What are the responsibilities and job description for the Scientific Director, Research position at Initial Therapeutics, Inc.?

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Job Description

About the role :

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Scientific Director, Research, in our Cambridge, Massachusetts office.

The Bioanalytical and Biomarker Science and Technologies (BST) department at Takeda is seeking a strong scientific and strategic leader to join the group as the BST Single Point of Contact (SPoC) for the Oncology Therapeutic Area to support clinical development of novel therapeutics across a range of modalities (e.g. small molecules, antibodies, bi-specifics, nucleic acids, cell therapies, and more).
This is a strategic role that reports to the Head of BST and serves as a single point of contact to the Oncology Precision and Translational Medicine (PTM), Quantitative Clinical Pharmacology (QCP), Drug Discovery Unit (DDU), Therapeutic Area Unit (TAU), and other applicable cross-functional partners.
The candidate will work closely with the PTM, QCP, TAU and DDU leadership to define portfolio needs in terms of bioanalytical and biomarker support, translate the needs into the BST strategy and plans, monitor execution and ensure timely fit-for-purpose assay and data delivery to support portfolio progression.

How you will contribute :

ACCOUNTABILITIES

The BST oncology SPoC will be the face of BST to functions within PTS (e.g., DMPK, DSRE, Imaging, etc.) and external partners ensuring a consistent BST strategy is messaged between BST Leads and stakeholders. Attends applicable meetings for cross-functional alignment.

Responsible for strategy and deliverables in collaboration with BST Leads, Functional Heads and Key Stakeholders (DDU, TAU, PTS, PTM, QCP, etc.) providing guidance to BST Leads on scientific strategy and execution relating to all BST deliverables (study start up, context-of use-based assays and associated regulatory guidance, clinical development plans, study protocols, testing strategies, data review and QC, database locks, clinical study reports, regulatory filings and communications, etc.). They may assist in issue resolution and escalate issues as needed.

Maintains portfolio level book of work, ensuring adequate resourcing and skill alignment, and assist in budget review.

Reviews relevant content in key reports, governance documents that contain BST content, and regulatory documentation and communications (e.g., protocols, CSR, IND, NDA, BLA, PMA, briefing books, investigator brochures, Health Authority filings and queries, etc.). They may assist in the writing of Regulatory Responses to Health Authority Inquiries, Questions, and Requests for Information and escalate to the BST LT (Leadership Team) and / or stakeholders as needed.

Participates in Due Diligence and other alliance opportunities for corresponding TAU / DDU, delegating to SME (Subject Matter Expert) as needed.

Cultivates cross-program efficiencies, learnings, and aligned practices. Influences and inspires team members, and maintains a culture of innovation, scientific rigor, operational excellence, and collaboration.

Success in this role will be evaluated by the ability to build effective partnership with relevant colleagues within PTS, PTM, QCP, DDU, TAU and other collaborators, align and deliver on BST deliverables with a focus on high-quality, fiscally responsible and timely delivery of PK, immunogenicity and biomarker data for clinical trials.

Develops and mentors junior DMPK team members.

DIMENSIONS AND ASPECTS

Leadership

The BST oncology SPoC will serve as a key member of the BST leadership team helping drive strategic and tactical operations and formulating broad, long-ranging goals in support of BST and PTS goals.

Decision-making and Autonomy

Independently manages workload and expectations.

Scientifically independent.

Scientific driver for research strategy that impacts group internally and outside area of function.

Interaction

Initiates and leads cross-departmental interactions and collaborations.

Frequent contact with internal and external personnel at various management levels.

Innovation

Makes strategic recommendations for BST oncology portfolio in alignment with stakeholders.

Minimum Requirements / Qualifications :

PhD degree in a scientific discipline with 10 years' experience, or MS with 14 years' experience, or BS with 16 years’ relevant experience in immunology, oncology and / or immuno-oncology, new modalities, a deep understanding of bioanalytical and biomarker strategies, applicable regulatory guidance, clinical trials, endpoints and deliverables.

10 years in the biotechnology or pharmaceutical industry and should be able to work with the BST leads and SME to identify and resolve issues related to drug development and clinical asset progression and decision making.

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 : Boston, MA

U.S. Base Salary Range :

169,400.00 - 266,200.00

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 : Boston, MA

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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