Senior Department Manager for Pharmaceutical Development Job at Life Science Talent (Hørsholm)

Senior Quality Assurance Manager

The Senior Quality Assurance Manager is responsible for assuring conformity of t...

Location

Belgium , Lessines

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a relevant scientific discipline
advanced degree preferred
Minimum of 10 years of experience within the pharmaceutical industry, with progressively increasing levels of responsibility
Minimum 5 years of experience in people management
Fluency in French and English is a must
Being recognized as Qualified Person, as defined in the Directive 2001/83/EC for Medicinal products and as defined in DIRECTIVE 2001/82/EC for veterinary medicinal products is an added value
Problem-solving and analytical skills
Critical and inquisitive mind
Excellent communication and presentation skills
Resistant to stress & demonstration of flexibility in times of change.

Job Responsibility

Supervising all activities at plant level as related to Operational Quality, Complaints and Release
Assure escalation of any potential FA and gather data to assist FA process
Support product release by ensuring timely review and investigation of deviations related to the manufacturing process
Support NCR and CAPA process: root cause identification and continuous improvement
Ensure timely documentation and closure of NCR, CAPA and complaint records
Ensure timely investigation and response to ICARs
Review and assess process and documentation change requests
Participate in internal and external quality system audits conducted by the corporate or regulatory agency representatives
Collaborate with ICO partners for projects or issue resolution (intracompany)
Support quality systems by driving regulatory compliance and continuous improvement activities in accordance with applicable regulations and business goals and objectives

What we offer

Support for Parents
Continuing Education/Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer.

Fulltime

Project Manager

Join Amaris Consulting as a Project Manager dedicated to End-to-End Value Flow (...

Location

Singapore

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Engineering, Life Sciences, Information Systems, or related disciplines
Proven experience in project management within the pharmaceutical or manufacturing sector
Prior involvement in digital transformation projects is highly valued
Familiarity with project management tools and methodologies (e.g., MS Project, Agile, Scrum)
Strong leadership and organizational skills
Excellent communication and stakeholder management abilities
Analytical mindset with a proactive approach to problem-solving
Ability to work independently and as part of a team in a fast-paced environment
Commitment to quality and continuous improvement

Job Responsibility

Lead and manage end-to-end digital projects for EVF initiatives, ensuring alignment with business objectives and timelines
Collaborate with stakeholders across departments to define project scope, deliverables, and success criteria
Develop and maintain detailed project plans, monitor progress, and proactively address risks and issues
Facilitate effective communication between technical and non-technical teams throughout the project lifecycle
Ensure compliance with pharmaceutical industry standards and best practices in manufacturing environments
Drive continuous improvement and innovation in project delivery and execution
Prepare regular project status reports and present updates to senior management and clients

What we offer

Global Diversity: Be part of an international team of 110+ nationalities
Trust and Growth: 70% of our leaders starting at entry-level
Continuous Learning: Internal Academy and over 250 training modules
Vibrant Culture: Afterworks, networking events
Meaningful Impact: CSR initiatives, including the WeCare Together program

Fulltime

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...

Location

Germany; Switzerland

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or advanced degree in life sciences or related field
Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
Cell therapy experience preferred and/or focus complex therapies
Fluency in English
working proficiency in additional European languages a plus
Experience with early phase, complex trials
Experience managing Contract Research Organizations and other external vendors
Good understanding of European regulatory requirements (EMA, MHRA, etc)
Working knowledge of GCP/ ICH regulatory guidelines
Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management

Job Responsibility

Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
Perform hands-on activities not outsourced to vendors, as needed
Author study documents and plans such as ICF and study specific plans
Provide input and review of site training materials
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Proactively identify risks and lead team members to mitigate risks in a timely fashion
Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
Select and manage vendors
Perform and document study-level Sponsor Oversight of outsourced clinical activities
Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms

What we offer

health and retirement
PTO
stock option plans

Global Communication Manager

We are seeking an experienced Global Communication Manager to lead our communica...

Location

Switzerland , Genève

Salary:

Not provided

Teoxane

Expiration Date

Until further notice

Requirements

Master’s degree in Communications, Public Relations, Marketing, or a related field
+10 years of experience in global communication, medical devices or pharmaceutical sector with a focus on internal and external communications and thought leadership
Demonstrated ability to advise senior leaders on strategic messaging and executive visibility
Excellent writing and verbal communication skills across internal and external channels
Strong expertise in shaping brand reputation and managing stakeholder engagement
Successful track record in leading internal communication programs that drive employee engagement
Experienced in developing and executing crisis communication strategies
Skilled in training and supporting local teams to ensure global consistency
Good proficiency with media monitoring tools (e.g., ARGUS, Brandwatch, Cision) for insights and reporting
Effective collaborator across global, multicultural teams and functions

Job Responsibility

Serve as the trusted communications advisor to the leaders, providing ongoing counsel and support for written and verbal communications
Develop presentation materials and expand the executives’ external presences through thought leadership activities
Collaborate closing with CHRP to keep employees informed and engaged through effective communication channels and strategies
Lead and execute strategic internal communications programs, including quarterly town hall meetings and regular updates
Manage the internal communications calendar and create engaging content for various channels
Manage corporate messaging, brand perception, and stakeholder relations to enhance the company's reputation and visibility
Partner with communication and PR colleagues to support executive visibility & campaigns efforts, including conferences, events, media relations and social platforms
Be the point person for media monitoring, coordinating with agency partners, maintaining media coverage tracker and managing media relations inbox
Develop and oversee the creation of high-quality content for various communication platforms, including newsletters, press releases, social media and the company website
Collaborate with the Social Media & Influence function, ensuring alignment with global communication strategy and consistency across platforms and influencer activations

Associate Director, Contracts

We are seeking an experienced biotech industry contract specialist to provide ge...

Location

United States

Salary:

165000.00 - 185000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree, or an equivalent amount of relevant industry experience in a legal or related field, is required
6+ years of experience in the life sciences industry drafting and negotiating a variety of contracts
Public company experience required
Prior in-house experience as a member of a Legal Department or clinical affairs department in a biotechnology or pharmaceutical company drafting and negotiating clinical trial agreements strongly preferred
Experience with confidentiality agreements, master services agreements, consulting agreements, clinical trial agreements, GCP guidelines and regulatory requirements for global clinical trials
Exceptional contract drafting and negotiation skills
Strong verbal and written communication skills, including proven ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization
Excellent professionalism and interpersonal skills
ability to handle confidential and proprietary information using sound judgement and discretion
Experience with contract management systems and electronic signature systems and high proficiency in Microsoft Office applications required

Job Responsibility

Partner with Legal Department members to assist with the drafting, negotiation and management of a high volume of contracts for clinical, research, quality, manufacturing, commercial and other internal business partners, including clinical trial agreements, master services agreements, consulting agreements, confidentiality agreements, research agreements and other business agreements
Act as a liaison between internal business partners, the Legal Department, external vendors and outside counsel as necessary to facilitate contract implementation, renewals, and terminations
Continue to improve the internal contracting process, including assisting with the administration of our integrated contracts management system, developing internal training materials related to the contracting process and identifying steps to increase efficiency
Help develop and implement new policies, procedures and contract templates and provide related education and training to internal clients
Work closely with members of finance and other departments to help ensure compliance with cross-functional policies and procedures
Develop reports, presentations, spreadsheets, memos and other documents for the Legal Department, internal clients and/or the senior management team
Review clinical study informed consent forms and related documents as needed
Assist with completion, review and validation of needs assessment forms in connection with HCP engagements, including to confirm alignment with fair market value and contractual terms
Identify legal, documentation gaps and contractual risks and escalate matters in accordance with protocols and guidance
Provide practical contracts support to internal clients during contract preparation and negotiation

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Associate Director, Clinical Operations

We are seeking an Associate Director, Clinical Operations who will be accountabl...

Location

United States

Salary:

180000.00 - 195000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

BA/BS in life sciences or equivalent
8+ years of clinical research experience, including at least 3 years leading global projects from inception to completion
2+ years’ experience in Biotech industry strongly preferred
Significant knowledge of pharmaceutical industry, drug development and regulatory processes
Experience developing all Clinical trial plans, including site management, risk assessment and mitigation strategies, recruitment and retention plans, trial budgets and program-level budgets
Leader with growth mindset, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety
Strong communication skills with ability to present to a variety of stakeholders and tailor message accordingly
Strong project management skills with ability to collaborate effectively cross-functionally and hold team and CRO members accountable to tight timelines and budgets
High sense of urgency and ability to proactively identify critical path items and develop contingency plans to mitigate risk to budget, quality, and/or timelines
Work comfortably in a fast-paced, dynamic work environment and embrace change

Job Responsibility

Accountable for overall management of multiple clinical trials
Serves as the central point of contact and contributes expertise for clinical trial execution on assigned protocols
Works cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to Clinical Management. Ensures accurate tracking and reporting (dashboard) of study metrics and progress of study through completion
Leads the Clinical Study Team (CST) and may participate in other cross functional program team meetings
Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
Responsible for preparing and/or presenting to executive management as delegated
Develops, reviews and/or consults on clinical trial documents, such as study specific plans, informed consent, clinical protocols, Investigator Brochure, CSRs, yearly updates to the regulatory authorities and status updates
May be responsible for participating and presenting at Investigator Meetings, SIVs and other program meetings
Responsible for study level clinical operations budget forecasting, accrual management and quarterly review ensuring tight control between study forecasts and actuals
In conjunction with key stakeholders, oversee and manage the execution and filing of site clinical trial agreements, review of fair market value, CRO and vendor contracts, NDAs, etc

What we offer

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Senior Manager, Clinical Supplies Management

An experienced clinical supply professional responsible for planning, coordinati...

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

B.A./B.S., M.S., or Ph.D. in a technical concentration or other life sciences
A minimum of 8 years relevant experience
Expert in clinical supply planning/operations and vendor management
Excellent communication, collaboration, problem solving, and strategic thinking skills
Experienced in working within databases, systems, spreadsheets, and using presentation tools
Professional presence and keen insight regarding pharmaceutical development activities and inter-relationships between activities and systems
Process orientation
Resourceful and operationally oriented with ability to lead staff
Ability to develop and critically analyze technical documentation
Experience in the application and interpretation of cGMP, GCP requirements to pharmaceutical development processes and issues that arise

Job Responsibility

Provides clinical supply and product expertise to project teams and develops compound/drug related planning documentation and R&D protocol reviews
Proactively initiates discussion of plans with clinical and technical teams
Independently develops packaging and labeling documentation and Astellas system documentation with first-pass approval quality
Monitors international inventory and shipping trends for efficiency
Monitors packaging activities and department processes and outlines and proposes innovations for continual improvement
Supports staff development through demonstration and training
Serves as a consultative resource in the review of staff documentation and provides guidance
Establishes and monitors project budgetary spend
Remains current with industry practice, new processes, global Astellas business practice, and emerging Regulatory requirements and is responsible for raising awareness and educating the group on an ongoing basis

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Manager, Contract Development

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States

Salary:

122348.00 - 156426.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
OR Master’s degree and 2 years of contract development or contract writing experience
OR Bachelor’s degree and 4 years of contract development or contract writing experience
OR Associate’s degree and 8 years of contract development or contract writing experience
OR High school diploma / GED and 10 years of contract development or contract writing experience

Job Responsibility

Work with internal business partners to manage formulary validation efforts to ensure discounts are appropriately earned by customers
Maintain a comprehensive understanding of the payer and provider landscape with respect to Amgen’s current and future products
Support post-deal contract operations team including contracting interpretation for payment processing, formulary validation, dispute resolution and other activities as needed
Responsible for driving decision-making around rebate eligibility and dispute resolution
Provide project management and subject matter expertise for formulary validation across multiple payers – facilitate multiple account formulary validation teams that include Payer Contracting, Market Access, Legal, and Contract Pricing Execution
Support ad-hoc requests by senior leadership for product and/or customer related business analytics and strategy
Identify, lead and project manage process improvements with the Formulary Validation team and its internal business partners
Provide data analysis and dashboards as needed for Formulary Validation
May assist with department face to face meetings, staff training, etc.
May assist with training programs for Formulary Validation team

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Senior Department Manager for Pharmaceutical Development

Life Science Talent

Location:
Denmark , Hørsholm

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 11, 2026

Expiration:
February 15, 2026

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Job Posted:
February 11, 2026

Expiration:
February 15, 2026