Associate Director, Medical Affairs Job at Baxter (Deerfield)

Associate Medical Director

Associate Medical Director, Oncology. ICON plc is a world-leading healthcare int...

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Medical degree (MD) required
Board certification preferred in oncology/haematology
Minimum of 3 years of experience in clinical research or medical affairs within the pharmaceutical or biotechnology industry
Strong understanding of clinical trial design, execution, and regulatory requirements
Experience in immune oncology
Excellent communication and relational skills
Demonstrated leadership and problem-solving abilities

Job Responsibility

Collaborating with cross-functional teams to design clinical development plans and study protocols
Providing medical oversight and guidance throughout the lifecycle of clinical trials
Ongoing medical review of data, supporting Safety Review Committees
Interpreting complex medical and clinical trial data to support decision-making and regulatory submissions
Contributing to the development of scientific publications, presentations, and regulatory documents
Building and maintaining relationships with investigators, key opinion leaders and regulatory authorities

What we offer

Various annual leave entitlements
A range of health insurance offerings
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks
Life assurance
Flexible country-specific optional benefits

Associate Director Regulatory Affairs

The Associate Director is a senior people leader responsible for the operational...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree, 12 years of experience in CMC and/or Device regulatory, and 5 years of leadership experience
Master’s degree and 14 years of experience in CMC and/or Device regulatory, and 6 years of leadership experience
Bachelor’s degree, 15 years of experience in CMC and/or Device regulatory, and 7 years of leadership experience

Job Responsibility

Provide inclusive, inspiring leadership for staff within the CMC & Device Regulatory team in AIN
Attract, hire, develop, and retain top regulatory talent
foster a culture of learning, engagement, inclusion, and high performance
Ensure staff receive appropriate onboarding, development, and ongoing support
Promote behaviors and ways of working consistent with Amgen’s values and leadership attributes
Oversee and be accountable for regulatory work performed by AIN staff, including global change assessments, state and federal licensure, submission execution, periodic reporting and process enhancements
Partner closely with functional and regulatory leadership to drive strategic alignment across Amgen’s products
Ensure high-quality, timely, and compliant regulatory deliverables
Build and maintain strong partnerships with global functional leaders and internal stakeholders
Serve as a trusted and proactive cross-functional partner

What we offer

Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment

Associate Director, Regulatory

This role will serve as the Regulatory Lead for our pivotal program leading to B...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or related field required (advanced degree preferred)
Minimum of 5 years of experience in regulatory affairs for biopharmaceuticals or cell therapy (preferred)
Strong understanding of the drug development process from pre-clinical to commercialization, (prior BLA experience required)
Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IND, CTAs, and BLAs/MAAs and related health authority interactions
Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions
Excellent communication, negotiation, and leadership skills
Strong team orientation and passion for continuous self-development

Job Responsibility

Regulatory Strategy Development: Manage all regulatory aspects of Cabaletta’s lead program through pivotal clinical studies and BLA/MAA approval, including the preparation of clinical trial applications, amendments, correspondence, applications for expedited programs, health authority meetings, marketing applications, and labeling and promotional reviews for regulatory agencies, including FDA, Health Canada, EMA, MHRA and other countries, as applicable
Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development
Stay informed about evolving regulations and guidelines related to cell therapy and adapt strategies accordingly
Assess and communicate potential regulatory risks and propose mitigation plans
Regulatory Submissions and Compliance: Prepare and oversee the submission of regulatory documents, including INDs, CTAs, BLAs/MAAs, and other relevant submissions to regulatory agencies (e.g., FDA, EMA)
Ensure the quality and accuracy of regulatory submissions, adhering to timelines and requirements
Ensure compliance of programs and submission documentation with current regulations and guidelines governing cell therapy products
Regulatory Interactions: Represent the company during interactions with regulatory agencies, including meetings, teleconferences, and written communication
Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities
Coordinate and prepare responses to requests for information from regulatory agencies

What we offer

health and retirement, PTO, and stock option plans

Associate Director Biostatistics

Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN)...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate in Statistics/Biostatistics (or related subject with high statistical content) with at least 12+ years of post-graduate statistical experience in the pharmaceutical industry or medical research
Master’s degree in Statistics/Biostatistics (or related subject with high statistical content) with at least 16+ years of post-graduate statistical experience in the pharmaceutical industry or medical research

Job Responsibility

Provide sound statistical guidance to clinical development, reimbursement, and medical affairs
Oversee statistical contributions to protocols, randomization specifications, statistical analysis plans (SAPs), clinical study reports (CSRs), and key trial documents
Ensure alignment of study design and analysis with scientific rigor, regulatory requirements, and Amgen policies
Collaborate cross-functionally with global teams to deliver high-quality analyses, publications, and regulatory filings
Contribute to innovative trial designs, advanced methodologies, and process improvement initiatives
Execute biostatistical strategies across the product lifecycle, from early development through post-marketing
Provide consultancy and training to colleagues across R&D
Support governance of outsourced statistical activities, ensuring adherence to Amgen standards and regulatory compliance
Represent Biostatistics in cross-functional and external interactions (e.g., with regulatory agencies, investigators, or data monitoring committees)
Drive technology adoption leveraging AI capabilities to streamline statistician’s work

What we offer

Vast opportunities to learn and develop within our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Associate Director, Commercial Learning & Capability Delivery – Enzymes Therapies

As Associate Director, Commercial Capability & Learning Delivery – Enzyme Therap...

Location

United Kingdom , London

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Science required, advanced degree preferred
Minimum of 7 years of demonstrated success in sales training and/or sales experience within biotech or specialty pharmaceutical areas (e.g., oncology, cardiovascular)
Extensive experience in designing and delivering Therapy Area and Product Training programs is required
Experience with product launches, specialty pharmaceutical environment/rare disease is strongly preferred
Proficient in leveraging Learning Management Systems to optimize training delivery and learner engagement
Capability Architect, not just a Trainer – Bring strong business acumen and systems thinking
Facilitation Excellence – An engaging presenter and coach
Instructional Design & Delivery Mastery – Deep expertise in adult learning principles
Scientifically Grounded: Demonstrates fluency in clinical data, disease state education, and product mechanisms of action
Business Impact Owner – Demonstrated expertise in defining and tracking KPIs

Job Responsibility

Spearhead the design and delivery of transformative capability programs for Enzyme Therapies across EMEA and APAC
Partner with global colleagues to co-develop the Global Learning Plan and translate it into a regional roadmap
Serve as a global-to-local connector, ensuring programs resonate regionally while scaling globally
Leverage AI-enabled tools and digital platforms to design and personalize curricula across modalities
Act as a competitive readiness shaper, co-developing regional contributions to the global playbook
Reinvent how virtual learning is delivered in the region
Cultivate strong partnerships with field, marketing, medical affairs, and market access leaders
Manage regional vendors, budgets, and contracts
Ensure all learning programs are designed, delivered, and validated in strict alignment with pharma compliance, regulation, and validation standards
Use learner feedback, business outcomes, and analytics to continuously improve program design and demonstrate measurable impact

Fulltime

Medical Affairs Associate Director, CEEMEA

The role is responsible for defining, shaping, and executing Medical Affairs str...

Location

Poland , Warsaw

Salary:

400000.00 PLN / Year

Baxter

Expiration Date

Until further notice

Requirements

MD required with specialty training in functional area
15+ years total professional experience
Minimum 10 years clinical, regulatory, or scientific experience
8+ years Medical Affairs experience in pharma/biotech/medical devices
Demonstrated regional or global leadership experience strongly preferred
Proven experience in strategic Medical Affairs leadership across multiple markets
Fluent English is mandatory
Leadership & Collaboration: Proven people management, strategic operational oversight, and a strong team-player mindset
Communication & Strategy Delivery: Clear, concise written and verbal communication
ability to define and deliver service strategies

Job Responsibility

Defining, shaping, and executing Medical Affairs strategy across the assigned cluster (CEEMEA)
Ensuring optimal clinical value, scientific credibility, and medical governance of Baxter’s current and future portfolio
Driving strategic medical planning, external scientific leadership, cross-functional alignment, and people development
Ensuring full compliance with global and local regulations
Acting as the senior medical authority at regional level, acting as a strategic partner to Commercial, Market Access, Regulatory, PV
Strategic Medical Leadership: Owns and drives the regional Medical Affairs strategy
Provides medical leadership and strategic direction across multiple countries, therapeutic areas, and business units
Acts as the senior medical decision-maker for regional medical initiatives, investments, and prioritization
Portfolio & Evidence Strategy: Leads regional evidence generation strategy
Oversees the scientific positioning of Baxter’s portfolio

What we offer

Competitive salary, annual bonuses, recognition award program
Possibilities for development on a personal and professional level
Package of benefits including Private medical care (Lux Med), Life Insurance, Multisport card
Bax4U - cafeteria/lunch cards (300 PLN)
PPE program with very attractive conditions available for each employee after 3 months
Educational support: fully covered language courses (English or other languages according to business needs), financial certifications (ACCA, CIMA)
Co-financing of holidays and an additional 2 days off from work annually
Day off for birthday!
Employee Stock Purchase Plan
Bax Flex - hybrid model (3 days from the office)

Fulltime

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