Associate Director, Medical Affairs - Global Medical Information and Operations

Associate Director, Medical Affairs - Global Medical Information and Operations

Location: Boston, MA

Reporting to: Vice President, Medical Affairs

The Company:

Orchard Therapeutics is a leading global, fully integrated, commercial-stage biotech dedicated to transforming the lives of patients with rare diseases through innovative gene therapies.

Partnering with world-leading research institutions in gene therapy, Orchard's portfolio of autologous ex vivo gene therapy programs has demonstrated sustained clinical benefit in over 150 patients across five disease areas. These programs include Strimvelis®, the first autologous ex vivo gene therapy approved by the EMA in 2016, 3 programs in advanced registrational studies in MLD (metachromatic leukodystrophy), WAS (Wiskott Aldrich syndrome) and ADA-SCID (adenosine deaminase severe combined immunodeficiency), 2 other clinical programs in X-CGD (X-linked chronic granulomatous disease) and beta-thalassemia, as well as an extensive preclinical pipeline

Orchard is a publicly traded company (NASDAQ: ORTX) with offices in the UK and the US, including London, San Francisco and Boston.

Job summary

The Associate Director, Medical Affairs - Global Medical Information and Operations reports to the Vice President of Global Medical Affairs. This role will be located in Boston, MA (US). This is an excellent opportunity for an experienced Medical Information professional to oversee both Medical Information as well as operational excellence initiatives within the entire Global Medical Affairs organization. This role offers an unparalleled opportunity for exposure to multiple drug launches in multiple countries in the rare disease space. As the operational lead in the medical affairs team, this role will have a real and timely impact on the execution of Medical Affairs initiatives supporting products with the potential to transform patients' lives.

Key Elements and Responsibilities

Under the management of the Vice President, Global Medical Affairs, the successful candidate will:

• Oversee implementation of the Global Medical Information function:
  • Management of process for inquiry intake, response development, and maintenance of response database
  • Oversight of third party vendors supporting Medical Information activities including call center activities, Medical Information database development/management, and quality assurance
  • Development of standard response database and custom responses with the support of Medical Communications personnel
• Oversee development and implementation of process for evaluating requests for Compassionate Use of pipeline products
• Participate in the review of company communication materials on the Medical/Legal/Regulatory (MLR) Review committee
• Scientific meetings: coordinate Orchard Medical Affairs presence and activities, develop and staff Medical Information booth, and provide other Medical Affairs coverage as needed
• Manage develop and annual updates of all department policies and SOPs, and ensure company training on relevant documents
• Establish and implement process for the review of grant requests for continuing medical education (CME), investigator-initiated studies (IIS) and other requests for funding from Medical Affairs
• Oversee execution of department contracts, purchase orders, and other agreements in collaboration with Finance, Legal, and other colleagues in Medical Affairs
• Provide guidance and oversight of additional operational activities in the department as needed
• Estimated travel 10-20%

Requirements

• 4+ years experience in Medical Information including experience in Medical Information Operations
• Direct experience with additional operational activities as outlined in the job description is highly preferred

Skills & Abilities

• Ability to understand and interpret clinical data and the scientific literature
• Strong skills in project management and operational excellence, including ability to map out key tasks and deliverables for a project and execute the project in line with schedule and budget
• Understanding of general compliance principles of the pharmaceutical industry, in particular the post-marketing environment
• Able to work independently and/or lead cross-functional teams in the execution of operational deliverables
• Strong vendor management skills
• Proactive, solution-oriented approach - able to identify operational needs and partner with colleagues to implement practical solutions
• Ability to work across cross functional teams
• Ability to work with teams and coordinate information from different groups, institutions, and functions within the company from different countries across the world
• Capable of handling complex data set and be able to combine recommendations, propose solutions and implement the decisions

Education

• Advanced clinical or scientific degree preferred (PharmD, PhD, RPh, MSN, MD or equivalents).

Orchard Therapeutics is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.

Benefits

The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plans. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k). Orchard Therapeutics is an equal opportunity employer.

Notice to All Applicants: Orchard Therapeutics participates in E-Verify

For further information on this role do not hesitate to email [email protected]

RECRUITERS

All employment offers and CV's are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.