Allakos jobs

Senior Specialist, Quality Assurance Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients' lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients. Your Role: Perform master batch record review and executed batch record review. Support activities for dispositioning clinical and commercial bulk drug products and finished drug products. Support the change management process, ensuring compliance with cGMP. Assist in quality investigation of manufacturing/packaging deviations. Assist in GMP audits, as required. Assist in supplier qualification and reassessment activities. Support the QA review of internal and external documentation for compliance with approved documentation, established standards, and regulations. Review and updates GMP related SOPs and policies Participate in projects that support continuous improvement efforts. CMO oversight of packaging contractors. Support manufacturing and packaging validation activities as well as commercial launch activities. Participate in interactions with external service providers, as applicable. Some travel is required, domestic and international. Qualifications and Expertise: At least 4 years of relevant experience in the area of quality assurance in the Biotech/Life Sciences arena Bachelor's degree or higher Working knowledge and understanding of ICH, FDA, and EU regulations Working experience in GMP environment. Excellent communication skills, both oral and written. Excellent interpersonal skills, collaborative approach essential. The salary is competitive and commensurate with experience and qualifications. The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City. About This Role Axsome Therapeutics is seeking a Regional Marketer (RMK) to be a field-based extension of the Migraine Marketing team that will focus on commercial KOL engagements with CNS experts to gain insights into national, regional, and local opportunities, provide a bridge between regional markets and headquarters, and regionally support the brand strategy and inform strategic direction. Additionally, the RMK will lead Peer to Peer speaker development, training, and support the execution of promotional programs and national and regional congress activity. This role will liaise with other field-based leaders, within approved SOPs, including but not limited to Field Medical, Sales, Training, as well as Corporate based colleagues in Marketing, Sales, Market Access, Market Research, and Medical Affairs, as appropriate. Additionally, the RMK will help develop and execute HCP marketing initiatives in line with brand strategies and objectives. This individual will report to the Senior Director, Regional Marketing for Neurology. This is a field-based position in the West Region that includes WA, OR, CA, NV, ID, MT, WY, UT, AK, HI. Candidates must live in the geography. Job Responsibilities and Duties include, but are not limited to, the following: KOL Engagement * Function as a thought leader liaison to key KOLs within the migraine community and build bridge to/from customer to Axsome Therapeutics * Develop and maintain KOL engagement plans and influence maps for thought leaders * Engage with KOLs at local, regional, and national congresses and advocacy events to discuss brand, disease state and commercial strategy as well as facilitate engagements and opportunities for executive leadership in support of marketing initiatives * Gather insights from key thought leaders to inform brand strategy and support development of content, tactics, and resources, when appropriate Brand Strategy * Support cross-functional teams to gather key customer insights and input on the marketplace by garnering insights on commercial strategy, including designing local marketplace tactics, clinical messaging, access, and educational needs. * Supporting the execution of approved Commercial Advisory Boards * Assist in identification of Healthcare Professional (HCP) consultants based on profile established by the approved Consultant Engagement Project Brief * Design, Facilitate, participate in, and attend advisory boards, where appropriate * Speaker Bureau Management & Execution * Identify and develop HCP and access speakers to provide compliant, high-quality speaker programs on disease state, mechanism of disease, and product, when appropriate * Ensure appropriate and compliant execution of speaker programs * Monitor speaker performance at events and develops speakers to provide high quality promotional education through coaching as needed * Work with Marketing and contracted speakers to gain and synthesize feedback on current and future content development Requirements / Qualifications * Bachelor's degree (required); Graduate degree preferred * 8 years of pharmaceutical industry experience * 2 years of cross functional experience in at least 2 of the following areas: Field Sales, Field Sales Leadership, Product Marketing, Thought Leader Engagement, Key Account Management, Engagement with professional healthcare organizations * 50-75% travel, by air or car, is regularly required Experience, Knowledge and Skills * Demonstrated success and expertise with thought leader engagement, ad boards and speaker's bureau- strongly preferred * Marketing, sales management, and/or extensive pharmaceutical product launch experience- strongly preferred * Proven ability to successfully manage accounts in a large geographical territory including both academic and community-based HCPs * Demonstrated ability to build productive stakeholder relationships internally and externally with impactful engagement tactics * Clinical knowledge and aptitude in complex/competitive disease states, preferably in the Migraine market. * Strong intellectual curiosity with a desire to continuously learn and improve by applying new knowledge and skills on the job and innovate with market dynamics * Highly collaborative with the ability to manage multiple projects simultaneously * Self-starter with strong organizational and planning skills. Able to determine effective approaches and take the appropriate action based on the available information/resources consistent with the over-arching strategy * Effective verbal and written communication skills Salary & Benefits The anticipated salary range for this role is $160,000 - $190,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at ************** and follow us on LinkedIn and X. About This Role Axsome Therapeutics is seeking a Medical Science Liaison/Senior Medical Science Liaison to focus on developing the migraine franchise. The MSL/Senior MSL will be a key member of the Field Medical Affairs team at Axsome. This position will be the primary communicator of Axsome science and will be responsible for executing the national medical affairs plan within a specified territory. The MSL/Senior MSL will also provide support as needed for other pipeline programs. This is a field-based position covering the Northwest Region (Northern CA, Northern NV, OR, WA, ID, MT, WY, AK). Candidates must reside within the geography. Job Responsibilities and Duties include, but are not limited to, the following: * Systematically identify and develop relationships with healthcare professionals (HCPs) to raise awareness of Axsome's mission to accelerate the invention and adoption of life-changing medicines for patients living with CNS disorders, specifically in migraine * Provide fair and balanced scientific information to HCPs and to internal business partners per organizational needs * Upon request, provide formal presentations to HCPs, external stakeholders, etc. * Lead scientific discovery and communicate meaningful insights gleaned from peer-to-peer discussions with HCPs * Identify, analyze, and translate specific needs within the territory to achieve clinical and business objectives * Collaborate with internal partners, as appropriate, to advance clinical and business objectives * Build and maintain technical and clinical expertise in migraine and across other neuroscience therapeutic areas as required * Maintain knowledge base of global and regional market issues, trends, and product knowledge as it pertains to key therapeutics areas * Actively contribute to the growth and development of the National Migraine Medical Team * Execute key job functions, including documentation of field activities, submission of medical insights, completion of medical information requests, expense report submission, required trainings, and other tasks as necessary * Provide high level support for company sponsored trials and aide in navigating investigator-initiated research proposals through the review process when needed Requirements and Qualifications * Advanced degree (MD, PharmD, DO, APNP or PhD) required * Preference MSL experience is preferred * Preference for candidates with neurology, neuroscience, migraine and/or fibromyalgia experience * Candidate must reside within the geographic area * Ability to travel up to 75%, including overnight stays and weekends, as needed * Meet requirements for health industry personnel credentialing to gain access to healthcare facilities within the territory Experience and Knowledge * Ability to thrive in an entrepreneurial and autonomous environment where business needs may rapidly evolve and change * Strong attention to detail and excellent organization skills * Strong interpersonal skills and communication skills (both written and oral) * Ability to translate the data and converse appropriately with the intended audience * Comfortable multi-tasking in a fast-paced company environment and able to adjust workload based upon changing priorities * Ability to contribute to the overall field medical strategy * Problem solving oriented with the ability to identify issues and provide solutions Salary & Benefits The anticipated salary range for this role is $150,000 - $200,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at ************** and follow us on LinkedIn and X. About This Role Axsome Therapeutics is seeking a Specialty Account Manager (SAM) to execute commercial activities for assigned geographies, establish relationships with customers, and ensure successful promotion of AUVELITY for major depressive disorder in adults and potential future indications. This role is field-based and will require gaining access to customers in a clinic or hospital setting while also maximizing the ability to engage through digital channels. SAMs will be responsible for product performance at a territory level and expected to be a disease category expert and product champion. The SAM will provide account management support and exhibit business knowledge of the local landscape to assess key stakeholders plus future trends within the marketplace. Job Responsibilities and Duties include, but are not limited to, the following: * Proficient in both virtual and live customer engagements * Develop a comprehensive and effective territory business plan aimed at achieving and exceeding quarterly & annual goals established by commercial leadership * Promote within our approved labeling in a comprehensive, fair, and ethical manner that is consistent with industry specific and corporate legal and regulatory guidelines * Develop strong customer relationships by better understanding the customer's needs * Serve as a resource/consultant to customers and staff regarding payer policies and processes (i.e., eligibility and benefit verification, prior-authorization, and appeals/denials) * Maximize use of marketing resources to maintain and develop customer relationships for the purpose of growing the customers' confidence to prescribe Axsome medications for appropriate patients * Communicate territory activity in an accurate and timely manner as directed by management * Provide feedback to sales and commercial leadership, colleagues, marketing, and other internal departments about changing environment and results * Successfully complete all training classes in a timely manner * Complete administrative duties in an accurate and timely fashion * Manage efforts within assigned promotional budget * Effectively collaborate across all corporate functions * Attend medical congresses and society meetings as needed * Ensure timely access for patients through patient services and savings programs * Overnight travel as indicated by the needs of the business * Additional responsibilities as assigned Qualifications / Requirements * Bachelor's degree from an accredited college or university * Minimum of 5 years of field customer experience and/or account management. Minimum of 3 years Healthcare Professional experience with relevant CNS experience will also meet the qualifications for this role * 5 years of consistent top performance in the pharmaceutical, biotech or medical sales space * Psychiatry/CNS experience strongly preferred * Demonstrated experience delivering outstanding results * Launch experience strongly preferred * Must live in the territory's geography * Experience strategizing within cross-functional teams, utilizing differential resources to achieve business goals * Proven ability to successfully manage multiple tasks concurrently under aggressive timelines in a dynamic environment * Comfortability with uncertainty and high expectations * Patient support services experience a plus * Strong digital marketing aptitude * Strong interpersonal, presentation, and communication skills * Frequent driving, including extended periods of time behind the wheel * Prolonged sitting and standing as part of daily job functions * Ability to lift and carry up to 30lbs regularly * Overhead reaching required to close and secure liftgates or similar equipment Salary & Benefits The anticipated salary range for this role is $100,000 - $150,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.

Commercial Team Coordinator (Sales, Marketing, Commercial Operations) Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients' lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients. We are seeking a dynamic, well organized, administrative coordinator. As a member of the Allakos team you will have the opportunity to provide support to the Allakos Commercial leadership team (Sales, Marketing and Commercial Operations). The Commercial Team Coordinator will partner with both internal and external stakeholders, at varying levels across the organization providing operational and project management support to all Commercial functions, including contract requests, FMV reviews, conference logistics, budget management. This role requires highly-developed interpersonal skills, project management skills, a strong attention to detail, and a solution-oriented approach. Your Role: Administrative Support & Coordination: Assist with daily operations of the Commercial team, ensuring smooth and efficient workflow. Meeting/calendar coordination Prepare and submit expense reports for approval as appropriate Manage new hire onboarding across the Commercial team Document management using Box Manage agendas, capture and disseminate meeting notes for Commercial and other cross-functional team meetings Offsite meeting planning and logistics Coordination of travel as needed Contracts & Purchase Order Management Manage contract request process for Commercial including confidentiality agreements, vendor contracts and consulting agreements Ensure honoraria are processed according to internal processes/procedures Manage FMV monitoring process Submit requests for purchase orders Budget and invoice activity reporting to track invoices monthly/quarterly budget for projects Other responsibilities Project coordination as needed Qualifications and Expertise: Bachelor's degree in business, science, or communications is required 7+ years of experience in administrative/coordination roles At least 5 years' experience in life sciences strongly preferred Experience in a roll-your-sleeves up, startup environment with progressively increasing responsibilities Advanced knowledge of Microsoft Office (Word, PowerPoint, Excel, Outlook). Strong attention to detail Excellent written and spoken communication skills Ability to work successfully with internal senior leaders and external thought leaders and scientists Demonstrated excellent organization, project management, multi-tasking and planning skills This position is located in Redwood City, CA. and will require occasional travel The salary is competitive and commensurate with experience and qualifications. The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

Exec Director Regulatory Affairs/CMC Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases. The Executive Director, CMC Regulatory Affairs is responsible for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and marketing of drug products. They will: -Lead teams with regulatory CMC responsibility for support of development, registration and life cycle support, and CMC regulatory strategy for United States and EU. -Partner with regulatory support functions -Partner with Quality, Manufacturing, Process Development, and Supply Chain -Be the key interface between the Regulatory and the Technical Operations functions. Responsibilities: Creates and implements CMC regulatory strategies for CTA submissions and marketing applications. This role will have accountability for regulatory CMC as well as represents regulatory on key internal decision making teams. This role may oversee the work of junior CMC regulatory staff. Proactively partners with Technical Operations counterparts on processes and program prioritization. Proactively partners with the Head of Regulatory on the development of the regulatory strategy . Functions as the regulatory CMC lead , working with other Regulatory colleagues to drive regulatory strategies. Provides proactive guidance to internal groups (Quality, Manufacturing, etc) based on technical and CMC regulatory knowledge towards development of strategic and tactical plans. Identify and assess regulatory risks associated with assigned projects. Leads the development of strategic CMC plans and tactical implementation for the creation and submission of Regulatory documents, e.g., INDs, BLAs, CTAs, MAAs, and other relevant regulatory filings Serves as corporate liaison for CMC with regulatory Health Authority (HA) to develop effective professional relationships as well as a positive company image. Effectively leads key CMC focused meetings with HAs to ensure full discussion of issues and opportunities. Provides guidance to all appropriate departments to assure compliance with applicable regulations. Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel and works with regulatory policy/intel as appropriate. Makes recommendations for regulatory department operating procedures. May be responsible for creating and reviewing SOPs as needed. Leads and/or participates in regulatory and technical operation initiatives to improve processes and ways of working, keeping currently with approaches to regulatory strategy and submissions. Actively trains/mentors junior staff; provides broader guidance on regulatory interpretation to staff inside and outside Regulatory Affairs May supervise Regulatory Affairs team members. Qualifications and Expertise: BS, BSc, MS, MSc, PhD, PharmD, in science or healthcare preferred or equivalent relevant experience. 15 years of Regulatory CMC experience as well as additional experience in the biopharmaceutical industry in other areas. The regulatory experience should be broad (across the life cycle of pharmaceutical products and across main regions such as US, EU, Japan and Canada) to ensure appropriate leadership and mentoring for regulatory staff. Successfully prepared and filed a BLA, preferably for a monoclonal antibody or therapeutic protein, 5+ years of management experience preferred The salary is competitive and commensurate with experience and qualifications. Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

Senior Research Associate/Associate Scientist Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients' lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients. We are seeking to recruit a Senior Research Associate/Associate Scientist to join our research team. This is an opportunity to participate in the development of novel antibody therapeutics for the treatment of allergic, inflammatory, and proliferative diseases. The candidate will join our our pre-clinical and development group which is responsible for developing therapeutic antibodies and elucidating the biology of novel inhibitory receptors. Your Role: Design and execute in vitro/ex vivo cell and flow cytometry-based assays with primary cells from human and mouse tissues Support development of pre-clinical disease models and mechanistic efficacy studies to assess activity of monoclonal antibodies Assist with biomarker development to identify potential clinical indications Analyze data and present scientific findings at internal research meetings Qualifications and Expertise: B.S. or M.S. in Biological Sciences or related discipline with a minimum of 2 years relevant industry experience. Candidates with equivalent combination of academic achievements and industry experience will be considered In-depth knowledge of cell biology or immunology is preferred Hands-on expertise with mammalian cell culture, human and mouse primary cell culture Expertise in standard immunology assays and techniques, including cell isolation, cell culture, flow cytometry, ELISA and Luminex or MSD Excellent organization and troubleshooting skills Strong interpersonal communication skills Ability to work cooperatively in a team-based environment The salary is competitive and commensurate with experience and qualifications. The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

Director, Downstream Process Development Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients' lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients. The Director, Downstream Process Development would be key member of Biologics DS development and tech transfer team and would be responsible for all activities related to Downstream Process Development of our late-stage clinical biologics (Mab) molecule AK002 and early stage program. This position leads the Purification Group which is responsible for the process development, tech transfer, supervision of Engineering and Clinical batches, BLA enabling activities, PPQ Batches and commercial production at multiple CMO sites, process characterization and BLA authoring and review. Your Role: Provide technical and managerial leadership to the Downstream Process Development group and technology transfer of AK002 process to CMO sites. Accountable for all activities pertaining to the downstream process development lab. Supervise planning and execution of experiments. Analyze results and communicate it effectively to management. Coordinate with Upstream development, Analytical and Facilities department to successfully complete the DSP activities Provide overall strategy and experimental plan for downstream process characterization studies. Generate protocols, supervise execution, use statistical tools to analyze results and review reports for studies. Plan the downstream process development experiments for new molecules and supervise execution of the same. Supervise the Engineering and Clinical batches at the CMOs, Review and approve Batch records, Bill of Materials, Bill of Parameters, Batch records, deviations and CAPA documents for these batches Plan and supervise PPQ batches at CMOs. Review and approve protocols and reports for PPQ batches Author and review BLA submission documents Lead cross functional meetings with Quality, Regulatory, Supply Chain, Process Development, Analytical and Drug Product to build consensus on key issues and facilitate decision making to move the project forward Travel domestically and internationally up to 10% of the time Qualifications and Expertise: At least 15 years of relevant experience (12+ with MS, 10+ for PhD) successfully working in biopharmaceutical industry with proven track record of leadership and success At least 8 years managing cross functional projects and leading teams Extensive experience in Downstream process development and process characterization of biologics molecules such as Mabs and fusion proteins. Experience in technology transfer and facility fit assessments Should have worked with early and late stage and commercial biologics with experience in process development, process characterization, PPQ batches and other BLA enabling studies and CPV programs. Experience working with Contract Manufacturers is preferred. Experienced in BLA submission write ups. Experience in people and stakeholder management, conflict resolution and building consensus. Good understanding of cGMP-regulations including relevant US/EU regulatory and quality requirements, practices, and standards. Exceptional interpersonal skills to establish positive relationships with internal stakeholders, CROs/CMOs, and multi-functional/multi-cultural teams. Ability to travel at least 10% of the time. The salary is competitive and commensurate with experience and qualifications. The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or

Director/Senior Director, Lirentelimab CMC Team Leader Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory, and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients' lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients. The CMC Team Leader reports to the SVP, Technical Operations and is accountable for the AK002 (lirentelimab) CMC project activities from early stage clinical development through to commercialization, including BLA activities. This person will be a key member to the Lifecycle Product team. This role will require a candidate who is comfortable working collaboratively in a cross-functional team with technical, business, quality, regulatory representatives who also enjoys providing hands-on program leadership that will support successful execution of these critical activities. Your Role: Lead a cross-functional CMC team with functional members/sub-team leaders from Technical Operations, Regulatory and Quality, including cell culture, purification, formulations, drug product, bioanalytics, analytical development, Quality Control, device development, Quality Assurance, CMC Regulatory, Regulatory Operations, CMC Program Management, and Supply Chain / Logistics. Creates a strategic and integrated CMC development plan based on global project objectives ensuring alignment with base case plans and exploring opportunities for acceleration. Represent the CMC team and functions as core member to Executives, contributes to overall project strategy and executes the appropriate actions within CMC to achieve project goals, including development of the Quality Target Product Profile (QTPP). Acts as overall product/process expert for the project and provides technical and scientific expertise on major project topics, drives and leads technical and scientific discussion and alignment within the CMC team and in cross-functional governance and manufacturing advisory board meetings. Responsible for quality of CMC contributions to clinical and process validation work packages (DS/DP/Analytics), and CMC elements for regulatory submissions and consultations. Drive the evaluation of CMC risks and appropriately escalate to Senior Management and proactively provides mitigation plans. Partners with the CMC Lifecycle Management Team to provide technical support and expertise on the implementation and execution of Health Authority post-approval commitments. Alert decision makers and stakeholders to risks that can impact critical program timelines. In case of scientific/technical issues, coordinate corrective measures across functions in cooperation with all relevant site and department heads as needed. Responsible for implementation of CMC deliverables within budget considering external and internal costs. He/she leads and oversees planning of CMC project budget including communication and alignment with lirentelimab project team and senior management. Qualifications and Expertise: Bachelor's or master's degree in biotechnology, pharmaceutical engineering or natural sciences or related discipline with a minimum of 14 years of relevant industry experience or PhD with minimum of 10 years of relevant industry experience. Strong Biologics CMC expertise with proven experience in at least 2 scientific disciplines e.g. analytics, process dev, manufacturing, CMC regulatory, etc Experience and understanding of the current Pharmaceutical environment including the economic and regulatory challenges. Experience in BLA submission is a must. Strong leadership and team building capabilities, and able to effectively coordinate several multiple activities and stakeholders. Excellent communication, stakeholder management and networking skills. Ability to interact effectively with Senior Management Executives and external bodies (e.g., auditors, health authorities, etc.). Strong influencing and negotiation skills to build solutions and partnerships Take responsibility for decisions and be accountable for results Ability to work effectively in a fast paced, highly matrixed organization. The salary is competitive and commensurate with experience and qualifications. The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory, and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients' lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients. As a member of the Allakos team, you will be responsible for partnering with Quality, R&D and other Allakos functions to identify, design, implement and support business capabilities. You will also manage and support Computer System Validation (CSV) activities. The successful candidate must be an experienced professional with software development life cycle understanding, strong project management fundamentals, business process analysis skills, and best practice software configuration knowledge. This position will work closely with business partners/stakeholders to integrate technology and business processes into effective, efficient, and scalable solutions. The success of the position will be measured on IT project management delivery, fit of technology solutions to business capability needs, business partners/stakeholder feedback and IT support metrics. This position is based in Redwood City, CA and reports to the Senior Director - IT Business Systems. Your Role: Assure that GxP compliance requirements are properly assessed, and that appropriate Computer Systems Validation is implemented for both new solutions and improvements to existing systems Partner with Quality to establish and maintain CSV and GxP compliance Partner with functional business leaders to understand their technology needs and ensure technology investments are scoped and prioritized properly to maximize the company's technology investments. Review system requirements and prepares recommendations anticipating future application needs. Lead new system selection processes including requirement gathering, RFP development, and software vendor selection. Responsible for providing day-to-day support, system administration, availability and performance monitoring, and continuous improvement activities for systems in portfolio; in conjunction, develops standard operating procedures (SOP), trains personnel on use and manages upgrade. Establish and maintain positive relationships with business partners including co-workers and management. Execute agreed upon service levels (i.e., project schedules, system availability, & service quality). Develop and maintain IT Roadmaps in association with Business Partners/Stakeholders Conduct ongoing research into industry and technology trends. Keep stakeholders sufficiently informed on progress with initiatives or deliverables Qualifications and Expertise: Bachelor's degree in the field of computer science or information systems or related field required, or equivalent combination of education and experience required. 5+ years working on IT implementation/management Experience in Life Sciences (Biotech, Pharmaceuticals, Medical Device) industry including implementation of solutions with a focus on GxP compliance Experience with Veeva Vault (Quality Docs, QMS) preferred. Experience with Computer System Validation. Strong project management skills and execution record Detail-oriented, well organized, and able to assume responsibility for specific project deliverables with limited supervision. Ability to deliver results in a fast-paced, deadline-driven environment that requires the oversight of multiple tasks simultaneously. Ability to provide Level 1 support for the applications in the portfolio Ability to effectively manage service providers/vendors supporting business systems Strong interpersonal skills and a demonstrated ability to work effectively both independently as well as in a team environment. Good communication skills and an ability to interact with staff of all levels of the company. Detail-oriented; with strong analytical, organization, and problem-solving skills. Must have the ability to troubleshoot, research, and solve technically challenging problems involving integrated systems. Strong customer service orientation and a high-level understanding of business processes related to pharmaceutical corporate activities. The salary is competitive and commensurate with experience and qualifications. The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City. About This Role Axsome Therapeutics is currently searching for a Regional Business Director (RBD) to lead commercial activities for an assigned geography, establish a team of Account Managers, execute marketing strategies, and ensure a successful launch. The RBD will be primarily responsible for the supervision and leadership of an industry shaping, uniquely structured salesforce leveraging the use of a highly sophisticated digital infrastructure. All sales representatives will be aligned to geographical boundaries. The RBD is responsible for sales performance at a Region level and is expected to be a product champion and exhibit the business knowledge of the local landscape to assess key stakeholders plus future trends within the marketplace. This is a cross-functional front-line leader role that will focus on Sunosi (solriamfetol), which is indicated to improve wakefulness in adults with excessive daytime sleepiness due to obstructive sleep apnea or narcolepsy. The position is field-based and will require travel as needed to develop internal and external relationships. Job Responsibilities and Duties include, but are not limited to, the following: * Responsible for supervising operations of the Region which includes: driving results, hiring and coaching, account manager development, performance management, and the assignment of key "priority" accounts within the medical community * Develop and implement strategic plans for the Region including the right balance of live/virtual interactions and the prioritization of efforts by the team * Plan, organize and drive performance to achieve the business potential of the region through coaching and influence of direct reports * Establish and maintain effective communication among all members of the Region across cross-channel stakeholders in the Accounts and Market Access team * Maintain required technical expertise in order to respond accurately to all questions regarding products, marketing, policies, and business-related issues from customers and account managers * Work with direct reports to understand and consistently execute established expectations. * Consistently exemplify the ability to help a SAM improve on their selling skills, product knowledge and capabilities needed for success through coaching and counsel. Lead by example through coaching direct reports both in live and virtual engagements. * Effectively plan and conduct plan of action and other meetings with members of the Region and Market Access teams * Develop and implement Region business plan, manage Region budget and overall responsibility for P&L at Region level in alignment with Regional and National expectations * Have a complete understanding of all relevant compliance laws, policies and processes and ensure actions of self and team are fully compliant * Overnight travel as indicated by the needs of the business * Additional responsibilities as assigned Qualifications / Requirements * BA or BS required. Advanced degree preferred * 5 years or more of field leadership experience and/or payer account management and/or demonstrated sales success with increasing responsibility and organizational leadership * Previous pharmaceutical, biotech, or medical marketing/sales experience preferred with at least three to five years spent in a position with demonstrated 1st line leadership groups * Proven performance history in the ability to lead others to success through your coaching influence * Demonstrated experience delivering outstanding results and developing others to their potential * Proven track record in attracting and retaining top talent * Current or recent sleep/CNS experience strongly preferred * Successful launch experience strongly preferred * Experience to strategize within teams using differential resources to reach business goals * Proven ability to run multiple tasks concurrently under aggressive timelines in a dynamic environment * Must live within the territory's geography * Comfortable with uncertainty and high expectations * Patient support services experience a plus * Strong digital marketing aptitude * Strong interpersonal and presentation skills Salary & Benefits The anticipated salary range for this role is $170,000 - $210,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.

Associate Director, Downstream Process Development Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients' lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients. As a member of the Allakos team you will have the opportunity to be a key member of the Biologics DS development and Tech Transfer team and responsible for activities related to Downstream Process Development of our late-stage clinical biologic (Mab) molecule AK002 and other early-stage programs. This position will be responsible for the Process Development, Tech Transfer, and oversite of Engineering/Clinical batches at contract manufacturing site/s. Additionally, there will be a strong focus on BLA-enabling activities including process characterization, PPQ Batches and BLA authoring and review. Your Role: Provide technical leadership to the Downstream Process Development group and technology transfer of AK002 process to CMO sites. Accountable for activities pertaining to the downstream process development lab. Supervise planning and execution of experiments. Analyze results and communicate them effectively to management. Coordinate with Upstream Development, Analytical, and Facilities departments to successfully complete the DSP activities. Provide input for the strategy and experimental plan for downstream process characterization studies. Generate protocols, supervise execution, use statistical tools to analyze results, and review reports for studies. Assist in the planning of downstream process development experiments for new molecules and supervise execution of the same. Supervise the Engineering and Clinical batches at CMOs, review and approve Deviations and CAPA documents for these batches. Plan and supervise PPQ batches at CMOs. Review and approve protocols and reports for PPQ batches. Author BLA submission documents. Travel domestically and internationally up to 10% of the time. What We Value: At least 12 years of relevant experience (10+ with M.S., 8+ for Ph.D.) successfully working in the biopharmaceutical industry with proven track record of leadership and success. At least 5 years managing cross functional projects and leading teams. Extensive experience in Downstream Process Development and process characterization of biologics, such as Mabs and fusion proteins. Strong background in statistical design of experiments (DoE) and associated analysis Experience in technology transfer and facility fit assessments. Should have worked with late and commercial stage biologics, with experience in process development, process characterization, PPQ batches, and other BLA enabling studies and CPV programs. Experience working with Contract Manufacturers is preferred. Experienced in BLA submission write ups. Experienced in people and stakeholder management, conflict resolution, and building consensus. Good understanding of cGMP-regulations including relevant US/EU regulatory and quality requirements, practices, and standards. Exceptional interpersonal skills to establish positive relationships with internal stakeholders, CROs/CMOs, and multi-functional/multi-cultural teams. Ability to travel at least 10% of the time. The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership . Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

Senior/Executive Medical Director, Medical Affairs and Clinical Development- Allergy/Gastroenterology Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients' lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients. The Senior/Executive Medical Director will provide clinical and scientific leadership for medical affairs and clinical development activities in the areas of Allergy and Gastroenterology. The position will report directly to the Vice President, Medical Affairs and Clinical Development and play a critical role in designing, implementing, and monitoring clinical studies, as well as contributing to data analysis and creation of study reports for our lead compound, Lirentelimab. In addition, the Senior/Executive Medical Director will play a key role in generating and communicating medical evidence with external stakeholders and will be expected to be a team player with well-developed skills for gaining the cooperation of others and ensuring effective communication among team members. This position will also represent the Medical Affairs and Clinical Development function within cross-functional teams at Allakos and in external customer-facing engagements. Your Role: Provide leadership of the strategy and development of Lirentelimab's annual Medical Plans and ensure hands-on implementation of key activities Have a strong outward-facing presence while building relationships with Allergists, Gastroenterologists, Pathologists and other key stakeholders Provide the medical perspective for the Lirentelimab development program to executives, peers and other members of Medical Affairs team Develop and review content for medical and scientific information exchange as well as for educational activities Identify opportunities for research collaborations and partnerships with Allergy, Gastroenterology and Pathology experts, medical societies, patient advocacy groups and other stakeholders Develop and ensure the clinical and medical accuracy of training materials Provide input on manuscripts and expert review of publications and abstracts Conduct medical data analyses and interpretation Contribute to the development of clinical trial protocols and study reports, medical monitoring plans, safety data reviews, and regulatory licensing applications Ensure safety oversight of Allakos clinical trials including functioning as a medical monitor Qualifications and Expertise: Advanced clinical degree required, MD or DO, with specialty certification (or relevant experience) in Gastroenterology, Pathology, Allergy and/or Immunology (current or previous U.S. medical licensure and clinical experience strongly preferred) Minimum 5 years of relevant clinical/medical pharmaceutical/biotechnology industry experience Experience with regulatory agency interactions and preparation of regulatory submissions documents including license applications preferred Flexibility in prioritizing work and ability to thrive in a rapidly changing environment Demonstrated ability to establish priorities, manage shifting priorities, and handle numerous time-sensitive projects with multiple deadlines Demonstrated creativity, problem solving, critical analysis, initiative, judgment and, decision-making skills Strong ability to work within a team environment and professionally represent Allakos to various external stakeholders Excellent interpersonal, written and oral communication skills Strong relevant subject matter knowledge and working knowledge of biostatistics would be an asset This position is located in Redwood City, CA and requires up to 40% time traveling. The salary is competitive and commensurate with experience and qualifications. The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

Senior Research Associate/Associate Scientist, Protein Biochemistry Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients' lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients. We are seeking a highly motivated Senior Research Associate/Associate Scientist with a strong background in protein biochemistry to join our R&D team. The selected candidate will be responsible for generating reagents for the department to support our lead and preclinical antibody programs. This position will provide the candidate an opportunity to perform a wide range of activities and to expand/learn new techniques. Your Role: Perform protein expression, purification, and modification of proteins and antibodies Characterize purified proteins using established protocols Assist in developing new assays to characterize purified proteins Assist in biochemically screening monoclonal antibodies for new targets Assist in managing monoclonal antibody campaigns for new therapeutic targets Produce reports and protocols Present regular research updates to project teams and R&D management Qualifications and Expertise: B.S. or M.S. in Biological Sciences or related discipline with a minimum of 3-4 years relevant industry experience In-depth knowledge of protein biochemistry Proficient use of AKTA systems for protein purification Protein Characterization techniques such as SDS-PAGE, UV spectroscopy, and HPLC Tissue culture experience a plus but not required Excellent organization and troubleshooting skills Strong interpersonal communication skills Ability to work cooperatively in a team-based environment Flexibility in prioritizing work and ability to multitask and successfully interact to meat deadlines This position is located in Redwood City, CA. The salary is competitive and commensurate with experience and qualifications. The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

Associate Director / Senior Manager, Clinical Development Program Manager Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients' lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients. The Associate Director or Senior Program Manager, as a core member of the Lirentelimab Clinical Development team, drives development programs in order to maximize program value and patient benefit. The role is considered the Chief of Staff and a strategic thought partner to the R&D Senior Leadership. The role accelerates informed decision-making, leads effective ways of working, and catalyzes change. Position reports to the Senior Vice President of Strategy & Operations. Your Role: Contribute to shaping the program strategy and enable its execution by translating the strategy into tangible outcomes via effective project planning, team management including human resource allocation, and process management using agile methods and tools. Drive the identification of opportunities to accelerate program execution including leading working groups and advising and coaching working group leads. Partner with senior stakeholders to make informed decisions more quickly. Facilitate Clinical Development Team meetings in alignment with CMO. Drive the development and execution of the team priorities. Drive communication within the program to ensure awareness and alignment of project decisions, priorities and key milestone updates Accountable to maintain key milestones and to manage the project plans of the program. Champion team dynamics and lead new ways of working with the aim to build a high-performing team in collaboration with the team performance coach. Lead and/or contribute to functional initiatives or represent the department effectively on cross-functional teams to contribute to the broader organization. Assist with additional project management responsibilities to support the broader Product Team Meeting and Launch Readiness Review as needed. Qualifications and Expertise: Successful candidates will have a minimum of 7 years of relevant drug development experience in the pharma/biotech industry, including a minimum of 5 years supporting cross-functional teams in a scientific and/or commercial environment required. Bachelor's degree required; advanced degree preferred. Strategic and analytical thinking skills to assimilate complex information to inform decisions. Strategic leadership and influence to be effective in a highly matrixed organization with geographically dispersed teams. Operate effectively in situations of ambiguity and guide teams through challenges, simplifying/distilling complex issues and influencing change in a skillful and mindful way. Demonstrated contributions to functional and/or cross-functional initiatives. Anticipate the needs of the program/business and proactively drive teams with portfolio context in mind. Effective use of interpersonal skills and influence to drive optimal team performance. Display of leadership competency, executive presence, and emotional intelligence. Excellent written and verbal English communication. Project management certification and significant relevant exposure is preferred. The salary is competitive and commensurate with experience and qualifications. The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

Sr. Director, Analytical Development and Quality Control Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory, and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients' lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients. As a member of the Allakos team you will have the opportunity to provide direction and oversight of technical activities associated with methods development, qualification, and validation in support of development of Allakos' biologics therapeutics targeting eosinophil and mast cell-driven diseases. You will also oversee the outsourced DS and DP release and stability testing. The position reports to the SVP of Technical Operations and is based in Redwood City, CA office. Your Role: Provide technical leadership and guidance across CMC development disciplines to all outsourced analytical methods and testing activities by providing clear objectives for multiple CDMO partners, assess all experimental plans and results, and coordinate future work to achieve desired development and manufacturing expectations Scope of technical responsibilities include bioanalytical and analytical methods development and transfer, qualification and validation, and stability studies Build collaborative relationships across functional areas to translate research and clinical program objectives into aligned, clear, and fit-for-purpose CMC objectives and milestones As an experienced CMC leader, provide options and contingencies to overcome technical challenges, timeline limitations, or changes to program goals Develop strong relationships with external CDMO partners to establish and manage appropriate scopes of work, and to ensure all activities are within program expectations Provide succinct and pertinent communication of program CMC status, priorities and pending activities, verbal and written, across company functional areas and to senior leadership Support, in collaboration with Quality and Regulatory, selection of strategic CDMO, manufacturing, analytical, and packaging partners, initially focused on early-stage programs. Negotiate, obtain, and review for accuracy legal and corporate approval for service agreements and related statements of work for development activities with external partners In collaboration with Quality Assurance, develop SOPs and guidelines related to the production, planning, disposition and management, materials handling, and documentation; Ensure these Quality standards are followed at CDMOs Work with Regulatory, QA and Senior Management to ensure that all company policies are followed, and all external manufacturing activities comply with relevant regulations Support creation and/or review of CMC sections of regulatory submissions (i.e. IMPD/INDs/NDA), and responses to regulatory agency correspondence (i.e., FDA, EMA, etc.). Qualifications and Expertise: 15 + years of pharmaceutical development experience with at least 5 years of CMC team leadership in the biotechnology or pharmaceutical industry. Advanced Degree in Analytical Chemistry, or Pharmaceutical Sciences Successful track record in leading CMC activities through transition from research to clinical studies, Ph1 to registration Technical expertise in analytical process and product characterization and stability of biologics Thorough understanding of ICH, FDA, and EMA guidance and GMP requirements governing product/process development and manufacture, and stability Proficiency in analysis of scientific data and results with ability to review scientific documents including reports, publications, and regulatory submissions Proven leadership and cross-functional management of multiple CMC programs. Track record of successfully driving and managing programs, overcoming challenges and risks Demonstrated ability to work effectively in a fast-paced, team-oriented environment Excellent communication skills (interpersonal, written and verbal), and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators) Must be well organized, proactive, and detail-oriented The salary is competitive and commensurate with experience and qualifications. The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

Associate Director Device Development & Manufacturing Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients' lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients. As a member of the Allakos team you will have the opportunity to form and lead our device/combination product program. You will be a strategic player within Technical Operations, by serving as a team leader for device development and device assembly/manufacturing. This is a leadership role to derive and execute a comprehensive drug/device combination product development and manufacturing development program at Allakos. This is an influential role in the organization that will interact extensively with Program Team members and Allakos leadership to deliver results. To be successful in this role, the ideal candidate must have parenteral drug delivery device development expertise including autoinjector development and design transfer experience, regulatory and quality awareness, strategic thinking, strong business acumen, excellent leadership and communication skills. Your Role: Lead cross-functional team supporting the development and operationalization of Allakos drug delivery device programs. With responsibility for design controls, relevant CMC source documents necessary for regulatory filings or health authority interactions. Oversee product development, design transfer to manufacturing at CMOs, device testing, and project delivery. Lead drug/device combination product development through registration, tech transfer, process validation, and launch. Oversee development of design control documents, d-FMEA, hazard analysis, test methods, and validation studies. This role will represent the department by defining and communicating strategic operational direction, serving as a visible program champion and a focal point for critical program information, compiling the technical development plan, and recognizing and solving critical issues with the CMC Team and the department. This leader is accountable to deliver regulatory documents for global submissions. Effectively manage device development team meetings including the scheduling of meetings, the preparation of agendas, the development of meeting minutes, and the follow up on action items. Manage and drive the various parts of the timeline and escalate issues as required. Develop critical path analyses to identify potential ways to accelerate timelines and mitigate risks. Promote a culture of collaboration, cooperation, cross functional inclusion, execution excellence, effective communication and cross-functional problem-solving to become a high-performing team. Qualifications and Expertise: Experience leading device development programs and cross functional development. Advanced knowledge of FDA, EMA and ICH, ISO regulations, and industry standards for drug/device combination products. Demonstrated technical proficiency, independent thought, and ability to effectively collaborate with others. Experience working with all levels of management and consulting with key business stakeholders. An ability to communicate with leadership for greater outcomes. Strong team player that is solution oriented. Attention to detail and the ability to work as a leader, individually, within a multi-disciplinary team in a matrix environment, as well as with external partners. The Allakos Values are: Selfless, Drive, Clarity, Thoughtful, Fun, and Leadership . The salary is competitive and commensurate with experience and qualifications. Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at ************** and follow us on LinkedIn and X. About This Role Axsome Therapeutics is seeking a Specialty Account Manager (SAM) to execute commercial activities for assigned geographies, establish relationships with customers, and ensure successful promotion of AUVELITY for major depressive disorder in adults and potential future indications. This role is field-based and will require gaining access to customers in a clinic or hospital setting while also maximizing the ability to engage through digital channels. SAMs will be responsible for product performance at a territory level and expected to be a disease category expert and product champion. The SAM will provide account management support and exhibit business knowledge of the local landscape to assess key stakeholders plus future trends within the marketplace. Job Responsibilities and Duties include, but are not limited to, the following: * Proficient in both virtual and live customer engagements * Develop a comprehensive and effective territory business plan aimed at achieving and exceeding quarterly & annual goals established by commercial leadership * Promote within our approved labeling in a comprehensive, fair, and ethical manner that is consistent with industry specific and corporate legal and regulatory guidelines * Develop strong customer relationships by better understanding the customer's needs * Serve as a resource/consultant to customers and staff regarding payer policies and processes (i.e., eligibility and benefit verification, prior-authorization, and appeals/denials) * Maximize use of marketing resources to maintain and develop customer relationships for the purpose of growing the customers' confidence to prescribe Axsome medications for appropriate patients * Communicate territory activity in an accurate and timely manner as directed by management * Provide feedback to sales and commercial leadership, colleagues, marketing, and other internal departments about changing environment and results * Successfully complete all training classes in a timely manner * Complete administrative duties in an accurate and timely fashion * Manage efforts within assigned promotional budget * Effectively collaborate across all corporate functions * Attend medical congresses and society meetings as needed * Ensure timely access for patients through patient services and savings programs * Overnight travel as indicated by the needs of the business * Additional responsibilities as assigned Qualifications / Requirements * Bachelor's degree from an accredited college or university * Minimum of 5 years of field customer experience and/or account management. Minimum of 3 years Healthcare Professional experience with relevant CNS experience will also meet the qualifications for this role * 5 years of consistent top performance in the pharmaceutical, biotech or medical sales space * Psychiatry/CNS experience strongly preferred * Demonstrated experience delivering outstanding results * Launch experience strongly preferred * Must live in the territory's geography * Experience strategizing within cross-functional teams, utilizing differential resources to achieve business goals * Proven ability to successfully manage multiple tasks concurrently under aggressive timelines in a dynamic environment * Comfortability with uncertainty and high expectations * Patient support services experience a plus * Strong digital marketing aptitude * Strong interpersonal, presentation, and communication skills * Frequent driving, including extended periods of time behind the wheel * Prolonged sitting and standing as part of daily job functions * Ability to lift and carry up to 30lbs regularly * Overhead reaching required to close and secure liftgates or similar equipment Salary & Benefits The anticipated salary range for this role is $100,000 - $150,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City. About This Role Axsome Therapeutics is currently searching for a Regional Business Director (RBD) to lead commercial activities for an assigned geography, establish a team of Account Managers, execute marketing strategies, and ensure a successful launch. The RBD will be primarily responsible for the supervision and leadership of an industry shaping, uniquely structured salesforce leveraging the use of a highly sophisticated digital infrastructure. All sales representatives will be aligned to geographical boundaries. The RBD is responsible for sales performance at a Region level and is expected to be a product champion and exhibit the business knowledge of the local landscape to assess key stakeholders plus future trends within the marketplace. This is a cross-functional front-line leader role that will focus on our growth brand for the treatment of Major Depressive Disorder in Adults, Auvelity. The position is field-based and will require travel as needed to develop internal and external relationships. Job Responsibilities and Duties include, but are not limited to, the following: * Responsible for supervising operations of the Region which includes: driving results, hiring and coaching, account manager development, performance management, and the assignment of key "priority" accounts within the medical community * Develop and implement strategic plans for the Region including the right balance of live/virtual interactions and the prioritization of efforts by the team * Plan, organize and drive performance to achieve the business potential of the region through coaching and influence of direct reports * Establish and maintain effective communication among all members of the Region across cross-channel stakeholders in the Accounts and Market Access team * Maintain required technical expertise in order to respond accurately to all questions regarding products, marketing, policies, and business-related issues from customers and account managers * Work with direct reports to understand and consistently execute established expectations. * Consistently exemplify the ability to help a SAM improve on their selling skills, product knowledge and capabilities needed for success through coaching and counsel. Lead by example through coaching direct reports both in live and virtual engagements. * Effectively plan and conduct plan of action and other meetings with members of the Region and Market Access teams * Develop and implement Region business plan, manage Region budget and overall responsibility for P&L at Region level in alignment with Regional and National expectations * Have a complete understanding of all relevant compliance laws, policies and processes and ensure actions of self and team are fully compliant * Overnight travel as indicated by the needs of the business * Additional responsibilities as assigned Qualifications / Requirements * BA or BS required. Advanced degree preferred * 5 years or more of field leadership experience and/or payer account management and/or demonstrated sales success with increasing responsibility and organizational leadership * Previous pharmaceutical, biotech, or medical marketing/sales experience preferred with at least three to five years spent in a position with demonstrated 1st line leadership groups * Proven performance history in the ability to lead others to success through your coaching influence * Demonstrated experience delivering outstanding results and developing others to their potential * Proven track record in attracting and retaining top talent * Current or recent Psychiatry disease experience strongly preferred * Successful launch experience strongly preferred * Experience to strategize within teams using differential resources to reach business goals * Proven ability to run multiple tasks concurrently under aggressive timelines in a dynamic environment * Must live within the territory's geography * Comfortable with uncertainty and high expectations * Patient support services experience a plus * Strong digital marketing aptitude * Strong interpersonal and presentation skills Salary & Benefits The anticipated salary range for this role is $170,000 - $205,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.