Job Description

We are seeking a Manager/Senior Manager, Regulatory CMC to join the new and growing Post-Approval Group within the larger Regulatory Affairs Organization. The primary responsibility of this position is to lead, contribute, and execute on post-approval CMC regulatory activities in support of Deciphera’s globally approved marketing applications inclusive of generating high quality and compliant CMC regulatory submissions (Module 2/Module 3) for marketing applications.

This position will report to the Associate Director, Regulatory CMC and can be performed remotely within the US.

What You’ll Do:

• Collaborate with CMC cross-functional team members to plan, write, and review CMC sections of pertinent global regulatory submissions (e.g., marketing and post-approval applications, annual reports, responses to Health Authorities).
• Provide regulatory guidance to cross-functional team members on required post-approval content of Module 2/Module 3.
• Review documentation in support of CMC and QA activities for small molecule commercial programs.
• Review and assess proposed CMC changes for global regulatory impact and post-approval filing requirements.
• Communicate with regulatory Health Authorities on project related matters as needed.
• Provide insight and guidance on implementation of current global regulations with respect to the preparation and submission of CMC regulatory documentation.

Qualifications

What You’ll Bring:

• B.S. in a scientific discipline required (degree in Chemistry strongly preferred); advanced degree a plus.
• Must have 6+ years pharmaceutical industry experience (small molecule) in CMC Regulatory Affairs. Direct experience with global commercial programs strongly preferred.
• Previous experience in either manufacturing, analytical laboratory, or GMP QA preferred.
• Experience in leading the preparation of high-quality CMC regulatory submissions (Module 2 and Module 3) for global marketing and post-approval applications.
• Strong knowledge in global regulatory (FDA, EMA, ICH) guidelines, knowledge of cGMP.
• Previous experience assessing change controls for global impact and developing regulatory strategies to implement assessed changes globally.
• Previous experience leading/supporting interactions with health authorities a plus.
• Proven ability to manage multiple projects, identify, and resolve regulatory issues.
• Attention to detail and ability to work independently as well as part of a team environment.
• Excellent organizational and communication skills, both written and verbal.
• Strong interpersonal skills and the ability to effectively work cross functionally with others.

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Job Description

We are seeking a Manager/Senior Manager, Regulatory CMC to join the new and growing Post-Approval Group within the larger Regulatory Affairs Organization. The primary responsibility of this position is to lead, contribute, and execute on post-approval CMC regulatory activities in support of Deciphera’s globally approved marketing applications inclusive of generating high quality and compliant CMC regulatory submissions (Module 2/Module 3) for marketing applications.

This position will report to the Associate Director, Regulatory CMC and can be performed remotely within the US.

What You’ll Do:

• Collaborate with CMC cross-functional team members to plan, write, and review CMC sections of pertinent global regulatory submissions (e.g., marketing and post-approval applications, annual reports, responses to Health Authorities).
• Provide regulatory guidance to cross-functional team members on required post-approval content of Module 2/Module 3.
• Review documentation in support of CMC and QA activities for small molecule commercial programs.
• Review and assess proposed CMC changes for global regulatory impact and post-approval filing requirements.
• Communicate with regulatory Health Authorities on project related matters as needed.
• Provide insight and guidance on implementation of current global regulations with respect to the preparation and submission of CMC regulatory documentation.

Qualifications

What You’ll Bring:

• B.S. in a scientific discipline required (degree in Chemistry strongly preferred); advanced degree a plus.
• Must have 3-5 years pharmaceutical industry experience (small molecule) in CMC Regulatory Affairs. Direct experience with global commercial programs strongly preferred.
• Previous experience in either manufacturing, analytical laboratory, or GMP QA preferred.
• Experience in leading the preparation of high-quality CMC regulatory submissions (Module 2 and Module 3) for global marketing and post-approval applications.
• Strong knowledge in global regulatory (FDA, EMA, ICH) guidelines, knowledge of cGMP.
• Previous experience assessing change controls for global impact and developing regulatory strategies to implement assessed changes globally.
• Previous experience leading/supporting interactions with health authorities a plus.
• Proven ability to manage multiple projects, identify, and resolve regulatory issues.
• Attention to detail and ability to work independently as well as part of a team environment.
• Excellent organizational and communication skills, both written and verbal.
• Strong interpersonal skills and the ability to effectively work cross functionally with others.

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Job Description

The role of Associate Director Market Access – International is to develop and lead execution of Market Access Strategies for the defined scope of countries, in line with International Market Access Strategy for all current and future products that Deciphera plans to place in the market. As such, the main goal of this role is to secure and maintain patient access to existing and future Deciphera products in Europe focusing on France and Italy and potentially additional regional or international responsibilities.

The Associate Director Market Access International reports to the Head of Market Access International and works closely with Global, Regional and Local cross functional stakeholders (e.g.., medical, commercial, regulatory) to ensure successful implementation of the pricing & reimbursement processes in the individual countries as well as successful implementation of international market access strategy.

Key Responsibilities:

• Develop and implement regional and country pricing and access strategies of high quality and fit for purpose to be executed at countries in scope
• Ensure development of deep country-level understanding of payer needs, decision-making approaches, strategies, and country reimbursement stakeholders and influence map
• In collaboration with country General Managers, lead and own the local pricing & reimbursement processes in individual markets against the background of local health care regulations
  • Coordinate and lead of reimbursement dossiers
  • Coordinate and lead of price negotiations with the respective local authorities
  • Secure timely submission and follow-up of P&R submissions with the authorities
  • Organize and coordinate internal expert committees for development or adaptation of market access strategies or health economic models as well as for tackling market access questions from authorities.
  • Ensure evidence synthesis activities (systematic reviews, indirect comparisons, dossier development, etc.) are performed to optimally to meet local payer needs and support successful product positioning
• Support the development of health economic analyzes required for patient access, in collaboration with internal cross-functional teams in medical and HEOR
• Identify and drive additional evidence needs through RWE generation activities
• Provide input to clinical development on the fit of the study designs to address key local payer / HTA requirements in Europe
• Support the execution of broader market access goals, including pricing targets, revenue targets, access timelines, and overall launch success of Deciphera products
• Update regularly local and global cross functional teams on environment changes and potential consequences, proposed strategies and ongoing activities related to market access responsibilities in the region. Monitor external HTA developments and actively provide input to internal HEOR developments.
• Ensure appropriate vigilance on external developments that may impact market access outcomes and update the relevant cross-functional teams
• Establish strong, reliable, and regular relationships with the relevant public health authorities
• Support high-level corporate visits and events that take place in internationally and in Europe and work in collaboration with necessary functions
• Train field teams in market access specific questions as necessary for proper communication with the medical experts
• Lead development and trainings of International Value Communication Plan to ensure product value propositions will be recognized by relevant stakeholders
• Develop and monitor intelligence on the market access landscape in Europe and internationally with respect to Deciphera and competition access, healthcare system changes, HTA developments and general trends in the field
• Establish and drive actions and tactics based on the International Market Access & Pricing vision, modus operandi, and strategy to deliver on International Market Access & Pricing goals and ambition
• Ensure local and regional EU and international Market Access Plans have aligned strategic direction with Deciphera vision and goals
• Participate and represent Deciphera in external industry platforms and trade associations
• Establish and maintain local stakeholder mapping and management tools and workflow utilizing own established local network to best position Deciphera for obtaining local insights and influence policy and access related changes.
• Collaborate closely with critical functional areas internationally and in Europe (Commercial, Medical Affairs, Regulatory, Legal) as well as with affiliates to drive aligned actions and tactics for public policy and access

Qualifications

What You’ll Bring:

• University degree, MBA or PhD in science and/or economics preferred
• At least 6 years of biotech/pharmaceutical/consulting experience in a reimbursement/market access related role with proven footprint in key European countries (especially TC – France, AIFA Italy, etc.)
• Demonstrated experience supporting the regional launch of innovative therapies; oncology or rare disease experience is a plus
• Hands-on experience with country pricing negotiations; demonstrated knowledge of pricing trends, tactics, and European payer dynamics
• Demonstrated knowledge in at least one of the core market access domains (pricing, HEOR, policy, local market execution)
• Experience and proven success working with cross-functional teams across geographies
• Demonstrated success in managing multiple activities (both “self” and through delegation) and working in a fast-paced environment
• Ability to see the ‘bigger picture’ in market access and work across domains
• Ability to manage ambiguity, frequent change, and senior level engagements; Ability to confidently seek out help when needed
• Ability to work across cultures, languages, and geographies and willingness travel frequently, as the business requires

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Job Description

Essential Duties and Responsibilities:

Deciphera is seeking a Director, Field Access (DFA) to join our US Market Access Team. The DFA is a strategic customer facing leader with the core responsibility to ensure coverage and create access for Deciphera’s oncology therapies with national and regional payer accounts, specialty pharmacies, specialty distributors, and oncology GPOs.

The DFA will develop and maintain key customer relationships, execute account plans for targeted national payers, an oncology GPO, and will coordinate case management with the sales team and internal partners. The DFA may serve as the primary point of contact for channel partners.

The DFA will collaborate with the patient support services center, Territory Managers, and Regional Business Directors to ensure minimal barriers to product access for patients and providers.

Key Responsibilities:

• Access: Ensure patient access by building relationships and formulating strategies at aligned payer accounts and oncology practices.
• Customer Relationships: Leader with management of key customers. Develop and cultivate relationships with clinical, medical, pharmacy, policy, and Industry Relations contacts within targeted MCOs, PBMs, oncology GPOs, specialty pharmacies, specialty distributors, and provider offices.
• Account Projects: Independently lead account projects/initiatives addressing changing customer and market requirements, present business cases for opportunity evaluation, and coordinate/manage project implementation.
• Communication: Communicate with Marketing, Territory Managers, and Patient Services team regarding account-specific programs, activities, and pull-through messages.
• Problem Solving: Leader and partner with the sales team, patient hub, and Specialty Pharmacies to support accounts with reimbursement issues and patients facing insurance delays. Use problem-solving skills to address concerns at both the system and individual case level.
• Issue Identification: Identify issues and challenges with payer and provider accounts. Engage appropriate resources for developing customer solutions and contracts.
• Presentations: Deliver presentations on disease state, clinical, economic, access, and business topics effectively.
• Account Plans: Develop goals and account plans aligned with US Market Access strategies. Execute comprehensive initiatives including financial analyses, strategy recommendations, and business plan development.
• Market Access Objectives: Meet or exceed Market Access objectives and manage the optimization of product formulary and reimbursement positioning.
• Travel: Role involves significant travel (up to approximately 50% of time). The DFA will meet with payer customers channel partners, attend conferences, and coordinate with sales and regional colleagues to engage key providers and influencers.

Qualifications

• Education: BS/BA degree in business, life sciences, or related discipline. Advanced degree preferred (e.g., MBA, MPH, NP, PharmD, PhD).
• Pharmaceutical Experience: Ten or more years of experience in the pharmaceutical or biotechnology industries, with demonstrated cross functional leadership.
• Learning Mindset: Ability and willingness to adapt and excel in new environments where the work or tasks may be unfamiliar. 
• Payers: Seven or more years direct experience managing national and regional payers review newly approved drugs. Deep, broad, and measurable payer relationships and understanding of the legislative environment and the respective impact to patient access.
• Specialty Pharmacies & Specialty Distributors: Understanding of the operations and role of SPs/SDs in managing the journey of patients with rare disease.
• Launch Experience: Experience with product launches; establishing coverage and formulary acceptance of oral oncolytic or rare/orphan diseases.
• Communication Skills: Excellent written and verbal communication skills.
• Results-Oriented: Demonstrated ability to deliver results in competitive markets.
• Commercial Functions: Demonstrated success or understanding of multiple commercial functions (e.g., marketing, market access, sales, insights/analytics).
• Team Player: Authentic, humble, professional, able to build positive team spirit, and lead through the ups and downs of drug development. Supports team success and growth.
• Cross-Functional Influence: Skilled at influencing cross-functional teams and interfacing with internal and external stakeholders across commercial and medical/clinical teams.
• Adaptability: Ability to work effectively at multiple levels within the organization and adapt to changes in the work environment. Manages competing demands, changes approach as needed, and handles frequent changes, delays, unexpected events, or uncertainty with maturity and professionalism.

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Job Description

We are seeking a Medical Science Liaison (MSL), field-based scientific/clinical experts that will report to a Regional Director of MSLs within the Medical Affairs (MA) department. The MSL is a highly trained professional with strong clinical and/or scientific backgrounds who must have excellent communication skills. The MSL is responsible for identifying, developing and managing relationships with current and future Healthcare Providers(HCP’s) in academic and community practices.

This position is available as a remote, field-based position.

What You'll Do: 

• Exchange complex medical & scientific information with the oncology community.
• Develop valued and productive scientific relationships with Key Opinion Leaders (KOLs) and other disease experts.
• Provide medical/scientific presentations to internal & external groups.
• Provide internal Medical stakeholders with feedback and insights from interactions and discussions with HCPs.
• Assist with awareness of company-sponsored clinical trials and investigator-initiated trials (ISTs).
• Provide support at professional meetings, including staffing exhibits, collecting competitive intelligence and developing tools that support the function.
• Adhere to corporate and healthcare compliance guidance in all activities, including those related to clinical trials, scientific interactions with internal and external groups, and responses to unsolicited requests for medical/scientific information.
• Maintain clinical, scientific, and technical expertise in specific therapeutic areas; review scientific journals, attend scientific and key technical meetings.
• Represent the company and Medical Affairs during exchanges with the medical/scientific community.
• Establish and maintain ongoing long-term collaborative peer-to-peer relationships with Oncologists, and other HCPs within their assigned territory.
• Respond to and document unsolicited requests for scientific information for Deciphera’s programs and other products, including those in development.
• Engage with assigned Medical Groups to support their scientific and research needs as consistent with Deciphera’s Medical Affairs strategy.
• Collaborate with publication planning to support development of publications and communications.
• Facilitate investigator interactions with Medical Directors and other internal stakeholders.
• Provide clinical input and training to internal functions within regulatory guidelines.
• Provide support for content development and delivery of clinical presentations at Advisory Boards.

Qualifications

What You'll Bring: 

• PharmD, PhD or RN with advanced degree preferred.
• 5+ years of experience in oncological malignancies, preferred.
• 5+ years of experience as field-based MSL, preferred.
• 8+ years of experience in industry (e.g., biotech/pharmaceutical/medical device company, Contract Research Organization), academic research, or public health preferred.
• Experience with clinical research, publication activities, congress/conference and presenting scientific data.
• Experience functioning as a field-based employee preferred.
• Training and/or knowledge of Good Clinical Practice (GCP) and global regulations
• Ability to effectively build relationships and work with global KOL’s.
• Think strategically; apply knowledge and analytical skills in a highly regulated environment; and align medical and commercial strategies
• Ability to summarize complex information and present in a clear, concise, and scientifically accurate manner to a range of audiences
• Knowledge of ICH guidelines, FDA Drug Regulations with respect to DDMAC, PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, and OIG Compliance Program Guidance for Pharmaceutical Manufacturers.
• Excellent communication skills
• Strong problem solving, decision-making, influencing, and negotiation skills.
• Able to travel up to 70% (including some weekends and overnight)
• Must live within assigned territory

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