSIBILITIES: 1. May serve as a therapeutic area consultant to other in-house teams within Forest Research Institute. 2. Participate in the writing and/or presentation of data at professional meetings, and reports for presentation and publication. IV. POSITION QUALIFICATIONS: Education: Advanced degree PharmD, PhD, MD) required in a health-related field. Experience: * Minimum of 2-5 years pharmaceutical,industry experience in drug development and/or commensurate clinical/medical research experience. Therapeutic expertise reuired in psychiatry. * Demonstrated ability to successfully develop, implement and complete multiple clinical trials and/or programs.

Job Title: Associate Director Director, Psychiatry Company: Forest Laboratories Inc. Location: Jersey City, NJ Description: II. PRIMARY JOB RESPONSIBILITIES:Responsible for implementing the clinical development and clinical trial process from inception to completion for one or more clinical programs. Includes managing and supervising study teams, and interfacing with other departments and vendors as applicable.1. Delivers Business Results* Responsible for supervising all aspects of clinical program management and data review, and study and program activities from initiation to final report.* Contribute to design of clinical protocols. Authors and champions the approval of protocols and study reports.* Participate in IND and NDA/sNDA submission activities.* May also participate in development of Clinical Development Plans (CDP).* MDs will be responsible for the medical oversight of the clinical trial or program. MDs may also function as the Study Physician.* Responsible for creating and managing study budgets for clinical programs.* Responsible for presentations at investigator meetings, partner meetings and internal team meetings.* May participate in the preparation, review and approval of product labeling and related promotional materials.* Liaise with partner company, coordinate Advisory Board meetings, and may represent Clinical Development on Project Teams and Medical Marketing meetings.* May provide support and advice to Marketing for product commercialization and lifecycle management.* May participate in review of in-licensing and due diligence activities for candidate compounds.2. Enhances Organizational Performance* Coordinate with and provides guidance to other line functions to ensure project metrics and deliverables are met.* Contribute to process improvement efforts including task forces and committees.* Promote team cooperation and team morale.* Support efforts with business partners as part of joint project teams to achieve effective alliances.* Promote high performance work environment through awareness of global industry standards.* Maintain awareness of scientific, regulatory, business events and information relevant to therapeutic area responsibilities.3. Demonstrates Personal Leadership* Serve as next line of management (beyond Sr. CS/Asst. Director) in dealing with and troubleshooting issues involving vendors, CROs and sites.* Lead Clinical Team Meetings, and follows up with line functions as issues arise.* Drive data review process and manage workload junior staff.4. Develops human capital* May have two (2) or more direct reports.* Provide mentoring, oversight, and career development/guidance to direct reports and other junior staff.III. ADDITIONAL JOB RESPONSIBILITIES:1. May serve as a therapeutic area consultant to other in-house teams within Forest Research Institute.2. Participate in the writing and/or presentation of data at professional meetings, and reports for presentation and publication.

Job Title: Medical Director/Senior Medical Director, Psychiatry, US Medical Company: Novartis Corporation Location: East Hanover, NJ Description: The Medical Director/Senior Medical Director, Psychiatry, US Medical, will be experienced in drug development and medical affairs, and possess extraordinary leadership competencies and the perspective needed to develop and ratify strategy around drugs. This individual will oversee development and life cycle management for Schizophrenia/depression products. S/he will be responsible for the strategy, development, management and implementation for Phase II-IV product support studies for the Psychiatry franchise, including the conduct of global development and local (US) Phase IV studies, both within the approved indication and as pilot studies for new indications, and may also be involved in providing input for global Phase IV trials. The position includes extensive involvement with global development colleagues, marketing and sales, including conduct of investigator training meetings, field force training, sales material development and review, presentations at grand rounds, local advisory boards, speaker training meetings, and meetings with major healthcare providers. Additional representative responsibilities include the following: Serve as a U.S. Medical team leader. Provide strategic oversight and leadership for clinical development (Phase II, IIIb-IV), pre-registration, label extension, pre-market, launch and post launch strategies and life cycle management. Provide mentorship and coaching to product team leaders, as well as attend scientific meetings and foster and develop strong relationships with investigators. Facilitate and merge strong science into commercially viable products utilizing aggressive timelines; integrate scientific rigor, medical need and commercial value into compelling clinical plans culminating in successful registration and marketing. Contribute to the development of new indications for existing products. Develop and implement reliable and high-value publication strategies for new and existing products. Identify and implement high value strategies for product life cycle development and expansion. Team responsibilities include U.S. medical affairs support for in-line and pre-launch products, including strategic and tactical planning and design, implementation and timely completion of Phase II, III and IV studies and addressing post-marketing concerns. Work in, and enable a positive team environment and interact with global clinical, scientific and marketing teams. Prioritize and resource pre-market launches and post-market medical programs. Successfully create a bridge between clinical development teams and provide medical expertise to the commercial product development teams. Significant U.S. and European travel (20-25% annually, up to 40% seasonally).A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field. We're committed to peak performance, improving the quality of life, and embracing and leveraging diverse backgrounds, cultures and talents to achieve competitive advantage. Novartis is an equal opportunity employer M/F/D/V. PRINCIPALS ONLY!Minimum requirementsA MD or DO degree with 3-5 years of pharmaceutical industry experience is required; Board Certification/Eligibility in Psychiatry and clinical/research background in Psychiatry would be a plus. Experience in managing clinical trial conduct for psychiatric disorders is essential. Firm working knowledge of GCP, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies designated for review by regulatory authorities. Medical Affairs and U.S. marketing experience, to include a well documented history in medical development of Psychiatric therapeutics and of bridging proactive relationships among product development, clinical development and marketing teams. A well-established network within the medical research community that will attract high-caliber professionals into the Novartis organization. Proven ability to build productive relationships and teams internally and externally, and the ability to develop high potential subordinates into leadership roles. Reputation as an open, available and transparent communicator. Strong leadership and organizational skills; demonstrated personnel management capabilities. Excellent oral and written communication skills. Experience leading large projects/organizations. Ability to travel (U.S. and European; 20-25% annually.

Job Title: Director, Psychiatry(M.D.) Company: Forest Laboratories, Inc. Location: Jersey City, NJ Description: PRIMARY JOB RESPONSIBILITIES: Responsible for the overall clinical development of one or more compounds to fulfill regulatory and marketing objectives. 1. Responsible for supervising all aspects of clinical program management, data analysis and approving all clinical documents, study and program activities. 2. Design and author clinical protocols. 3. Responsible for leading study team in developing and maintaining timelines for all study related activities including patient recruitment, site contact, ongoing data review, analyses plans, and preparation of study report 4. Responsible for preparation and approval of relevant IND and NDA/sNDA submission activities. 5. Responsible for leading clinical team to implement Clinical Development Plans (CDP) and ensure timely and successful registration and launch of compounds. 6. Responsible for oversight of clinical program budgets. 7. MDs will be responsible for the medical oversight of the clinical trial or program. MDs may also function as the Study Physician. 8. Responsible for presentations at investigator meetings, partner meetings and internal team meetings. 9. May review and approve product labeling and related promotional materials. 10. Liaise with partner company, coordinating Advisory Board meetings, and may represent the TA on Project Teams and Medical Marketing meetings. 11. Provide support and advice to Marketing for product commercialization and lifecycle management. 12. Identify and develops contacts with external consultants and opinion leaders to facilitate timely development and approval of pharmaceutical products and to ensure Forest's strong reputation in the medical community. 13. Participate in review of in-licensing drug candidates. 14. Direct a scientific due diligence in review of in-licensing drug candidates. 15. Lead Clinical Team Meetings. 16. May have two (2) or more direct reports. ADDITIONAL JOB RESPONSIBILITIES: 1. May serve as a therapeutic area consultant to other in-house teams within Forest Laboratories, Inc. 2. Participate in the writing and/or presentation of data at professional meetings, and reports for presentation and publication. Education: M.D. required. Therapeutic expertise preferred in: Schizophrenia, Bipolar Disorder Experience: Minimum of 7 years drug development or equivalent experience with emphasis on Phase II/III programs. Demonstrated ability to successfully develop, implement and complete multiple clinical trials and/or programs. Track Record of Regulatory Interaction and Submission Expertise in Therapeutic Area or broad medical knowledge. Proven leadership abilities and a track record of directing multidisciplinary clinical teams. Established authorship and review of documents for regulatory submission. Knowledge, Skills, and Abilities Ability to lead multidisciplinary teams Ability to identify issues, analyze situations and provide effective solutions. Ability to manage multiple tasks in a timely, budget-conscious manner in a matrix environment. Excellent written and oral communication skills. Proficiency in basic computer skills. Participation in multi-disciplinary teams such as project teams. Involvement in process improvement efforts including task forces and committees. Experience in mentoring and developing junior staff.