Head, Analytical Development Synthetic Molecules – Late Stage (Sr. Director)

Initial Therapeutics, Inc.; Boston (MA); Remote; USD 108,000 - 171,000; Full time

Job summary

Join a patient-focused company dedicated to transforming the pharmaceutical industry. As a Manager of Feasibility, you will play a crucial role in conducting data-driven assessments for clinical studies, optimizing protocols, and developing robust enrollment strategies. This innovative firm values collaboration and empowers its employees to achieve their potential through meaningful work. With a commitment to excellence and a diverse workplace, you will be part of a team that strives to deliver better health and a brighter future for people around the world. If you are passionate about making a difference in clinical research, this opportunity is for you.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Tuition Reimbursement

Paid Volunteer Time Off

Sick Leave

Paid Vacation

Qualifications

• 4+ years in Clinical Operations and Data Analytics within a pharmaceutical setting.
• Proficiency in leading strategic feasibility assessments for clinical studies.

Responsibilities

• Conduct feasibility assessments for clinical studies and develop enrollment strategies.
• Analyze internal and external data to inform protocol development and operational plans.

Skills

Data Analytics

Clinical Operations

Feasibility Assessment

Analytical Competencies

Root Cause Analysis

Education

BS degree in Life Science

International equivalent

Tools

Software Models

Database Structures

Feasibility Tools

Job description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Are you looking for a patient-focused company to inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager, Feasibility based remotely, reporting to the Director, Feasibility and Enrollment Forecasting.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers and work towards excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

GOALS:

• Conduct data-driven feasibility assessments for Phase I – IV clinical studies, including protocol design optimization, country/site feasibility and selection, enrollment strategy and modeling, with limited supervision.
• Utilize internal and external competitive intelligence data to develop data-driven study start-up forecasts, benchmarking assumptions, robust and accurate enrollment plans.
• Participate in efforts to implement innovative processes, methodologies, data and technologies that will ensure ongoing delivery of Feasibility and Enrollment Forecasting Services.
• Participate in global initiatives representing CSS&E and GDO in support of Takeda R&D objectives.

ACCOUNTABILITIES:

• Accountable, in collaboration with Director, Feasibility and/or Sr. Manager, Feasibility for the development of the feasibility analyses to maximize efficiency, effectiveness, and acceleration in Takeda’s operational execution of its clinical research studies.
• Ensures consistent standards are applied to the feasibility process across project portfolios and directs continuous improvement activities while developing and implementing TA-aligned strategies / approaches.
• Collects and analyzes internal and external data (e.g. local treatment standard of care, available treatment options approved/reimbursed, local incidence/prevalence of disease, access to targeted patient population, drug landscape, historical/current clinical trial landscape) to influence and inform protocol development, operational plans, and define an optimal geographic country footprint and proposed sites for participation in a clinical study.
• Leverage leading industry tools and data sources to provide data on startup timelines, past recruitment rates and performance (data quality, start-up cycle time, query rate, protocol deviations, inspection results) to assist project teams with study initiation timeline forecasting.
• In partnership with internal stakeholders- synthesize, interpret and integrate data and information to provide clear feasibility recommendations to strengthen data-driven decision making, analyze trends, identify root causes, and provide actionable recommendations across study teams and programs to accelerate study execution.
• Monitor actual patient enrollment performance of assigned studies. In collaboration with the Director, Feasibility and the Takeda study team and CRO, responsible for re-forecasting patient enrollment models to adjust for new influence factors (e.g. change in drug landscape, protocol amendment, increased screen failure rate).
• Define risk/ mitigation planning.
• Works with Feasibility colleagues and study team members to build and expand therapeutic area/indication knowledge.
• Exhibit the ability to perform root cause analysis and determine mitigation steps to removing critical path roadblocks related to study execution and patient enrollment.
• Ability to provide data-driven recommendations to assist with decision making at a study level.
• Develop strong analytical competencies including the use of clinical data sets to facilitate trial planning, forecasting, and modeling.
• Act as a role model for Takeda’s values.

EDUCATION & EXPERIENCE:

• BS degree or international equivalent required; in a life science preferred,
• 4 or more years in Clinical Operations, Data Analytics, global feasibility, and trial optimization with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor required.
• 2 or more years of direct responsibility in leading strategic feasibility assessments of global clinical research studies at a sponsor or CRO or equivalent data analysis responsibilities in a healthcare or pharmaceutical setting.
• Experience with leading edge trial optimization vendors, tools and methods.
• Proficiency with software models and database structures.
• Expertise in principles driving country/site identification, feasibility and study start-up strategies.
• Direct experience in the pharmaceutical industry or related field required.
• Ability to demonstrate and explain the rationale for country and site recommendations based on a data-driven approach.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Massachusetts - Virtual

U.S. Base Salary Range:

$108,500.00 - $170,500.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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