Senior Medical Director, Global Medical Safety (Oncology) - Remote US

Initial Therapeutics, Inc.; United States; Remote; USD 257,000 - 405,000; Full time

Job summary

A leading biotechnology company seeks a Senior Global Safety Lead with extensive experience in pharmacovigilance and patient safety for oncology products. The successful candidate will oversee safety strategies, lead cross-functional teams, and ensure comprehensive risk management in a collaborative environment, contributing to the development of cutting-edge therapeutics.

Benefits

Medical, dental, and vision insurance

401(k) plan with company match

Tuition reimbursement program

Paid vacation and sick time

Paid volunteer time off

Qualifications

• Minimum of 8 years experience in Drug Safety/Pharmacovigilance.
• Minimum 3 years of people management experience.
• Proven ability to work in an international environment.

Responsibilities

• Leads GPSE Safety Team and Safety Management Team.
• Manages cross-functional benefit-risk assessments.
• Oversees risk management plans for compounds.

Skills

Leadership

Interpersonal Skills

Team Spirit

Coaching Skills

Education

Medical Degree (M.D. or D.O.)

Board Certification

Job description

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Job Description

OBJECTIVE:

• Serves as a senior-level Global Safety Lead (GSL) and Company-wide patient safety expert for assigned oncology pharmaceutical / biological / drug-device combined products, accountable for the safety strategy and major safety deliverables for each assigned product.
• Depending on resource allocations, may directly manage a group of GSLs and PV Scientists responsible for overseeing the medical safety profile for assigned products.
• Interacts with and influences colleagues from other functions to ensure the successful development, design and implementation of comprehensive safety and benefit-risk assessment strategies for products.
• Oversees signal detection and risk management activities for assigned products and ensures that development plans include comprehensive safety assessment plans.

ACCOUNTABILITIES:

• Leads GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned oncology compounds and products.
• Represents the cross-functional program team as a product safety profile and risk mitigation expert for internal (e.g., Takeda Safety Board) and external (e.g., Independent Data Monitoring Committee) stakeholders.
• Manages cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products.
• Leads the interpretation of safety data from internal and external sources, assessment of ensuing scientific and medical implications, and communication of the impact of same both in terms of “go/no go” decisions or modification of development plan or study design, including potential impact on timeline or product labeling, ensuring the primacy of patient safety.
• Mentors GSLs and PV Scientists with respect to oncology compounds in development and marketed drugs, safety monitoring and risk management assessment and analysis.
• Supports cross-functional team evaluations in preparation for presentations to the Takeda Safety Board and similar forums. The Senior Medical Director will be a key player in the preparation and presentation of materials to the Takeda Safety Board and similar forums.
• Manages the reactive response to emerging safety signals.
• May perform the medical safety evaluation of projects for new business development opportunities (e.g., due diligence evaluations).
• Ensures high quality analyses of safety information, in support of safety update regulatory submissions, investigational and new drug applications and interactions with regulatory authorities worldwide.
• Assists the Global Medical Safety Oncology Therapeutic Area Head in assessing the implications of emerging regulatory intelligence and developing strategies for adapting processes and procedures.
• Oversees risk management plans for compounds in development and marketed drugs.
• Ensures that GSLs are proactively identifying safety concerns and developing contingency strategies that address these challenges.
• Maintains professional knowledge and accreditation by active participation in continuing medical education activities, and fosters a community of continual learning.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Medical Degree (M.D. or D.O.) or internationally recognized equivalent, with direct clinical patient care experience following post-graduate training and appropriate grounding and knowledge of general medicine. Board certification and licensure preferred.
• Minimum of 8 years experience in the pharmaceutical industry within Drug Safety/Pharmacovigilance, with both investigational and marketed products.
• Minimum 3 years people management experience and/or proven leadership experience in managing a global, matrix team.
• Proven ability to work in an international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills.

LICENSES/CERTIFICATIONS:

• M.D. or D.O. (or equivalents).
• Board certification and licensure preferred.

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:

$257,600.00 - $404,800.00

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-termincentives. 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.

LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Job Exempt

YesIt 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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