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Patients Come First!

Clinical Trial Manager (Temporary) - Clinical - Bridgewater, NJ

Position Overview

The Manager, Clinical Trials will work closely with the Director, Clinical Operations and Osmotica Clinical Development team on the design, execution and oversight of clinical trials (all clinical phases) related to pharmaceutical product development and registration.  The position is responsible for the overall operational planning and activities for the implementation and conduct of studies (clinical trials, IIT studies, compassionate use and registries) including data management activities, ensuring that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements and within established timelines and budgets.  The position is involved in the scientific conduct of the study and acts as the leader of operational disciplines to guarantee release of high quality data in close collaboration with other department representatives (e.g., Regulatory Affairs, Project Management) and external vendors (CRO, Data Management, Biostatistics, Medical Writing, etc.).

Duties and Responsibilities

  • Contribute to the development and review of clinical study protocol synopsis, protocol and amendments to ensure operational feasibility.
  • Contribute to development and review of the Case Report Form (CRF) content and testing of the final CRF. 
  • Actively participate in clinical contract research organization (CRO) and vendor identification, selection and oversight.
  • Oversee study start-up activities including feasibility and site selection.
  • Develop study-specific procedures, study plans and documents including Clinical Monitoring Plan, Data Management Plan, Data Validation Plan, Case Report Forms (including testing) and completion guidelines, Data Review & Surveillance Plan and/or other operational and essential documents.
  • Review vendor-developed or co-developed documents (e.g., specifications, scope of work, operational manuals, communication plans, retention and recruitment plans, data transfer plans, etc.) as requested to provide operational input (including on-time and high quality). 
  • Ensure appropriate testing/UAT are performed as required (e.g., eCRF screens, database structure, data loading, etc.).
  • Ensure that clinical and data management standards are followed for the study data management
  • Ensure proper oversight and communicate to teams on monitoring activities, data flow, and data validation and when applicable, coordinate the centralized review of procedures.  Perform patient data validation. 
  • Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) and relevant systems and databases as required.
  • Coordinate and support field-monitoring activities through regular meetings/teleconferences and/or visits to clinical study sites and training of monitoring teams.
  • Prepare and lead data review meeting; organize and contribute to medical review meetings.
  • Collect, synthesize and report study information.  Maintain and provide information for monthly study summary (including enrollment curves and timelines) in a timely manner.
  • Participate in the development/follow-up of the study budget and selection and management of vendors.  Define needs, tasks and responsibilities of external vendors, review contracts, estimate costs of logistical aspects of the study and ensure tracking of payments for operational aspects of the study in collaboration with the Finance department.
  • Develop and oversee Key Risk Indicators and Key Performance Indicators and address and escalate issues and trends, as needed.
  • Assist in preparation and oversight of study audits/inspections both internal and external.  Ensure preparation and proper responses to audit/inspection reports & consolidation of findings and communicate important observations to VP, Clinical Development. 
  • Perform periodic Trial Master File quality review.
  • Contribute to development and review of department processes and procedures.
  • Accountable for operational oversight of the clinical program conducted within Clinical Development and  coordinate with CRO personnel working on the designated program to ensure operational consistency, identify possible synergies, and ensure that the team works closely together to meet the program goals on time and with high quality. 
  • Serve as the primary contact for escalation of program issues/information within Clinical Development and ensure that the VP, Clinical Development and Project Team is being provided with regular reporting on the program progress.  Provide input to help ensure alignment according to risk adjustment and study milestones.
  • The CTM will work with external vendors in the planning and execution of Investigator Meetings both domestic and international.
  • Travel is required up to 20%, both domestic and international.

Experience and Qualifications

  • 7+ years of professional experience within the pharmaceutical industry or clinical-related discipline including at least 5 years clinical research experience.
  • BS/BA degree or equivalent (background in life sciences preferred)
  • Extensive working knowledge of international regulations, guidelines and good practices pertaining to clinical trials.
  • Strong leadership, project management and planning skills.
  • Proven ability to demonstrate strong decision-making and problem-solving skills.
  • Excellent verbal and written communication skills including ability to clearly articulate information and interact effectively with cross-functional team members.
  • Ability to prioritize and work within established timelines in a fast-paced environment.
  • Ability to understand and convey scientific information to audiences of different backgrounds.
  • Ability to work both independently as well as in a team environment.
  • Proficient in Microsoft Office.
  • Strong analytical abilities and attention to detail.
  • Strong organizational and time management skills.
  • Flexibility to manage shifting demands and changing priorities, proactively looking for ways to contribute.
  • Ability to anticipate and timely escalate issues and to define appropriate action plans.
  • Experience in managing and leading international meetings (Clinical Trial Team, advisory board meeting, etc.).
  • Ability to work in an international environment with internal and/or external partners (CROs).
  • Knowledge of industry data management standards and practices.
  • Demonstrates critical thinking, sound judgment, and initiative to solve problems.

About Us

Osmotica Pharmaceuticals is a global specialty pharmaceutical company with a proven history of developing commercially successful pharmaceutical products using a proprietary osmotic technology platform.  In February 2016, Osmotica Pharmaceuticals combined with Vertical Pharmaceuticals, LLC and Trigen Laboratories, LLC to create a world-class, fully-integrated specialty pharmaceutical and generics company.

Vertical Pharmaceuticals, LLC was founded in 2003 with a mission to develop, market, and acquire products offering therapeutic benefits for patients and healthcare providers. Vertical Pharmaceuticals supplies branded prescription products, specializing in Neuroscience and Women’s Health with brands such as Lorzone®, Divigel®, and OB Complete®.

Trigen Laboratories, LLC is a generic pharmaceutical company offering unique products across an increasing array of categories. Trigen seeks to bring value-driven generic products to its customers, working vigorously with its partners to identify and develop products which face an assortment of challenges. Additionally, Trigen identifies unique marketing opportunities and is steadfast in its pursuit to deliver products to best serve these markets.

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability or veteran status.

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Brian Markison, Chairman of the Board and Chief Executive Officer

Brian Markison has served as Chairman of the Board and Chief Executive Officer of Osmotica since 2016. Mr. Markison is a healthcare industry veteran, with more than 30 years of operational, marketing, commercial development and sales experience with international pharmaceutical companies. He has served as an advisor to Avista Capital Partners since September 2012. He previously served as the President, Chief Executive Officer and board member of Fougera Pharmaceuticals, Inc., a dermatology-focused specialty pharmaceutical company sold to Sandoz Ltd., the generics division of Novartis AG. Before leading Fougera, Mr. Markison was Chairman and Chief Executive Officer of King Pharmaceuticals, Inc., which he joined as Chief Operating Officer in March 2004. He was promoted to President and Chief Executive Officer later that year and elected Chairman in 2007. Prior to joining King Pharmaceuticals, Inc., Mr. Markison held various senior leadership positions at Bristol-Myers Squibb. He serves as Chairman of the Board of Lantheus Holdings, Inc. and is on the board of directors of Avista Healthcare Public Acquisition Corp., National Spine and Pain Centers, LLC and Braeburn Pharmaceuticals, Inc. He is also a Director of the College of New Jersey.

James Schaub, Executive Vice President and Chief Operating Officer

James Schaub has served as our Executive Vice President and Chief Operating Officer since 2016. Mr. Schaub previously served as Chief Operating Officer of Trigen Laboratories and as Vice President of M&A at Fougera Pharmaceuticals, Inc. He also held several commercial roles of increasing responsibility at King Pharmaceuticals, Inc. Mr. Schaub is a graduate of Middlebury College and holds an M.B.A. from Rutgers Business School.

Andrew Einhorn, Chief Financial Officer

Andrew Einhorn joined as Chief Financial Officer in September 2017. Mr. Einhorn has more than 15 years of experience in the pharmaceutical industry. Mr. Einhorn previously served as the Chief Financial Officer of Edge Therapeutics, Inc., a clinical-stage biotechnology company that he joined as Executive Vice President of Corporate Development in 2013. Prior to that, he was a co-founder, Executive Vice President and Chief Financial Officer at Oceana Therapeutics, Inc. Previously, Mr. Einhorn was a co-founder and Chief Financial Officer of both Esprit Pharma, Inc. and ESP Pharma, Inc. Mr. Einhorn is licensed as a Certified Public Accountant in the State of New Jersey and holds a B.S. in Finance and Accounting from American University.

Christopher Klein, J.D., General Counsel and Secretary

Christopher Klein has served as our General Counsel and Secretary since December 2013. Mr. Klein previously served as the General Counsel of Fougera Pharmaceuticals, Inc. and as Deputy General Counsel at King Pharmaceuticals, Inc. Mr. Klein spent six years in senior legal roles with Bristol-Myers Squibb Company. Mr. Klein holds a B.A. in Biology from Adelphi University, an M.A. in Education from Columbia University and a J.D. from Fordham University.

Tina deVries, Ph.D., Executive Vice President, Research and Development

Tina deVries, Ph.D. became our Executive Vice President, Research & Development in May 2016. Dr. deVries most recently served as the Principal of TM deVries Consulting, LLC. She was previously Vice President of Nonclinical and Clinical Pharmacology at Actavis plc following its 2013 acquisition of Warner Chilcott plc where she served as the Vice President of Clinical Pharmacology. Dr. deVries holds a B.S. in Pharmacy and a Ph.D. in Pharmaceutics and Pharmaceutical Chemistry from Ohio State University.

Lynn Franklin Palmer, Senior Vice President, Technical Operations

Lynn Palmer has served as our Senior Vice-President, Technical Operations since June 2017. Prior to that, he served as Vice-President, Manufacturing from February of 2016. Before Osmotica, Mr. Palmer served as Executive-Vice-President, Engineering at King Pharmaceuticals for six years. Previously Mr. Palmer led Engineering at Mallinckrodt Inc. (a division of Tyco Healthcare), and served as Vice-President, Production at Inbrand Corporation. Prior to Inbrand, he served in progressive manufacturing management roles at Kimberly-Clark Corporation from 1982-1996. Mr. Palmer holds a Bachelor of Applied Science in Paper Science and Engineering from Miami University.

Jarret Miller, Executive Vice President, Human Resources

Jarret Miller has served as our Executive Vice President, Human Resources since January 2016. Mr. Miller has more than 20 years of Human Resources experience in various roles of increasing responsibility. He previously served as the Head of Human Resources Operations and Services for the Americas at Teva Pharmaceuticals, Inc. Prior to that, he held the positions of Vice President, Human Resources at ConvaTec, Inc. and Senior Vice President, Human Resources at King Pharmaceuticals, Inc. Mr. Miller holds a B.S. in Statistics and Biometry from Cornell University.

David Burgstahler

David Burgstahler has been a director since 2016. Mr. Burgstahler is the President and Co-Managing Partner of Avista Capital Partners and is the Chief Executive Officer of Avista Healthcare Public Acquisition Corp. Mr. Burgstahler was a founding partner of Avista Capital Partners in 2005 and since 2009, has been President of Avista Capital Partners. Prior to forming Avista Capital Partners, Mr. Burgstahler was a partner of DLJ Merchant Banking Partners. Previously, Mr. Burgstahler worked at Andersen Consulting (now known as Accenture plc) and McDonnell Douglas (now known as The Boeing Company). Mr. Burgstahler currently serves as a director of Avista Healthcare Public Acquisition Corp., Inform Diagnostics, Inc., Kramer Laboratories, Inc., United BioSource Corporation and WideOpenWest, Inc. He is also a Trustee of the Trinity School in New York City. Mr. Burgstahler holds a B.S. in Aerospace Engineering from the University of Kansas and an M.B.A. from Harvard Business School.

Sriram Venkataraman

Sriram Venkataraman has been a director since 2016. He is a Partner of Avista Capital Partners, having joined in 2007. Prior to joining Avista Capital Partners, Mr. Venkataraman was a Vice President in the Healthcare Investment Banking group at Credit Suisse Group AG. Previously, he worked at GE Healthcare (formerly known as GE Medical Systems). He currently serves as a director of OptiNose, Inc., Inform Diagnostics, Inc. and National Spine & Pain Centers Holdings, LLC and previously served as a director of AngioDynamics, Inc., Lantheus Holdings, Inc. and Zest Anchors, Inc. Mr. Venkataraman holds an M.S. in Electrical Engineering from the University of Illinois, Urbana-Champaign and an M.B.A. from The Wharton School at the University of Pennsylvania.

Daniel Sielecki

Daniel Sielecki became a director of Osmotica Holdings Corp Ltd. in 2007 and joined the board of directors in 2016 in connection with the combination of Osmotica Holdings Corp Ltd. and Vertical/Trigen. Mr. Sielecki has worked at Laboratorios Phoenix S.A since 1975 and currently serves as a director of Simali S.A., Petroquımica Cuyo S.A and PEPCA S.A. He previously served as a director of Disprofarma S.A.

Carlos Sielecki

Carlos Sielecki became a director of Osmotica Holdings Corp Ltd. in 2007 and joined the board of directors in 2016 in connection with the combination of Osmotica Holdings Corp Ltd. and Vertical/Trigen. Mr. Sielecki currently serves as a director of Simali S.A. and holds a degree in architecture from the University of Buenos Aires.

Juan Vergez

Juan Vergez became a director in 2016. Mr. Vergez served as the President of Osmotica Argentina from November 2010 to May 2016, and as the New Business Director of Osmotica Argentina from May 2016 to December 2017. Mr. Vergez previously served as a director of Nutrifoods, S.A. and has more than 40 years of experience in the pharmaceutical industry.

Sergio Alegre

Sergio Alegre became our Vice President of Global Compliance in August of 2016. Mr. Alegre previously served as Executive Director of Pacira Pharmaceuticals, Inc., where he implemented and oversaw its Compliance Program from August 2012 to August 2016. In addition, he spent seven years as Vice President of Mergers and Acquisitions for Realogy Corporation, following a time in private practice at a law firm in New York City. He holds a B.A. in Political Science and History from Rutgers University and a J.D. from Fordham University School of Law.