Director, Drug Product Development Job at Apogee Therapeutics

Director, CMC Product Development

Location

Denmark , København

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

PhD, MSc, or equivalent in biochemistry, biotechnology, pharmaceutical sciences, or related field
10+ years of experience in CMC development of biologics, preferably antibodies
Proven track record advancing programs from preclinical into clinical development
Strong expertise in bioprocess development, manufacturing, and analytical characterization
Experience working with CDMOs and global regulatory agencies (FDA, EMA)
Deep understanding of GMP requirements and regulatory expectations
Ability to operate both strategically and hands-on in a fast-paced biotech setting

Job Responsibility

Define and lead the CMC strategy for multiple biologics programs
Oversee process development, scale-up, and manufacturing (drug substance and drug product)
Manage and coordinate CDMOs and external partners
Ensure preparation and delivery of high-quality CMC documentation for regulatory submissions (IND/CTA, IMPD, BLA)
Lead technology transfer and manufacturing readiness for clinical supply
Establish and maintain quality standards
Drive analytical development and comparability strategies
Contribute to regulatory interactions and health authority responses
Build and manage internal CMC capabilities as the company grows

What we offer

Be part of a cutting-edge immunotherapy platform with strong differentiation
Work alongside a highly experienced and scientifically driven team
Influence key development decisions and company strategy
Competitive compensation and equity package
Flexible and international working environment

Fulltime

Senior Director, Product Quality Assurance

The Senior Director, Product Quality Assurance, Cambridge (PQA) will be responsi...

Location

United States , Cambridge

Salary:

260000.00 - 320000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelors or Advanced degree in a scientific discipline
15+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and quality. Must have CT/GT/biologics experience
7+ years of Quality management experience with a successful track record in managing CDMOs as well as internal QA systems in a virtual environment
Experience in auditing/vetting of CDMOs
Understanding of worldwide requirements of cGMP and quality systems for commercial and clinical products
Excellent verbal and written communication skills, detail-oriented personality and ability to work and drive change across functions
Experience interacting with regulatory health authorities at pre- and post-approval inspection
Established expertise and training in GxP systems
Ability to evaluate Quality Systems and drive value added enhancements
Strong team player that has a customer service approach and is solution oriented

Job Responsibility

Creating/monitoring and maintaining phase appropriate levels of compliance in all of our CDMOs/external partners
Overall responsibility to ensure initiatives related to quality and compliance are optimized and executed appropriately in the areas of GMP compliance with Beam’s externally focused manufacturing efforts
Provide top level guidance and support on internal GMP activities in the Cambridge location, and globally from a GMP perspective
Quality oversight for GMP operations, primarily encompassing external GMP operations and QC support in Cambridge
Key relationship manager for CDMOs/external partners from a quality perspective
Works cross-functionally with other members of the greater CMC area and program teams for CDMO selection and vetting
Establishes an overall KPI and metrics program to assist in governing the CDMO relationships
Establishes a routine process for continuous improvement of the CDMO oversight processes
Define clear Quality objectives and ensure progress and cross-functional completion of responsibilities
Create and ensure appropriate quality systems are in place to support product release in a compliant and timely manner

Fulltime

Associate Director, Product Quality Assurance

The Associate Director of Product Quality for Cell and Gene Therapy Programs wil...

Location

United States , Cambridge

Salary:

185000.00 - 225000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelors or Advanced degree in scientific discipline
12+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality with at least 4 years of which should have been in a CMC-focused position in Cell and Gene Therapy Quality role
Detailed knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements
Ability to influence without direct authority
Ability to develop into a primary PQL for Beam programs
Excellent verbal and written communication skills, detail-oriented personality and ability to work and drive change across functions
Experience interacting with regulatory health authorities at pre- and post-approval inspection
Strong team player that has a customer service approach and is solution oriented
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
Excellent listening, communication and interpersonal skills fostering team spirit

Job Responsibility

Provides strategic Quality CMC-focused support based on Program Team timelines, milestones, and regulatory commitments
Drives and takes action on Phase Appropriate Quality strategy for Beam’s products
Performs Quality review/approval of records and documentation related to manufacturing such as process defining documentation
Performs product quality impact assessments for product complaints, manufacturing deviations, OOT/OOS results, MRB, adverse trends, etc
Quality reviewer and approver of select technical documents (e.g. complaints, temperature excursion reports, justification of specification (JoS), specifications, method validations, critical quality attribute (CQA) assessment, comparability, risk assessments, continued process verification (CPV), tech transfer, ad hoc testing / characterization protocols, etc.)
Ad hoc Quality representative on Program Team and CMC Team in support of primary PQL
Ensures alignment with regulatory requirements, industry standards / best practices, and Beam initiatives
Support clinical to commercial analytical control strategy
Strategic and technical support across product lifecycle (manufacturing process and analytical method changes, tech transfer, characterization, comparability, validations, technology improvements, etc.)
Reviews manufacturing process performance, analytical method performance, stability data, etc. for signals / trends / patterns to proactively monitor and if necessary, support mitigations

Fulltime

Clinical Development Director

ViiV Healthcare is a global specialty HIV company, the only one that is 100% foc...

Location

United States; United Kingdom , Durham; London

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

B.S. OR Masters OR Ph.D. OR Pharm.D., with 5 plus years of recent drug development experience in a pharmaceutical industry or CRO environment leading the scientific aspects of clinical program(s) and regulatory submission(s)
Prior drug development experience in HIV / infectious diseases
Experience in working with or writing study protocols, informed consent forms and clinical study reports
Experience with reviewing and interpreting clinical and scientific data
Experience in contributing to end-to-end clinical development strategy, including study design, data interpretation, risk assessment, and milestone planning
Experience translating complex study-level issues into broader program-level recommendations and decisions
5 plus years leading cross-functional teams, including internal and external partners (e.g. 3rd parties, academic partners, and subcontracted organizations)
Experience with managing multiple programs concurrently

Job Responsibility

Helps drive the strategy of ViiV Healthcare early- and/or late-stage development programs
Accountable for the development, finalization, and amendments of study protocols with appropriate internal/external stakeholder input while ensuring protocol fulfills strategic objective of clinical development/ integrated evidence plan
Liaises with Operations, Clinical Pharmacology, Medical, Regulatory and Commercial Leads to ensure study/program evaluates key aspects of the Asset Target Product Profile critical to product differentiation/reimbursement where possible
May co-lead Clinical Matrix Teams with the accountable physician
Provides scientific oversight of clinical studies, including assurance that data collection and study analysis plans are aligned with protocols, thereby allowing for intended scientific interpretation of study data and results
Partners with study team to ensure that all regulatory reporting requirements are met
Collaborates with physicians and other study team members and stakeholders to enable appropriate review of safety data
May assist or take leading role in identification of safety review committee members and preparation of interim safety review charter document
Works closely with study physician(s) to help monitor safety and benefit/risk for studies
Works with the study team to help to create evidence generation and scientific outputs including content of investigator meeting, clinical study report, preparation of study results for scientific meetings, congresses, and external journal publications, preparation regulatory documents, and other relevant study documents

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

Senior Director, Drug Safety Operations

The Senior Director, Drug Safety Operations will be provide leadership and direc...

Location

United States , San Diego

Salary:

280000.00 - 300000.00 USD / Year

Arrowhead Pharmaceuticals, Inc

Expiration Date

Until further notice

Requirements

12+ years of experience in Drug Safety/Pharmacovigilance Operations
Bachelor of Science with an advanced degree in pharmacy, nursing or related healthcare field
Strong working knowledge of case management and processing
Experience in using ARGUS or other safety databases
Experience with MedDRA/WHO for coding AEs, medical history, and concomitant medications
Experience with preparation with aggregate reports, preferably for investigational drugs (i.e., DSURs, IND Annual reports) or post-marketing products (i.e., PSUR/PBRER, PADERs)
Working experience with Safety Databases (Argus, ArisG or other) is required
Knowledge of ICH E2B guidelines in clinical and post-marketing studies
Good leadership and organizational skills with the ability to perform multiple tasks efficiently and effectively

Job Responsibility

Lead Case Processing and support safety medical review, generate appropriate queries to contact drug safety vendors (CROs) to complete and clarify SAE case information as needed and work with CRO to determine when cases are complete and ready to close
Ensure corporate compliance with domestic and international adverse event reporting requirements for all products in worldwide development programs
Ensure consistency in investigator causality assessment of SAE reports and source documentation for completeness, accuracy and legibility
Participate in the standardized set-up of new safety projects, including development of Safety plans and documents, and set-up of safety systems
Prepare, support and track PVAs/SDEAs with partners
Monitor compliance with partner Safety related activities needed as per PVA/SDEA
Create and maintain Safety Management Plans and Reporting documents in collaboration with vendors
Review vendor scope and assist with study level budgets as needed
Oversee submission activities for ICSRs and aggregate reports
Collaborate with vendors for TMF Safety documents filing and review

What we offer

competitive salaries and an excellent benefit package

Fulltime

Senior Director, Clinical Development, Oncology

Moderna is seeking an experienced oncology drug developer lead Clinical Developm...

Location

United States , Cambridge, Massachusetts; Princeton, New Jersey

Salary:

210900.00 - 379200.00 USD / Year

Moderna

Expiration Date

Until further notice

Requirements

Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant hematology and/or oncology in an academic or hospital environment
Experience in oncology drug development demonstrated by at least 3 years in the biopharmaceutical industry
In exceptional cases, at least 5 years of experience as an early-phase clinical trialist in academia would be considered
Medical oncology and/or hematology fellowship training is preferred
Experience in oncology and/or hematology immunotherapeutics is preferred
Experience in conducting translationally rich oncology and/or hematology clinical trials is highly valued
Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences)
Outstanding verbal and written communication skills, in addition to excellent organizational skills
Understanding of the entire drug development process, including clinical and non-clinical study design and execution
Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules

Job Responsibility

Collaborate in the development and execution of the Clinical Development Plan (CDP) for assigned oncology assets
Integrates scientific rationale, regulatory requirements, product development plan and commercial goals to optimize clinical study designs aligned with the Integrated Development Plan (IDP) and CDP
Generates data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe
Establishes expeditious clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDP
Collaborate effectively with program counterparts in Translational Medicine, Pharmacometrics, Research, Biostatistics, Clinical Operations, Regulatory, Commercial, and other functional areas as needed
Contributes to and partners with the development of strategic initiatives, such as organizational initiatives within Clinical Development
Plays an active role in the technical and leadership development of Clinical Scientists
Employs visioning and strategic thinking to provide expert leadership of disease/therapeutic area specific strategy for a drug(s) or program(s)
Leads selected clinical development projects for products/franchise of compounds
Able to lead and influence across a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver integrated clinical development strategy, which align to the business strategy and achieves mutual goals related to patient need

What we offer

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
Eligible for an annual discretionary bonus, other incentive compensation, or equity award

Fulltime

Director, Retail Development

Step into a pivotal role at BBC Studios where your expertise will shape the reta...

Location

United States , New York

Salary:

145000.00 - 150000.00 USD / Year

BBC Studios

Expiration Date

Until further notice

Requirements

Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint), Adobe Illustrator and Photo Shop is a plus
Superior writing and proofing skills, with an eye for design
Excellent verbal and written communication skills
Ability to negotiate favorable retail activations and placement
Strong organizational skills and attention to detail
Ten plus years of experience in Retail Development, Licensing or Category Management
Experience managing broad range of retail channels of distribution
Solid network of retail buyers, management and marketing leads across mid-tier, value, drug, grocery, department and off-price channels
Strong familiarity with licensees across all categories
Thorough understanding of the US and Canadian retail and entertainment landscape

Job Responsibility

Cultivate, nurture and grow relationships with Buyers, DMMs and Marketing Leads across key retailers
Develop and execute brand strategies across BBC Studios’ growing portfolio of brands to increase brand visibility, product placement and sell through
Craft compelling, creative, customized and strategic brand presentations for retailers including: Infographics, sizzles, visual graphics, competitive analysis and recaps
Communicate, educate and motivate retail buyers, management and marketing teams on BBC Studios’ brands, content, marketing initiatives and licensing partners with the goal of gaining support, brand presence and driving revenue growth
Analyze available POS to drive sell through, help identify key learnings and new opportunities across US and Canadian retailers
Execute retail marketing activations including digital and in-store events/promotions/campaigns, costume appearances and bespoke opportunities that drive excitement, social engagement, traffic and sales
Collaborate with internal team, licensing partners and agencies to develop meaningful, turnkey retail programs that achieve positive ROI
Analyze and evaluate retail and consumer trends to identify opportunities for brand/retail placement and retail marketing initiatives

What we offer

100% Employer-Paid Medical and Dental Insurance (PPO plans)
Generous Paid Time Off
Flexible, Hybrid Working Arrangements
Work/life balance
Free Retirement Consulting to All Employees
Pet Insurance
Commuter Benefits
Gym Reimbursement

Fulltime

Senior Director, New Product Planning

Reporting to the Chief Business Officer, the Senior Director, New Product Planni...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in life sciences, business, marketing, or a related field
advanced degree (MBA, PharmD, MS) preferred
10+ years of experience in product strategy, new product planning, marketing, or commercial insight roles within biopharmaceuticals
Demonstrated expertise in market research methodologies, insight generation, and translating findings into product strategy
Strong understanding of the drug development lifecycle and how product decisions influence clinical, regulatory, and commercial outcomes
Excellent communication skills with the ability to synthesize complex information into clear, decision-oriented recommendations
Proven ability to influence cross-functional teams without direct authority
Strong team orientation and passion for continuous self-development
Experience supporting development-stage or pre-launch assets, including early asset strategy and indication expansion, highly preferred
Background in rare disease, autoimmune, cell therapy, or other specialty therapeutic areas, highly preferred

Job Responsibility

Lead product-focused new product planning across early- and late-stage programs, including definition and evolution of Target Product Profiles (TPPs)
Design and oversee qualitative and quantitative market research to inform product design, indication prioritization, and differentiation strategy
Translate customer, payer, and market insights into clear product requirements and strategic recommendations for development teams
Partner closely with Clinical Development, Regulatory, and Medical Affairs to ensure development plans reflect real-world market needs and constraints
Assess competitive landscapes, evolving standards of care, and emerging data to guide product positioning and lifecycle planning
Develop product narratives that articulate clinical value, unmet need, and differentiation for internal decision-making and external stakeholders
Support portfolio prioritization through product-level assessments, scenario analyses, and value framing
Prepare and present product strategy updates to governance forums and senior leadership
Establish best practices, tools, and frameworks for product planning and insight generation across the portfolio

What we offer

health and retirement, PTO, and stock option plans

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Director, Drug Product Development

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

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