Head of Clinical Operations (CNS)
Company: Michael Page
Location: Cambridge
Posted on: March 17, 2023
Job Description:
This Executive Director / Head of Clinical Operations will lead
psychiatric programs. Highly visible role expected to interact with
the executive team, design Clinical Studies, and build and manage
CRO relationships.Ideally, candidates are to have 15+ years of
experience managing clinical trials execution in biotech / pharma
and experience in CNS or psychiatric programs is preferred.Client
DetailsThis client is a rapidly growing clinical-stage biotech
based in the Boston area which develops treatments for multiple
deadly diseases. The publicly-traded company is cash rich has a
robust pipeline with 20+ product candidates and several with a
strong outlook for commercialization.Description
- Provide leadership in Clinical Operations across psychiatric
programs.
- Developing, implementing, and/or managing adequate systems and
procedures to ensure efficient day-to-day operations that meet the
business and its affiliates' clinical trial needs.
- Assisting with clinical trial vendor selection and selection of
vendor personnel to meet clinical trial planning, execution and
clinical trial obligations for the company. This may include the
following personnel from vendors: Clinical Project Managers,
Clinical Trial Managers, Clinical Data Managers, Regulatory
Managers, Medical and Safety Managers, Biostatisticians, and
Medical Writers.
- Ensuring compliance with established clinical and regulatory
guidelines, operating systems and procedures in clinical trials and
maintaining Clinical Operations training including reviewing
training of vendor personnel and external contractors.
- Outlining the scope of clinical trial programs with resource
needs, timelines, and cost of services
- Deploying resources, as necessary, for each new project and
ensuring that clinical program and trial objectives have been
properly communicated to key personnel (e.g., Project Managers, and
other functional areas).Profile
- Minimum education: M.S. / B.S. in a scientific or health-care
related discipline.
- Minimum experience: 15 years in leading clinical trials
execution.
- Track record of successfully managing large, global
multi-center clinical studies for a pharmaceutical and/or
biotechnology company.
- Experience in IND and CTA submissions.
- Experience with psychiatry or CNS preferred.
- Strong operational project management experience including
excellent planning, prioritization, problem solving and
organizational skills. Used to managing multiple priorities.
- Clear written and verbal expression of ideas, an
active/proactive communicator.
- Proven ability to interact, train, and build strong
relationships with CROs, vendors and clinical monitors.If
interested, apply for immediate consideration.Resumes and
availability may be sent to abbymcgrath (at) michaelpage.us.comJob
Offer
- Competitive base salary for biotechnology industry
- Strong financial health ($400m+ across portfolio)
- Annual bonus
- Excellent benefits package
- Equity
- Top level strategic Head position
- Member of executive leadership team
- Ability to hire and grow team in the future
- Novel drug portfolio with strong pipelineMPI does not
discriminate on the basis of race, color, religion, sex, sexual
orientation, gender identity or expression, national origin, age,
disability, veteran status, marital status, or based on an
individual's status in any group or class protected by applicable
federal, state or local law. MPI encourages applications from
minorities, women, the disabled, protected veterans and all other
qualified applicants.
Keywords: Michael Page, Cambridge , Head of Clinical Operations (CNS), Other , Cambridge, Massachusetts
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