Careers

Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage biopharmaceutical company focused on rare muscle disorders.

About the Position

The Clinical Contracts Manager/Associate Director will manage key activities related to the outsourcing of clinical trials with a particular emphasis on vendor outsourcing (CROs and other clinical vendors) and contract and financial management of clinical service providers across multiple studies and global programs within Clinical Development. The candidate is ideally based in MA.

Primary Responsibilities

• Collaborates with Clinical, Legal, other internal stakeholders, CRO(s), and vendors to negotiate confidentiality, ancillary, and vendor master service agreements (MSAs), scopes of work/work orders, and single service provider, consultant, and subcontractor agreements
• Clinical contract expert serving as Clinical, Legal, and CRO liaison for clinical trial site agreements
• Leads or assists in the development of request for proposals (RFPs), assessment, and selection of appropriate vendors, and collating, reviewing, tracking and analyzing vendor quotes and proposals
• Coordinates and manages vendor bid defense meetings and associated follow-up as needed
• Analyzes business practices and market conditions to evaluate bid responsiveness and contract/contractor performance
• Negotiates directly with CROs and clinical vendors to obtain optimal pricing
• Ensures that terms and conditions in vendor master service agreements, study-level contractual obligations, and trial site subject informed consent form templates align
• Routes contracts for approval, signature, and filing and creates purchase orders according to companies processes and systems
• Stays current with industry best-practices developing and implementing policies, procedures, and tools to standardize workflow and manage risk
• Participates in the development and improvement of departmental processes and procedures
• Maintains and ensures up-to-date documentation and records, performing periodic reconciliation of all active contracts with vendors
• Other related tasks as needed

Requirements:

• Senior level industry professional with 8+ years experience in contracts management, the majority of which has been in biotech/pharma/CRO and at least 2+ years in small biotech
• Vast knowledge of clinical vendor and trial site agreements in US and globally, including EU and APAC
• Proven strong analytical, negotiating, conflict resolution, and problem-solving skills
• Effective cross-functional collaborator with excellent interpersonal, organizational, project management, time management, and written and oral communication skills
• Ability to multi-task and shift priorities rapidly to meet tight deadlines
• Enthusiastic, self-motivated, and keen to improve processes and overcome any inefficiencies
• Proficient in Microsoft Office suite and applications with an understanding of GrantPlan and benchmarking tools
• Bachelor’s degree required

Salary range: $120,000 – $180,000, title and salary commensurate with experience

Send resume and cover letter to recruiting@edgewisetx.com

Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage biopharmaceutical company focused on rare muscle disorders.

About the Position

Reporting to the Vice President of Discovery and Translational Pharmacology, the Director/Senior Director, Head of Toxicology will be responsible for running Edgewise Therapeutics’ Toxicology program.

Primary Responsibilities

• Design and oversee non-GLP and GLP nonclinical toxicology and safety pharmacology studies to advance our pipeline of small molecule therapeutics for global submissions in adults and pediatric populations
• Works closely with internal groups such as Pharmacology, DMPK, CMC, Regulatory Affairs, Clinical Development, and Project Management, and actively participates in team strategy discussions
• Analyzes, interprets, summarizes, and presents nonclinical safety data to internal teams and leadership
• Authors / reviews safety pharmacology and toxicology sections of global regulatory documents for IND and post-IND stage programs and acts as a nonclinical point of contact for any information requests
• Manage contracts and coordinate activities with CROs; Serve as study monitor

Requirements:

• Ph.D. in toxicology, pharmacology, physiology, biology, or related discipline
• 10+ years of preclinical safety experience in the pharmaceutical/biotechnology industry experience
• Demonstrated expertise in nonclinical study design and management with small molecule drug candidates
• Experience with pre-IND through Phase 1-3 programs and associated regulatory filings
• Excellent communication and presentation skills
• Excellent team management skills

Salary range: $180,000 – $250,000, title and salary commensurate with experience

Send resume and cover letter to recruiting@edgewisetx.com

Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage biopharmaceutical company focused on rare muscle disorders.

About the Position

Cardiovascular leadership position for a proven scientist in the field capable of both performing and leading and in vivo scientific efforts. Broad range of responsibilities, including designing, managing, and leading scientist to perform high-quality experiments, establishing, and managing collaborations, analyzing and reporting data, and contributing intellectually to scientific research as it relates to advancing company goals. The right candidate may lead the in vivo function and be responsible for leading a project team. This position will be based in Boulder, Colorado.

Primary Responsibilities

• Independently design, manage, and execute experiments in context of scientific goals across the company’s ongoing pharmacology projects
• Manage internal and external teams that conduct detailed and complex wet laboratory experiments with appropriate technique and adequate controls satisfactory to substantiate/replicate results
• Contribute to the coordination and direction of research among the company’s scientific disciplines as they relate to assigned projects
• Manage a group of independent researchers
• Research and identify new opportunities and project ideas that complement the company’s mission, vision, values, and goals
• Establish appropriate objectives in the formulation of successful project strategy
• Influence the direction of company programs by designing experiments and collaborations, interpreting, analyzing, and correlating data from multiple sources, overcoming obstacles, and delivering results within project timelines
• Demonstrate a high level of resourcefulness through exceptional scientific knowledge and superior technical skills
• Actively increase team or group performance by critically reviewing work processes while offering insightful input and suggestions
• Produce and review individual and team scientific reports/presentations for internal and/or external purposes
• Work closely with consultants and collaborators to understand results and how they impact project goals
• Demonstrate a strong level of participation and/or lead at project team meetings
• Contribute advanced-level scientific perspective to patent efforts
• Update job knowledge by attending scientific meetings; participating in educational opportunities; reading professional publications; maintaining professional networks; and participating in professional organizations
• Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures

Requirements:

• Ph.D. in cardiovascular physiology or closely related field; post-doctoral and industry experience required
• 10+ years of academic/research laboratory experience
• Exceptional understanding of scientific literature in respective area of science/research
• Demonstrated cardiovascular expertise (publication track record)
• Technical expertise in both in vitro and in vivo cardiovascular techniques across a range of species, with strong molecular and multi-omics expertise.
• Demonstrated ability to work independently and to lead independent scientists.
• Familiarity with safe and efficient laboratory practices/li>
• General scientific computer and software application proficiency

Salary range: $210,000 – $275,000, title and salary commensurate with experience

Send resume and cover letter to recruiting@edgewisetx.com

Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage biopharmaceutical company focused on rare muscle disorders.

About the Position

This position provides regulatory expertise from preclinical through clinical development for our cardiac programs. Broad range of responsibilities include managing the development of regulatory strategy and submissions. The right candidate will provide oversight and regulatory expertise to support the development team with moving innovative investigational therapies through clinical development.

Primary Responsibilities

• Oversees the writing, editing, reviewing and compiling documents needed for regulatory submission activities for US and global assigned products
• Provides critical review of all documentation supporting regulatory submissions and communications
• Prepares and submits regulatory applications, annual reports/IND amendments, and meeting requests to FDA and other regulatory agencies
• Reviews and prepares responses to requests from regulatory authorities
• Provides leadership for regulatory document management systems and maintains corporate regulatory files
• Ensures regulatory milestones are met to support regulatory submission and overall business goals of the Company
• Contribute to the development of regulatory strategies
• Research and identify new opportunities outside of assigned work that augment Company’s mission, vision, values, and goals
• Effectively manages and mentors regulatory staff
• Oversees assigned external vendors and contractors with responsibility for providing regulatory support functions to ensure goals are achieved
• Primary liaison with regulatory agencies and interacts with senior management to report on project or program milestones
• Provides strategic or operational input on project team
• Builds professional and effective external relationships crucial to the success of the organization
• Works across internal departments to maintain credibility, trust, and support of employees and other stakeholders
• Fully involved and responsible for all areas of communication with FDA and other government regulatory authorities
• Other duties as assigned

Requirements:

• BS/BA degree in a scientific/health sciences discipline
• 10+ years experience in pharmaceutical Regulatory Affairs
• Experience in cardiology preferred
• Experience in the preparation of submissions, regulatory documents, annual reports, amendments and supplements
• Proven ability to strategize with team members on the optimal way of documenting various submissions and determining the preferred plan
• Management expertise on the timeline and process for submissions
• Expert knowledge of regulations and guidance’s affecting routine regulatory activities and specific therapeutic areas and keeps abreast of the regulatory environment
• In-depth knowledge of overall global drug development
• Excellent written, interpersonal and communication skills
• Action oriented and committed to meeting FDA and other regulations while moving projects forward
• Able to handle changing priorities and multidisciplinary tasks
• Easily gains trust and support of peers; encourages collaboration
• Strong project management skills

Salary range: $170,000 – $260,000, title and salary commensurate with experience

Send resume and cover letter to recruiting@edgewisetx.com

Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage biopharmaceutical company focused on rare muscle disorders.

About the Position

Edgewise Therapeutics is seeking an experienced, highly collaborative, and action-oriented leader for a development position with a broad range of duties, overseeing all aspects of the clinical operations for the company’s cardiovascular therapeutic area. This position provides strategic operational guidance to ensure that programs are properly defined, planned, and executed to deliver on the clinical development plan.

Primary Responsibilities

• Strategic planning of clinical trials, resourcing, and providing oversight/execution to achieve program objectives and high quality deliverables within established timelines and budgets
• Establish, implement, and proactively manage clinical trial processes, strategic outsourcing and performance indicators (in collaboration with existing clinical operations leadership) in order to conduct multiple clinical trials in early to late stage to achieve corporate objectives
• Collaborate with Quality on company SOPs that ensure high standards for compliance ICH-GCP guidelines, governing regulations and patient safety standards
• Create and monitor timelines for patient screening and enrollment
• Ensure successful internal trainings are conducted, and project, and organization goals are met
• Work with the Clinical Development Team to optimize retention of patients under clinical study
• Draft or help develop clinical study protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents including clinical study reports; draft or help compose the clinical contribution to IND’s, Investigational Brochure, regulatory Briefing Documents, and other relevant documentation
• Oversee all operational aspects of clinical data management including adverse event reporting, study site selection and training, budget management and contract review
• Contribute to authoring and review regulatory submissions and scientific data disclosures as required
• Identify, evaluate and lead the selection of CROs appropriate to conduct initial and subsequent Phase 1 and 2 clinical trials; provide supervision, oversight and direction to engaged CRO’s
• Identify, select, and monitor investigational sites for Phase 1/2 and 3 clinical studies; prepare accurate and timely visit reports from all site visits
• Work with CRO’s, study sites, investigator staff and Regulatory Affairs function to ensure the acquisition and maintenance of appropriate IRB and related approvals
• Provide continuous assessment and alignment of the clinical operations functions to ensure efficiency, effectiveness, and quality-by-design in operational execution
• Accountable for establishing and maintaining inspection readiness across programs in collaboration with Quality Assurance
• Develop, negotiate, and manage the clinical operations budget for cardiovascular
• Provide strategic operational guidance to ensure that trials are properly defined, planned, and executed across all clinical stage programs
• Responsible for leading and managing cardiovascular clinical operations, allocating and directing internal resources and effectively utilize outsourcing to achieve project and business goals in a timely manner
• Responsible for leading and/or guiding creative and constructive interactions with clinical sites to ensure that all new cardiovascular clinical trials and programs have clearly defined plans/strategies and milestones
• Directs initiatives that accomplish continuous improvement and cost effectiveness to enhance operational efficiencies, product safety and GCP compliance and standardization of processes and procedures (e.g., GCP quality systems, SOPs/guidance, document management systems, etc.)
• Coordinates and directs outsourcing activities across program(s) and oversees the clinical trials budgets
• Identifies program/resource gaps; devises and implements solutions
• Works with teams to ensure regular & high-quality enrollment and program updates are provided to Senior Management
• Provides strategic input to project risk analysis and solution development to a variety of complex problems
• Remains current with medical developments and publications on similar and competitor products. Applies this knowledge to current programs
• Mentors and develops cardiovascular clinical operations staff as needed
• Works collaboratively across a broad range of people developing and maintaining good working relationships in order to facilitate a team-based approach to meeting the company's objectives

Requirements:

• A minimum of 15 years Pharmaceutical development experience moving product candidates from Phase I through pivotal, with at least 8 years managing CROs is required Must have working knowledge of clinical research design principles, GCP/ICH requirements, and regulatory/safety considerations across all phases of clinical development
• Particular experience in IND preparation and filing, Phase 1-2 trials, translational medicine and biomedical imaging preferred
• Demonstrated experience managing clinical operations from pre-clinical through all clinical phases, including managing consultants, contractors, CROs and budgets
• Demonstrated strategic leadership building clinical operations infrastructure, including SOPs, and managing vendors
• Experience developing, implementing and leading a broad range of clinical trials both in the U.S. and ex-U.S
• Willingness and ability to travel domestically and international as required
• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
• Independently motivated, detail oriented and good problem solving ability
• Excellent influencing and communication skills (verbal and written)
• Proficiency in Electronic Data Capture and Clinical Trial Management Systems
• Strong strategic/conceptual skills that can bridge the gap between the scientists and all of the business functions of the Company
• Solid resource management and planning skills
• Must have experience in evaluating, negotiating and managing multiple successful relationships with partners, ability to set up milestones to track progress and working collaboratively with partners to achieve goals
• Leads by example and models team behavior by soliciting opinions but is also willing to make key decisions and is effective in getting the team behind the decisions
• Demonstrated skills in developing and fostering a team-based environment
• Exceptional inter-personal, negotiation, influencing, communication and presentation skills (both oral and written) are required with the ability to interact with colleagues and partners at all levels of experience are expected
• Successful track record of hiring, training, developing, mentoring and motivating team members to the highest level of performance
• Flexibility to travel domestically and internationally, as required
• General computer and software application proficiency
• Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures
• Perform other duties as assigned by supervisor

Salary range: $200,000 – $350,000, title and salary commensurate with experience

Send resume and cover letter to recruiting@edgewisetx.com

Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage biopharmaceutical company focused on rare muscle disorders.

About the Position

The Legal Affairs Counsel will provide general legal support for Edgewise Therapeutics’ R&D operations, primarily by handling a wide range of agreements for both on-going and new discovery and development programs.

Primary Responsibilities

• Provide legal support and substantive advice primarily to Edgewise’s R&D functions, including Discovery, Clinical Operations, CMC and Regulatory Affairs, and secondarily to general and administrative functions of the company, including Project Management, IT, and Finance.
• Draft, review, negotiate, and interpret a high volume and wide range of agreements, including confidentiality, material transfer, services, consulting, sponsored research, clinical trial and investigator-initiated trial agreements.
• Identify, develop and implement business process improvements to enhance delivery of legal support for transactions and related business decision-making.
• Identify training needs within client groups and assist in the development and presentation of training on relevant laws, regulations and legal/business issues.
• Maintain frequent contact with all client functions within the company, managing requests and prioritization of projects.

Requirements:

• JD degree from an accredited law school.
• Excellent academic and law firm credentials.
• Must have 3-7 years of relevant prior experience handling complex commercial contracts at a law firm with a nationally recognized Life Sciences/Pharma/Biotech practice or in-house at a pharma/biotech organization.
• Science background a plus.
• Must be licensed to practice law in at least one (1) state and in good standing.
• Significant experience drafting, reviewing, and negotiating a wide variety of complex pharma-related agreements.
• Excellent skills in verbal and written communication, with ability to distill complex legal issues to essential elements for clients throughout the organization with different abilities and responsibilities.
• Strong organizational skills in order to prioritize and manage multiple time-sensitive projects simultaneously; willingness to assume heavy workload to meet timing and project needs.
• A demonstrated ability to grasp scientific and technical concepts quickly.
• Ability to collaborate, as well as work independently, balancing competing priorities.
• Strong client-support skills.
• Attention to detail.
• High business acumen with the ability to appropriately balance legal and business risks in an ethical and compliant manner.

Salary range: $120,000 – $200,000, title and salary commensurate with experience

Send resume and cover letter to recruiting@edgewisetx.com

Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage biopharmaceutical company focused on rare muscle disorders.

About the Position

Edgewise Therapeutics is dedicated to advancing small molecule drug development programs focused in rare muscle disorders. The Manager, Clinical Drug Supply Chain is responsible for forecasting Investigational Product (IP) supply requirements for multiple clinical trials and for managing the IP distribution process to one or more clinical trials. Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities’ regulations / guidelines. Contributes to ongoing process improvement initiatives. Collaborates and interacts with clinical trial managers, as well as staff from quality, clinical compliance, regulatory, and (CMC, external manufacturing, stability).

Primary Responsibilities

• Serves as lead drug supply manager in supply planning, including demand forecasting according to clinical development requirements.
• Leads supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan.
• Provides input to the development of IP-related study documents including protocols, study, and pharmacy manuals.
• Is responsible for working within established timelines of investigational product manufacturing, labeling, release, distribution, and return/destruction, and/or helping to establish these timelines.
• Is responsible for investigational product (IP) inventory strategy; advises supply management team of potential shortages and defines resupply activities based on usage trends and projections.
• Has a solid understanding and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS.
• Works with cross-functional teams to develop specifications and support user testing of IRT systems provided by 3rd party vendors.
• Leads effort for clinical supply management functionality.
• Monitors clinical supply activities through IRT from study start-up through study closure.
• Develops strategy and oversees drug return and destruction activities.
• Develops resupply strategies based on stability and shelf-life of clinical supplies.
• Monitors IP expiry data and informs Clinical Trial teams of pending IP expiry.
• Coordinates with other functional areas, to define ancillary and/or comparator supply strategy.
• Provides feedback to drug kit randomization specifications and reviews and approves master kit lists.
• Designs, reviews, and approves IP-related study tools (for clinical study teams and investigative site use), as needed.
• Provides input into budgets, SoWs, contracts, and timelines for IP-related services.
• Creates RFPs, reviews quotes, and awards third-party vendors for distribution services.
• Responsible for distribution vendor budget management (invoice review/approval, change orders, reconciliation); reviews and approves/scrutinizes specified costs on vendor invoices against contract, as delegated.
• Leads management of IP service vendors (performance, quality, timelines, results, costs).
• Participates in preparation of RFP, assumptions, and SOW for CROs and IP services vendors (labeling, packaging, distribution; IVRS/IWRS).
• Provides input, reviews, and approves vendor study specifications for IP-related activities.
• Serves as point of escalation for vendor-related IP issues as they arise.

Requirements:

• Bachelor's Degree or at least 5 years of relevant experience in the biotechnology/pharmaceutical industry, with 3 years minimum in clinical supply management.
• May require up to 10% travel.

Salary range: $70,000 – $140,000, title and salary commensurate with experience

Send resume and cover letter to recruiting@edgewisetx.com

Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage biopharmaceutical company focused on rare muscle disorders.

About the Position

Edgewise is seeking a synthetic medicinal chemist, eager to contribute to the discovery of novel small-molecule drugs. As a Senior Scientist in Medicinal Chemistry, you will work as part of an interdisciplinary team of scientists to discover novel small molecule therapeutics. You will be responsible for the design and synthesis of novel compounds for ongoing and emerging projects and identification and application of SAR to compound design. You will work in a team-driven environment to achieve optimization of clinical candidates. Responsibilities may also include management of CRO-driven collaborations, work with the CMC team on translation to large scale chemistries of successful candidates, and contribution to patent and publication preparation.

Primary Responsibilities:

• Utilize synthetic organic chemistry to investigate, identify, develop, and optimize methods
• Initiate and execute the design, synthesis, purification and characterization of organic small molecules via multi-step synthesis
• Propose and explore alternative synthetic routes and synthetic strategies, troubleshoot reactions and multistep reaction sequences
• Generation of new scientific synthetic and medicinal chemistry proposals for lead optimization efforts
• Lead the development, execution and/or contribute ideas for novel small molecules based on SAR, X-Ray crystallography and scientific literature
• Oversee and effectively manage CRO chemists
• Interact with vendors to meet program requiements
• Maintain close collaborations and/or manage and mentor fellow chemists and researchers across disciplines in a team environment
• Maintain a command of relevant scientific literature and incorporate into individual project(s) as well as the overall program
• Engage in medicinal chemistry discussions and drive decision-making on compounds
• Prepare and present research results in chemistry and project team meetings and deliver scientific presentations and data to colleagues within and outside the company
• Maintain clear, detailed, and up-to-date records of research using electronic laboratory notebooks
• Manage internal scientific databases

Requirements:

EDUCATION, EXPERIENCE, SKILLS:

• Degree in Organic Chemistry with a focus on modern synthetic organic chemistry with typically, 8+ (BS) or 5+(MS) years of experience; Pharmaceutical industry experience desirable
• Understanding of ADME, physicochemical properties, and principles of medicinal chemistry
• Skilled in the art and practice of modern synthetic and mechanistic organic chemistry with demonstrated experience in designing and executing multistep synthesis of complex organic molecules
• Competence with the use of modern spectroscopic methods applied to structure determination including 1H NMR, 13C NMR, IR and mass spectroscopy
• Demonstrate the ability to resolve key scientific hurdles by effectively utilizing available information and technical expertise
• Exceptional communication skills; ability to develop, implement and clearly communicate chemistry strategies and progress to team
• Build strong relationships with peers and cross functionally with partners outside of teams to enable high performance
• Self-motivated with the ability to work independently and effectively in a team-oriented, multidisciplinary environment
• Familiarity with safe and efficient laboratory practices
• General scientific computer and software application proficiency

Salary range: $85,000 – $150,000. Salary will depend on experience level.

Send resume and cover letter to recruiting@edgewisetx.com

Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage biopharmaceutical company focused on rare muscle disorders.

About the Position

Edgewise Therapeutics is seeking an experienced, highly collaborative, and action-oriented leader to lead the Global Cardiovascular Medical Affairs team. Partnering with cross-functional stakeholders, this individual will identify and integrate the unmet needs and perspectives into product and Franchise Medical Affairs strategies with a focus on external stakeholder engagement and information sharing, and the tools to support both.

You will guide the company’s Cardiovascular efforts in several areas: Scientific Communications (Publications/Data Dissemination), RWE and HEOR, Medical Communications (Congress planning, Advisory Boards, Medical Education), KOL Strategy and Development as well as eventual MSL team buildout and leadership. Given the importance of direct patient and clinician input into our work to inform us of their unmet needs and for them to be aware of the groundbreaking science being developed at Edgewise, the person in this role will also engage externally and build trusted relationships with Thought Leaders, Patient Advocacy Groups, and Scientific Societies through scientific exchange and education/research partnerships.

The senior leader, Cardiovascular Medical Affairs will have a strong understanding of all phases of product development, including preclinical development, clinical trial management, post-launch marketing, post-approval studies, regulatory affairs, GCP and manufacturing compliance. As a critical member of the Cardiovascular Development Team, this person will work closely with the leaders of Clinical Science and Development Operations to lend their own expertise to the introduction of investigations of our potential therapeutics into the clinic, and assist with the dissemination of information about these studies.

Primary Responsibilities

This function is responsible for building strategic medical communications and evidence-based content and information resources in collaboration with the CDO. The Senior Leader of Medical Affairs will be responsible to work cross functionally with scientific leaders to manage the publication process and scientific congress planning, and contribute to a broad range of Medical Affairs activities, both internally and externally facing content, including the support of Medical Information and KOL mapping related activities until designated functions are built out.

Job responsibilities: 

Lead, and as appropriate to the progress of clinical development programs, build a world-class global Cardiovascular Medical Affairs function and infrastructure. This will include cross-functional interactions with existing personnel in Musculoskeletal Medical Affairs and hiring qualified functional leaders and/or consulting with external support to implement and execute the medical affairs strategic plan.

• Cardiovascular Scientific Communications:
  •  Create the process, plan, and manage the development and submission of medical and scientific publications (including abstracts, posters, oral presentations and manuscripts) via collaboration with internal and external stakeholders in accordance with timelines as set in publication plans
• Cardiovascular Clinical Development Support:
  • Collaborate internally with clinical and regulatory departments to support the planning, execution, and management of clinical trial activities.
• Cardiovascular Medical Communications:
  • Develop a CV medical communication strategy including Medical Platform statements, lexicon, standard responses, a core scientific education slide library, and competitive intelligence trackers that will serve as the foundation for external scientific exchange and internal training.
  • Drive engagement with internal and external stakeholders to understand communication needs and serve as an expert resource. This will include the establishment, planning, and execution of Scientific and other Advisory Boards.
  • Identify external educational needs and create/execute external educational efforts (Symposiums, CME sessions, etc) to address these deficits in support of CV medical affairs strategy.
• Cardiovascular Field Medical:
  • Identify and build relationships with key external stakeholders including, but not limited to, investigators, healthcare providers, payors, healthcare institutions, professional societies, and advocacy groups.
  • Responsible for the collection of insights and successful dissemination of innovative clinical information to thought leaders, payers, and other key external stakeholders.
• Medical Affairs Operations: (built in collaboration with Musculoskeletal Medical Affairs)
  • Support the development of departmental budget, forecasting, and long-range planning, and tracking operational expenses.
  • Prepare and maintain policies and SOPs to ensure compliant dissemination of medical information
• Cardiovascular Advocacy & Professional Organizations (in collaboration with Patient Advocacy):
  • Oversee engagement with professional societies and industry organizations focused on advancing clinical knowledge, infrastructure, and practice enabling the adoption of precision medicine to improve patient outcomes.
  • Work to infuse the patient perspective and strategic insights from patient advocacy group partners into the business, leveraging existing initiatives – including Patient Councils across core therapeutic areas – and new opportunities to inform and influence strategy from discovery to clinical development to commercialization.

Requirements:

• Advanced science degree with 10+ years of related experience within the pharmaceutical industry. Degree in pharmacy or advanced degree in science/medicine (MD, PhD, MD/PhD, DNP, or PharmD)
• Background in cardiovascular disease and cardiomyopathy ideal
• Self-directed individual with the ability to multi-task effectively and deliver results on-time
• A flexible team player with a no-job-too big or too small attitude, who thrives in a fast-paced and energetic environment
• Strong organizational skills/business planning
• Creative problem-solving skills
• Proven ability to develop and grow productive relationships with external and internal stakeholders in a range of disciplines
• Demonstrated ability to present complex scientific and medical information to a range of audiences
• Ability to critically appraise medical/scientific literature with attention to the strategic needs ensuring alignment with publications plan
• Able to translate corporate strategies and objectives and apply to medical/scientific communications, as appropriate
• Excellent communication skills with an ability to develop collaborative relationships and work effectively with all levels of management
• Excellent presentation skills and experience creating slide deck modules for internal and external communication
• A proven track record of strong writing and reviewing skills that are compliant with legal, requirements, local policies and procedures, including Good Publication Practices
• Ability to effectively manage medical communications agencies and/or freelancers
• Able to identify and manage differences through discussion and agreement, as appropriate
• Demonstrates high ethical and professional standards with all business contacts
• Ability to represent the needs of a broad range of stakeholders in development of real-world evidence strategy and tactics
• Experience developing external and internal engagement and education tools
• Demonstrates expert knowledge and proficiency with general office procedures such as commonly used office software (e.g., MS Office-Word, Excel, PowerPoint,)
• Strong written communication and project management skills
• Ability to work effectively in a fast-paced and ever-changing environment; ability to prioritize and multi-task, and work autonomously as well as collaboratively within cross-functional teams
• Ability to engage in positive dialogues, influence outcomes and resolve conflicts in a constructive manner
• Willingness and ability to travel up to 25% of the time

Salary range: $200,000 – $350,000, title and salary commensurate with experience

Send resume and cover letter to recruiting@edgewisetx.com

Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage biopharmaceutical company focused on rare muscle disorders.

About the Position

Edgewise is seeking a synthetic medicinal chemist, eager to contribute to the discovery of novel small molecule drugs. As a Senior Scientist in Medicinal Chemistry, you will work as part of an interdisciplinary team of scientists to discover novel small molecule therapeutics. You will be responsible for the design and synthesis of novel compounds for ongoing and emerging projects and identification and application of SAR to compound design. You will work in a team-driven environment to achieve optimization of clinical candidates. Responsibilities may also include management of CRO-driven collaborations, work with the CMC team on translation to large scale chemistries of successful candidates, and contribution to patent and publication preparation.

Primary Responsibilities:

• Utilize synthetic organic chemistry to investigate, identify, develop, and optimize methods
• Initiate and execute the design, synthesis, purification and characterization of organic small molecules via multi-step synthesis
• Propose and explore alternative synthetic routes and synthetic strategies, troubleshoot reactions and multistep reaction sequences
• Generation of new scientific synthetic and medicinal chemistry proposals for lead optimization efforts
• Lead the development, execution and/or contribute ideas for novel small molecules based on SAR, X-Ray crystallography and scientific literature
• Oversee and effectively manage CRO chemists
• Interact with vendors to meet program requiements
• Maintain close collaborations and/or manage and mentor fellow chemists and researchers across disciplines in a team environment
• Maintain a command of relevant scientific literature and incorporate into individual project(s) as well as the overall program
• Engage in medicinal chemistry discussions and drive decision-making on compounds
• Prepare and present research results in chemistry and project team meetings and deliver scientific presentations and data to colleagues within and outside the company
• Maintain clear, detailed, and up-to-date records of research using electronic laboratory notebooks
• Manage internal scientific databases

Requirements:

EDUCATION, EXPERIENCE, SKILLS:

• Degree in Organic Chemistry with a focus on modern synthetic organic chemistry with typically, 10+ (BS), 8+(MS) or 4+(PhD) years of experience; Postdoctoral or pharmaceutical industry experience desirable
• Understanding of ADME, physicochemical properties, and principles of medicinal chemistry
• Skilled in the art and practice of modern synthetic and mechanistic organic chemistry with demonstrated experience in designing and executing multistep synthesis of complex organic molecules
• Competence with the use of modern spectroscopic methods applied to structure determination including 1H NMR, 13C NMR, IR and mass spectroscopy
• Demonstrate the ability to resolve key scientific hurdles by effectively utilizing available information and technical expertise
• Exceptional communication skills; ability to develop, implement and clearly communicate chemistry strategies and progress to team
• Build strong relationships with peers and cross functionally with partners outside of teams to enable high performance
• Self-motivated with the ability to work independently and effectively in a team-oriented, multidisciplinary environment
• Familiarity with safe and efficient laboratory practices
• General scientific computer and software application proficiency

Salary range: $100,000 – $175,000. Salary will depend on experience level.

Send resume and cover letter to recruiting@edgewisetx.com