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

Associate Director, Medical Affairs

As the Associate Director, UCAN Medical Affairs, you will play a pivotal leaders...

Location

United States , Deerfield

Salary:

184000.00 - 253000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Advanced healthcare degree with 10+ years of clinical experience
Background in ICU, Med-Surg, or Clinical Informatics strongly preferred
Prior Medical Affairs experience highly desirable
Proven experience within the healthcare or life sciences industry
Strong leadership, interpersonal, analytical, and problem-solving skills
Clinical trial experience with a solid understanding of Good Clinical Practice (GCP)
Working knowledge of biostatistics and clinical trial design
Strong digital fluency, including advanced PowerPoint capabilities
Expertise in literature review, synthesis, and scientific analysis
Confidence and effectiveness in public speaking and scientific presentations

Job Responsibility

Provide regional Medical Affairs leadership for new product development, ensuring scientific rigor and clinical relevance
Identify evidence-generation gaps and drive regional evidence strategies in collaboration with Global Business Unit (GBU) Medical Affairs teams
Develop and execute scientific communication and non-promotional education (NPE) plans aligned with product and portfolio strategy
Design, lead, and support advisory boards, clinical investigator meetings, roundtables, and scientific forums
Partner with cross-functional stakeholders to shape long-term Medical Affairs strategies, including comprehensive thought leader engagement plans
Represent Medical Affairs at regional, national, and international medical congresses, providing scientific support and translating emerging data into actionable insights
Monitor and communicate scientific trends, opportunities, and risks that may impact the business
Maintain strong alignment with Global Medical Affairs, ensuring collaboration across data generation, clinical trials, publications, advisory boards, CMEs, and literature strategy
Oversee Grants and Sponsorships, ensuring compliance, accurate documentation, and timely execution
Ensure strict adherence to all internal, legal, regulatory, and compliance standards

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

Associate Director, Medical Affairs

As the Associate Director, UCAN Medical Affairs, you will play a pivotal leaders...

Location

United States , Deerfield

Salary:

184000.00 - 253000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Advanced healthcare degree with 10+ years of clinical experience
Background in ICU, Med-Surg, or Clinical Informatics strongly preferred
Prior Medical Affairs experience highly desirable
Proven experience within the healthcare or life sciences industry
Strong leadership, interpersonal, analytical, and problem-solving skills
Clinical trial experience with a solid understanding of Good Clinical Practice (GCP)
Working knowledge of biostatistics and clinical trial design
Strong digital fluency, including advanced PowerPoint capabilities
Expertise in literature review, synthesis, and scientific analysis
Confidence and effectiveness in public speaking and scientific presentations

Job Responsibility

Provide regional Medical Affairs leadership for new product development, ensuring scientific rigor and clinical relevance
Identify evidence-generation gaps and drive regional evidence strategies in collaboration with Global Business Unit (GBU) Medical Affairs teams
Develop and execute scientific communication and non-promotional education (NPE) plans aligned with product and portfolio strategy
Design, lead, and support advisory boards, clinical investigator meetings, roundtables, and scientific forums
Partner with cross-functional stakeholders to shape long-term Medical Affairs strategies, including comprehensive thought leader engagement plans
Represent Medical Affairs at regional, national, and international medical congresses, providing scientific support and translating emerging data into actionable insights
Monitor and communicate scientific trends, opportunities, and risks that may impact the business
Maintain strong alignment with Global Medical Affairs, ensuring collaboration across data generation, clinical trials, publications, advisory boards, CMEs, and literature strategy
Oversee Grants and Sponsorships, ensuring compliance, accurate documentation, and timely execution
Ensure strict adherence to all internal, legal, regulatory, and compliance standards

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime