Job Description

The Role:

We are seeking a Medical Science Liaison (MSL), field-based scientific/clinical expert that will report to the Senior Director, MSLs within the Medical Affairs (MA) department. The MSL is a highly trained professional with strong pharmaceutical, clinical 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(HCPs) in academic and community practices.

This position is a remote, field-based position with significant travel required across assigned region.

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. Deciphera prefers the majority of HCP interactions take place face-to-face with some virtual interaction component as well.
• 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 relevant 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.
• Facilitate investigator interactions with Medical Directors and other internal stakeholders.

Qualifications

What You’ll Bring:

• Advanced degree preferred with PharmD, PhD, MD, RN/NP, or PA-C  highly preferred.
• 3+ years of experience in oncological malignancies or other rare disease therapeutic area, preferred.
• 3+ years of experience as field based MSL, preferred.
• 3+ years of experience in industry (e.g., biotech/pharmaceutical/medical device company, Contract Research Organization), academic research, or public health preferred. Clinical experience would be considered in lieu of industry experience.
• Experience with clinical research, publication activities, congress/conference and presenting scientific data.
• Experience functioning as a field-based employee preferred.
• Ability to effectively build relationships and work with KOLs. Significant face to face interactions will be required.
• 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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Job Description

The Role:

We are seeking a senior level, experienced Medical Science Liaison (MSL), field-based scientific/clinical expert that will report to the Senior Director, 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 (HCPs) in academic and community practices. This person will have mentorship and oversight responsibilities within the MSL structure for an assigned portion of the U.S

This position is a remote, field-based position with significant in-person travel required across your assigned region, as well as ride-alongs with other US MSLs in their assigned regions. Role will also include virtual engagement with customers across the US

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. Deciphera prefers the majority of HCP interactions take place face-to-face with some virtual interaction component as well.
• 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 relevant 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.
• Facilitate investigator interactions with Medical Directors and other internal stakeholders.

In addition to the MSL responsibilities outlined above (~70% of role), this expanded role, who will serve as Medical Solutions Lead, will also have additional responsibilities, as designated and assigned by the Sr. Director, MSLs, which may include:

• Lead, in collaboration with the Scientific Directors, the creation of scientific materials for field medical use (proactive and reactive slide decks and other appropriate collaterals for use in scientific exchange)
• Contribute to the execution of congress strategy including assisting with content development for medical booth, non-promotional symposiums, KOL engagement plan.
• Assist with the development and delivery of training materials and programs in collaboration with the DCPH training department and MA leadership to ensure MSLs have appropriate levels of expertise in disease states and with relevant products.
• Assist with curriculum development, onboarding, and continual training of the MSLs, as well as complete field observations/assessments. 
• Aid in the development and execution of top-quality education strategies and activities to provide disease state, mechanism of action, product, and MSL best practices training for the MSL team (i.e. facilitate journal clubs, lead best practice calls etc.).
• Development of MSL-focused slide decks and training modules with assessments on disease state, therapeutic landscape, competitive intelligence, DCPH asset specific data, etc.
• These responsibilities will make up about 30% of role

Qualifications

What You’ll Bring:

• Advanced degree in an appropriate, job-related discipline is preferred, with a PharmD, PhD, MD, RN/NP, or PA-C being highly preferred.
• 5+ years of experience in oncological malignancies or a rare disease therapeutic area, preferred.
• 5+ years of experience as a field based MSL, or similar l MA experience, such as MSL trainer, Senior MSL, Medical Communications/Collateral generation, preferred.
• 8+ years of experience in industry (e.g., biotech/pharmaceutical/medical device company, Contract Research Organization), academic research, or public health is preferred. Clinical experience would be considered in lieu of industry experience.
• Experience with clinical research, publication activities, congress/conference and presenting scientific data.
• Experience creating MSL training materials as well as coaching and training field based MSL teams is a plus.
• Strong experience with PowerPoint, Word, and Excel; must be able to create and edit content with minimal assistance and an eye for accuracy and detail.
• Experience with Veeva CRM (or other CRM) and Veeva Vault, as well as SharePoint and/or BOX is preferred.
• Ability to effectively build relationships and work with KOLs. Significant face to face interactions will be required.
• 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.
• While there is a virtual component of this position, must be able to travel up to 70% (including some weekends and overnight), in assigned region as well as across US as needed; monthly travel to Waltham HQ is expected.
• Must live within assigned region.

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Job Description

The Role:

We are seeking a Medical Science Liaison (MSL), field-based scientific/clinical expert that will report to the Senior Director, MSLs within the Medical Affairs (MA) department. The MSL is a highly trained professional with strong pharmaceutical, clinical 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(HCPs) in academic and community practices.

This position is a remote, field-based position with significant travel required across assigned region.

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. Deciphera prefers the majority of HCP interactions take place face-to-face with some virtual interaction component as well.
• 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 relevant 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.
• Facilitate investigator interactions with Medical Directors and other internal stakeholders.

Qualifications

What You’ll Bring:

• Advanced degree preferred with PharmD, PhD, MD, RN/NP, or PA-C  highly preferred.
• 3+ years of experience in oncological malignancies or other rare disease therapeutic area, preferred.
• 3+ years of experience as field based MSL, preferred.
• 3+ years of experience in industry (e.g., biotech/pharmaceutical/medical device company, Contract Research Organization), academic research, or public health preferred. Clinical experience would be considered in lieu of industry experience.
• Experience with clinical research, publication activities, congress/conference and presenting scientific data.
• Experience functioning as a field-based employee preferred.
• Ability to effectively build relationships and work with KOLs. Significant face to face interactions will be required.
• 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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Job Description

The Senior Manager, Pharmacovigilance Operations encompasses a key leadership role in providing direction to the Pharmacovigilance department for adverse event case management, support of study teams and projects, oversight of maintenance of drug safety database, and collaboration to support risk management and pharmacovigilance for all Deciphera Pharmaceuticals Clinical Trials and post marketing (where applicable). 

What You’ll Do: 

• Responsible for performing critical safety vendor oversight to ensure all pharmacovigilance activities are performed in an efficient, consistent and compliant manner 

• Accountable for coordination of day-to-day operational ICSR activities in collaboration with designated management personnel at the vendor site(s). Review incoming adverse events to determine action required 

• Provide oversight and review of vendor case processing and submission activities by external vendor, including the review and monitoring of compliance through various monitoring reports and other oversight activities. Manage Vendor Oversight including tracking of KPIs, metrics and QC of SAE / ICSR cases in Safety database 

• Responsible for facilitation of training, including training GVP Modules and key relevant US & EMA safety-related Guidance documents and procedures 

• and development of vendor personnel (remotely and on-site at the vendor site) as required, driving the development of self-sufficiency at the vendor 

• Lead Deciphera Pharmaceuticals PV Operations in ensuring all safety reports received from all clinical trials are processed in a consistent and a fully compliant manner. Manage SAE / SUSAR reporting activities for all investigational drugs (Maintain oversight to ensure Global clinical trials case reporting process is efficient and compliant with reporting requirements) 

• Oversee maintenance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events from Deciphera Pharmaceutical clinical trials 

• Provide direct technical /data management support to ensure information entered and retrieved from the safety database is consistent, accurate and complete in accordance to data requests. Performing and contributing to safety monitoring and signal detection activities for products including signal identification, evaluation, interpretation of safety signals and prioritizing signals for full evaluation and communication of safety risks. Perform ad hoc analyses as required 

• Ensure Global clinical trials case reporting process is efficient and compliant with reporting requirements detailed in the safety management plans (SMP) / PV agreements 

• Support the oversight and management of global business partner safety data exchange agreements/ pharmacovigilance agreements and other contracts as applicable to ensure compliance with data exchange activity. Communicates with partner companies and vendors regarding processing and timely exchange of safety data. Distributes aggregate reports as required and assists with reconciliation activities. 

• Develop and maintain Medical Safety and Pharmacovigilance related documents including Safety Management Plans, SOPs and Work Instructions, and Safety Data Exchange Agreements. 

• Lead preparation of safety-related plans with partners and CROs 

• Provide guidance and support to project teams for safety-related areas, including protocol development and study conduct 

• Work cross functionally with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory safety reporting guidelines and implementing relevant guidelines into Deciphera practices and procedures. 

• Contribute to preparation of relevant safety sections of clinical study reports, annual reports, expedited safety reports and other regulatory filing documents 

• Assist as needed with the preparation and updates to Investigator Brochures, DSURs, Protocols, ICFs, IBs (including RSI determination), CSRs, CCDS, RMP, REMS etc. 

• Assist with response to safety-related queries from regulatory authorities or Ethics Committees, if needed 

• Collaborate to ensure alignment among case handling, aggregate reporting, and signal detection activities 

• Assist with the ongoing review TFLs and AE data from ongoing studies to evaluate common AEs, lab abnormalities, and summarize the results in the product safety reports in support of regulatory submission activities, signal detection and management activities, or in response to ad hoc safety inquiries from health authorities, track all safety related activities 

• Support the development of Deciphera Pharmaceutical PV infrastructure, including new safety projects and set-up of safety systems applicable to safety data from the medical and scientific perspective 

• Oversee deviation and CAPA activities in relation to, but not limited to, late SUSAR or aggregate report submissions as well as deviations relating to case management processes as defined per the SMPs or SOPs 

• Adhere to company policies and applicable regulations including reporting of adverse events to regulatory agencies 

• Other duties as assigned 

Qualifications

What You'll Bring: 

• Education: Bachelors/Advanced degree preferably in life science, nursing, pharmacy or other healthcare related profession (MD, RN, PharmD, NP, PhD, MPH, etc.) 

• 6+ years of direct pharmacovigilance work experience in the pharmaceutical industry 

• Experience with Argus Safety database is a must 

• Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines) 

• ICSR submission experience is highly preferred 

• Knowledge of MedDRA and WHO Drug dictionaries 

• Experience with overseeing and managing vendors 

• Experienced in pre- and post-approval pharmacovigilance activities, including safety reporting 

• Solid clinical knowledge and strong analytical ability to review, evaluate, interpret, and synthesize clinical and safety data 

• Strong proficiency in verbal and written communication; great attention to detail, ability to meet project deadlines 

• Ability to work independently, to manage work priorities, to build collaborative team relationships at all levels and remain flexible to the needs of the teams / projects. Must be able to work on multiple projects simultaneously 

• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures 

• Proficient in standard computer software (Word, Excel and Power point presentations) 

• Previous experience and formal training with safety database programs including configuration and validation activities is 

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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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