Careers

The Executive Director, Early Clinical Development will lead the development of early assets. The successful candidate will join our team, working directly with Chief Medical Officer (CMO). This is an opportunity for a well-trained clinician with strong leadership skills who is driven by science and the desire to develop innovative therapies for cancer patients. The successful candidate will have a mastery of the drug development process in early phase clinical trials, protocol writing, study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully. This is a remote-based position.

• Serve as Medical Monitor for Early Clinical Development assets, responsible for the safety monitoring of clinical trials, and as the medical expert for Phase I/II studies, managing the process from protocol development through individual study reports and integrated regulatory documentation; provide oversight and guidance to clinical team activities
• Monitor study progress ensuring proper study conduct and adherence to the protocol, lead data review, evaluation, and analyses with support from Data Management and Stats & Programming team
• Address patient eligibility and treatment questions in cooperation with CRO or directly with study investigators
• Review safety data for routine medical data review, trend review, and safety signals from ongoing trials
• Assist as needed with the clinical development group in a variety of clinical deliverables, i.e., coding and data cleaning in collaboration with clinical operations and data management, collecting external data and competitive intelligence
• Author clinical sections in regulatory documents not limited to IND submission and annual updates, protocols, IB, briefing documents, and other study-related documents such as patient informed consent documents; author manuscripts, publications, or other documents intended for external audiences
• Serve as an internal resource for functions requiring clinical input on select assets, including primary point of contact for clinical trial teams at study sites for clinical issues, regulatory and safety, and other functions
• Review potential in-licensing candidates and present recommendations to Senior Management groups
• Contribute to the scientific, clinical, and commercial development of current and future product candidates; contribute to Strategic or Clinical Advisory Boards and support Medical Affairs and Business Development as needed

• MD (or equivalent) in Oncology, US fellowship, and board certification preferred
• Training in basis or translational science training is preferred
• A minimum of 10 years of experience with experience in small and large pharma may contain academic and clinical experience
• Experience with clinical trial design, conduct, and medical monitoring
• Very familiar with IND process and submissions; experience and/or exposure with (s)NDA and MAA submissions and processes
• Knowledgeable and current in GCP guidelines
• Extensive knowledge of Hematology, Oncology and Immune-oncology clinical drug development, including FDA regulations, statistics, safety, etc.
• Excellent written and verbal communication skills
• Willing and able to travel as needed

Please apply to this position at the following link: Elevar Therapeutics, Inc – Executive Director, Early Clinical Development – 22-150 (paylocity.com)

The Senior Medical Director, Clinical Development will support Elevar assets by successful execution of clinical development programs and deliverables in partnership across the organization including cross-functional teams, external vendors, academicians, and collaboration partners and play a critical role in partnering with the Chief Medical Officer (CMO) in defining the clinical strategy for the company. The successful candidate will provide medical and clinical program input on strategy, design, execution, and interpretation of data from late-stage clinical solid tumor programs. The successful candidate will also provide research into strategy and competitive landscape for various assets in the oncology-hematology-immumo/oncology space.

This individual will be responsible for ensuring that all studies under her/his purview are conducted with the highest level of ethical and safety standards and follow GCP and all regulatory policies. Duties include primary interactions with investigators, CROs, other vendors, and development partners, functioning as the medical representative on the integrated project team, and providing medical consultation as needed across the Elevar portfolio of products and studies.

A genuine interest and understanding of the science, desire to work in a highly collaborative organization and deep passion for making a difference in patients’ lives are essential. This is a remote-based position.

• Medical monitoring of one or more clinical trials; review and interpret clinical trial data; medical review of eligibility data
• Author and review of key documents including but not limited to protocol synopsis, protocols, amendments, medical development plan, IB, ICFs, CSRs, CRFs, abstracts, posters, manuscripts, clinical section of INDs, NDAs, MAAs, annual reports, DSURs, clinical narratives, Regulatory Packages, Briefing Documents, Clinical Development Plans, Data queries, and others
• Provide oversight and medical accountability for the company’s clinical trials
• Evaluate scientific information and new ideas to assist in identifying new research opportunities
• Secure, analyze, and report on competitive intelligence related to successful conduct/execution of studies sponsored by other organizations and new data that may impact Elevar programs
• Responsible for resourcing assigned clinical development programs within functional area;
  contribute to CDP for one or more assets
• Represent clinical development to KOLs, investigators, and regulatory agencies
• Present findings internally and externally (e.g., investigator meetings, regulatory agency meetings) acting as a spokesperson for Elevar; contribute to determining global strategy for development of oncology assets
• Work cross-functionally with clinical operations, biometrics and data management, drug safety, regulatory, clinical pharmacology, medical affairs, etc.; successfully interface with development partners
• Prepare manuscripts, abstracts, and presentations for scientific meetings

• MD (or equivalent) required with 5+ years’ experience in Oncology clinical development, with experience in small and large pharma. Candidates with exceptional experience in other therapeutic areas will be considered if they demonstrate clear potential to apply their existing skills to Oncology.
• Training in Oncology required; US fellowship and board certification preferred
• Those without an MD or DO, with a Ph.D. or PharmD, may be considered for a Clinical Science title
• Direct experience in co-authoring IND, NDA, (s)NDA, and/or MAA
• Global clinical trial experience, including Phases 1 through 3 studies
• Extensive knowledge of oncology clinical drug development, including FDA regulations, GCP, statistics, safety, HIPPA rules, etc.
• Experience in working with small molecule targeted agents; experience with VEGFR inhibitors a plus
• Excellent written and verbal communication skills
• Willing and able to travel, as needed

Please apply to this position at the following link: Elevar Therapeutics, Inc – Senior Medical Director, Clinical Development – 22-151 (paylocity.com)

The Senior Director, Clinical Pharmacology will co-function as a subject matter expert supporting all nonclinical, DMPK and clinical pharmacology development for small molecule oral drugs in development in the Oncology therapeutic area. The Senior Director, Clinical Pharmacology will co-determine and execute on strategy for DMPK and clinical pharmacology studies, including an assessment of required studies, gap analysis, vendor selection and oversight, and data interpretation. This individual will develop strategy and work with vendors on clinical pharmacology studies including BA/BE, DDI, popPK, PBPK and E-R modeling. This role will include the co-authoring of nonclinical, PK and clinical pharmacology modules of NDA, MAA, etc. This is a remote-based position.

• Works independently and with project teams to develop and execute clinical pharmacology development programs, PK/PD modeling and/or bioanalysis of PK samples
• Analyze, summarize and interpret nonclinical and clinical pharmacology data and/or integrate study results into the ongoing clinical development strategy
• Co-manage external vendors/CROs involved in the clinical studies
• Aid in the design plans to support regulatory filings such as eCTD/NDA etc.
• Participate in authoring and review of PK and clinical pharmacology sections of regulatory documents (e.g., protocols, SAPs, CSRs, IBs) and responses to regulatory agencies

• PhD in pharmacokinetics, clinical pharmacology, pharmacometrics, drug metabolism, pharmacology or related discipline
• 15 years overall experience including 5 to 7+ years of research and development experience with at least 5 years within the pharmaceutical industry, at least some of which has been in start-up environment, with demonstrated experience in advancing clinical pharmacology studies through clinical development
• Must be hands-on as well as strategic
• Proven solid experience with managing clinical pharmacology vendors/CROs
• Hands-on experience with population PK, PBPK and E-R modeling
• Hands-on experience in co-directing strategy and authoring nonclinical, PK and clinical pharmacology modules of NDA and MAA
• Oncology small molecule experience preferred
• Excellent oral and written communication skills
• Strong leadership skills preferred

Please apply to this position at the following link: Elevar Therapeutics, Inc – Senior Director, Clinical Pharmacology – 22-156 (paylocity.com)

The Director, CMC Drug Substance serves as the responsible leader with oversight of CMC Drug Substance in support of progressing Elevar’s development pipeline and ensuring sustained product supply. He/She will provide strategic guidance on short- and long-term planning as well as technical insight in the implementation, optimization, and establishing robustness of the manufacture of drug substance. The role will involve significant collaboration within the CMC group as well as cross functionally with regulatory, quality, and external partners. This is a remote-based position.

• Directs the CMC drug substance development and manufacturing activities within Elevar’s portfolio by providing scientific and technical leadership including oversight of multiple projects at various stages of the drug development life cycle from late phase clinical studies, through filing/launch and sustained supply
• Leads or contributes to the strategy, planning, execution, and progress reporting for development projects as well commercial products
• Identifies, evaluates, selects, and develops relationships and actively manages external partners (CROs, CMOs, RM suppliers, consultants, etc.). This includes writing, reviewing, and managing requests for proposals, statements of work, contracts, budgets, and timelines
• Ensures processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines, and practices
• Develops and provides high level guidance to senior management on CMC requirements and generates project and resource plans for company drug substance development
• Preparation of necessary CMC documents suitable for regulatory filings as needed
• Efficiently supports cross functional project teams. Coordinates drug substance activities with analytical and drug product development teams within CMC. Understands and supports the needs and requirements from other functional groups including toxicology, pharmacokinetics, and regulatory. Provides updates to project and management teams

• Ph.D. in organic chemistry (preferred) or chemical engineer with at least 7 or more years of related technical experience in the pharmaceutical/biotech industry
• In depth knowledge and experience in synthetic route development, process optimization, large-scale manufacturing of drug substance and technical transfer to external partners
• Prior experience selecting and working with domestic and international CMOs and consultants including awareness of best industry practice and emergence of enabling technology
• Familiarity with analytical techniques and methods used to characterize small molecule APIs
• A broad understanding of cGLP/cGMP requirements, compendia testing, ICH, FDA, and EMA guidelines with respect to pharmaceutical product development and manufacture
• Author appropriate Quality sections for regulatory submissions (IND, IMPD, and/or NDA)
• Experienced in developing a robust control strategy including defining process risks, identifying critical process parameters (CPP) and establishing proven acceptable ranges (PAR)
• Excellent interpersonal and communication skills (written and oral), including the ability to effectively and accurately present data to peers, management, and external partners
• Excellent ability to work both independently and in a matrix team environment, in a goal and team-oriented setting and handle competing priorities
• Strong ethical standards, with the ability to speak up, identifying critical risks and gaps while providing appropriate mitigations/solutions
• Provide a positive approach to Elevar’s workspace, while fostering an inclusive and collaborative environment

Elevar’s policy is to provide equal employment opportunities to all applicants and employees without regards to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.

Please apply to this position at the following link: Elevar Therapeutics, Inc – Director, CMC Drug Substance – 22-161 (paylocity.com)