ADC Therapeutics

Marketing

• Lead and execute regional marketing plans
• Work with the Agency of Record (AOR) and home office to develop and to execute regional marketing plans including asset deployment, media execution (geo-targeting), and congress planning.
• Identify, monitor, and report key performance metrics for the region
• Align with cross functional matrix team on local account planning (Associate Director, Strategic Accounts, Hematology Therapeutic Specialists)
• Identify local and regional HCPs to participate in key commercial projects including webcasts, videos, promotional materials, and training opportunities
• Identify and develop regional and local thought leaders
• Identifies, develops, and engages with local and regional KOLs across, Hematology/Oncology and especially within the lymphoma expert community in the region.
• Works with Agency of Record and brand team to map regional TL influence and support regional account plan development and execution
• Develop and execute regional advisory boards and third-party program plans
• Identify and develop local and regional HCPs to participate in the ADC Therapeutics Speaker Bureau for ZYNLONTA and disease state programs
• Conference attendance and Executive Engagements
• Attend key regional and national conferences to meet with TLs and other key customers and gather competitive insights
• Work with field leadership to coordinate and align on appropriate company presence onsite
• Arrange meetings with TLs and company leadership
• Work with Digital marketing on geotargeting and advertising opportunities.
• Insight gathering for HQ and field leadership
• Collaborates and communicates with headquarters, the region’s field commercial and medical teams, and Clinical Development to maintain KOL coordination and manage appropriate distinction of roles and boundaries among the expertise areas.
• Monitors Lymphoma Treater landscape to understand community beliefs about ZYNLONTA and relevant external (competitor) events and data
• Coordinate and execute local Patient Advocacy events
• Work with Patient marketing, corporate communications, and sales to effectively support advocacy meetings and events especially where appropriate TL engagement is possible
• Agency Management
• Work with Regional Marketing Lead to manage agency partnerships and ensure appropriate budget allocation
• Other duties, as assigned.

Associate Director, Regional Marketing – West Region

Director

• Lead and develop the MSAT function covering ADC end-to-end manufacturing across clinical and commercial stages.
• Define MSAT strategy for external manufacturing aligned with corporate objectives.
• Develop and mentor a high-performing MSAT team with deep expertise in biologics, highly potent payloads, and aseptic operations.
• Serve as a key member of the Operations Management Team to contribute to long-term supply, risk mitigation, and operational excellence initiatives.
• Ensure MSAT team membership within ADCT’s Production Management Teams to serve as manufacturing process interface with CDMOs for all MSAT related activities.
• Oversee and guide: Process development, scale up, and tech transfer at/to CDMOs, Process characterization and validation (PPQ), Ongoing process monitoring and CPV programs.
• Ensure consistent process understanding and control across global manufacturing partners.
• Drive effective issue resolution for manufacturing deviations, CAPAs, and change requests.
• Support CDMO selection, technical due diligence, and onboarding for new manufacturing partners.
• Provide scientific and technical oversight across the full ADC manufacturing lifecycle.
• Assess and implement post approval changes, comparability strategies, and process optimization initiatives.
• Oversee and endorse process improvements to enhance process robustness, yield, cost, and supply reliability.
• Serve as the senior-level accountable MSAT person for regulatory submissions and inspections, including INDs, BLAs, MAAs, supplements to these filings.
• Author, review, and approve CMC regulatory sections and responses.
• Support health authority inspections and technical audits of CDMOs.
• Partner closely with Quality to ensure compliance with cGMP, ICH, and global regulatory expectations.
• Ensure sound scientific justifications for process control strategies, specifications, and lifecycle changes.
• Collaborate closely with Quality Assurance, Quality Control, Supply Chain and CMC Regulatory.
• Provide MSAT input into development programs, commercial readiness, and long range supply planning.
• Participate in internal governance forums, change control boards, and technical review committees.
• Establish and track critical process parameters (CPPs) and CPV metrics.
• Proactively identify and mitigate technical and operational risks within ADC Therapeutics’ external manufacturing network.
• Drive lessons learned, standardization, and continuous improvement across CDMOs and Production Management Teams.

Senior Director, Manufacturing Sciences – Technologies

• Meet or exceed business objectives within our compliance framework
• Establish partnership with key stakeholders within accounts and serve as the single-point of contact within the account for ADC Therapeutics
• Full people management responsibilities for their team of Hematology Therapeutic Specialists
• Develop an understanding of accounts and perception/sentiment towards ZYNLONTA
• Develop robust account plans for each key account and collaborate across the organization to execute on plans
• Will serve as a player/coach for area business including performance of their own accounts as well as managing the performance of their Hematology Therapeutic Specialists
• Be an expert on the clinical profile of ZYNLONTA and clearly articulate the value proposition to key stakeholders
• Utilize approved materials and resources to drive awareness and advocacy for ZYNLONTA
• Understand mapping of physicians and key stakeholders within each account to best drive advocacy for ZYNLONTA
• Partner with appropriate stakeholders within accounts to ensure a positive experience with ZYNLONTA including office staff, pharmacists, business managers, etc., and triaging requests compliantly
• Participate in account reviews and business reviews with the cross-functional ADC team

Associate Director, Strategic Accounts – New England

Compliance

• Act as the primary regulatory representative on, and provide strategic regulatory guidance to, assigned project teams and sub-teams
• Lead the planning and preparation of global regulatory global submissions (e.g., INDs, BLAs, CTR/CTAs, Orphan Drug Applications, meeting requests, BLA submissions)
• Management of, and collaboration with, CRO partners for regulatory submissions
• Represent Regulatory Affairs with licensing partners
• Establish and manage regulatory timelines
• Serve as the liaison between the company and global health authorities, including FDA, for assigned projects
• Prepare meeting requests and briefing documents; assure team is ready for meetings/teleconferences with regulatory agencies including developing strategies for such meetings
• Prepare regulatory development plans for assigned projects
• Develop and maintain regulatory knowledge of US, EU and ROW regulations
• Coordinate and prepare responses to Regulatory Agency requests for information
• Interface with CMC, nonclinical research and clinical research personnel and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities that may impact the company
• Assist in maintaining active INDs/CTAs/CTRs/BLAs (amendments and annual reports)
• Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents

Senior Director, Regulatory Affairs

• This critical position is responsible for further developing and strategically optimizing global Regulatory submissions leading the preparation and maintenance of INDs, BLAs and clinical trial applications (including CTR)
• Developing systems for submissions through the FDA electronic gateway
• Acting as the regulatory lead on assigned project teams if needed
• Reporting to the Head of Global Regulatory Affairs
• Act as the Regulatory Information Management (RIM) system owner with associated tasks linked to this function for all regulatory submissions (US and ex-US)
• Ultimately be accountable for establishing the RIM system to submit regulatory filings through the FDA ESG gateway
• Acts as the ADCT responsible person for all activities with the RIM vendor (system upgrades, compliance etc)
• Collaborate with the Regulatory Lead to plan and prepare global regulatory submissions from a Regulatory Operations perspective (e.g., INDs, BLAs, CTR/CTAs, Orphan Drug Applications)
• Collaborate with CRO partners for global regulatory submissions
• Establish and manage regulatory timelines
• Prepare meeting requests and briefing documents, coordinate and prepare responses to Regulatory Agency requests for information
• Interface with CMC, nonclinical research and clinical research personnel and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities that may impact the company and electronic submissions
• Maintain active INDs/CTAs/CTRs/BLAs (amendments and annual reports) from an operational perspective
• Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents.

Associate Director, Regional Marketing – West Region

Senior Director, Manufacturing Sciences – Technologies

Associate Director, Strategic Accounts – New England

Senior Director, Regulatory Affairs

Director, Regulatory Affairs Operations