Sr Manager, Medical Affairs Operations (Investigator Sponsored Studies)

Location
Cambridge, MA, United States
Posted
Oct 31, 2018
Ref
R-00963
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Sr Manager, Medical Affairs Operations (Investigator Sponsored Studies)

Company:
Ipsen Biopharmaceuticals Inc.

Job Description:

Sr Manager, Medical ISS Operations

Cambridge, MA

Company Profile

Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company, focused on innovation and specialty care. At Ipsen, we've created a workplace that recognizes and promotes an entrepreneurial spirit in our employees, and are building a strong legacy of helping patients with difficult-to-treat diseases across oncology, neurosciences and rare diseases. We know we can only be better and smarter if we work diligently together as ONE Ipsen, across all functions and geographies. We strive to break down silos and empower teams to deliver effective therapeutic solutions through highly differentiated medicines for patients with unmet needs.

We take pride in our culture, which is rooted in collaboration, to deliver results for our core customer - the patient. This level of involvement by cross-functional teams promotes a strong sense of unity, and pulls together all colleagues locally and across our key geographies, which span 115 countries across North America, Europe and Asia. As a growing organization, Ipsen North America is comprised of our Cambridge, MA, Basking Ridge, NJ and Toronto, Canada locations, with employees supporting functions including Commercial Operations, R&D, Business Development and Technical Operations.

Our employees are the driving force behind our mission at Ipsen, and to sustain their passion and focus every day, we offer a wealth of fulfilling challenges and growth opportunities through unique leadership and training programs. At Ipsen, you will work alongside industry leaders and contribute within a fast-moving and truly game-changing global organization, recognized for its talent and patient solutions. At Ipsen, we're making hope a reality for the patients we serve.

Position Summary

The Medical Investigator Sponsored Study (ISS) Operations Manager is responsible for the oversight of US Investigator Sponsored Studies (ISS) conducted for Ipsen Biopharmaceuticals, Inc. in Oncology, Endocrinology, Neuroscience, and Rare Diseases. The ISS Operations Manager is responsible for the daily management of USMA ISS Program ensuring compliance with legal, regulatory, and IPSEN policies & process requirements.

The ISS Operations Manager ensures that ISS are conducted and progress according to contract and budget terms. The individual ensures timely delivery of ISS program metrics to assist in the delivery of USMA objectives.

Essential Functions

Responsibilities

Responsibilities will include, but are not limited to, the following:

• Work with US medical/clinical colleagues in daily management of IIS in oncology/endocrinology, neuroscience, and rare disease

• Be the point person for questions regarding the ISS program; receive and review applications for completeness and suitability; prepare and make available application and support materials to review committee; schedule and lead review meeting; and collaborate with Medical Science Liaisons (MSLs) to communicate with ISS applicants

• Manage the ISS submission portal and maintenance of ISS database

• Coordinate meetings and recording of meeting minutes; Ensure the ISS proposals are reviewed and approved according to IPSEN policy and process.

• Work collaboratively with legal/compliance and study institution contacts for contract and budget request, development, negotiation and execution

• Manage study-supplied drug orders, shipments, and returns

• Establish and maintain a strong partnership with cross-functional partners to manage the US

ISS program

• Oversee ISS budget management and forecasting

• Track progress on clinical study milestones, invoices, payments; collaborate with USMA Disease Leads & MSLs on investigator communications

• Track and report all ISS evidence generated, presentations, and publications

• May be involved in other tasks to support IIS and process optimization activities as needed

• Tracks and reports ISS program metrics

Qualifications

Education
  • Bachelor's degree required, advanced degree preferred
  • Degree in Life Science preferred


Experience
  • A minimum of 2 years' ISS program experience is required; previous experience in Clinical Research or CRO is a plus
  • Knowledge and understanding of GCP/ICH
  • Must be detail oriented, highly organized, and able to work independently
  • Proficient with PowerPoint, Excel, and Microsoft Project is preferred
  • Ability to multi-task in a fast-paced environment is required


Core Competencies (Specific knowledge, skills and abilities that enable an individual to effectively perform the job)
  • Maintain up-to-date knowledge of ICH-GCP and FDA regulations.
  • Proficient in the use of computer software systems (Word, Excel, PowerPoint, Share Point, CTMS, EDC software, etc.)
  • Ability to work independently.
  • Effective leadership skills and decision-making skills.
  • Excellent reporting skills.
  • Ability to work across multiple functions and cultures.
  • Ability to travel domestically and internationally as required.
  • Excellent English communication skills: written and verbal.
  • Strong organizational skills and ability to deal with competing priorities.
  • Strong reasoning and creative solving skills.
  • Good presentation skills.


The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.