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CAREER OPPORTUNITIES

Directs the staff and programs of the organization’s pre-clinical development programs leading to successful Investigational New Drug (IND) filing(s). Works closely with CRO staff, department directors, CRO networks, and physicians to ensure that the highest standards of quality and service are instituted and maintained through the pre-clinical development process. Part of Executive Team and will interact directly with Management and the Board of Directors. Will lead discussions with regulatory agencies in order to progress approval pathways. Manages a departmental function within a broader corporate function. Develops major goals to support broad functional objectives. Approves policies developed within various sub-functions and departments. Comprehensive knowledge of the overall pre-clinical development process leading to successful IND filings and NDA acceptance.

  • CSO or similar experience for 10+ years.
  • Comprehensive Drug Discovery program experience.
  • Experience working with the FDA related to IND filing(s).
  • Rare, orphan, and cannabinoid experience is preferential.
  • Experience working in small, start-up life science organizations.
  • Excellent communication, both verbal and written, with a keen eye for detail is required.
  • Flexibility, adaptability, and excellent judgment is required.
  • This position is located in Doylestown, PA – remote is OK.

A privately held, clinical stage biopharma is looking for a Chief Executive Officer (CEO). The CEO is responsible for providing strategic leadership for the company by working with the Board and other management to establish strategies, plans, and policies. The CEO will make a significant contribution to business development, the monetization of existing IP and development of new IP, setting the corporate culture, and the overall growth of the organization.

  • An undergraduate degree in the Sciences or Business is required, with an advanced degree (MBA, MD, PhD, etc.) highly preferred.
  • The ideal candidate will have 20+ years pharma experience – including executive leadership – within both the corporate and “start-up” sectors. Public company experience is preferred.
  • A proven track record of working effectively with his/her Board of Directors and being a highly disciplined communicator with all stakeholders including customers, strategic partners, and employees.
  • Experience with corporate governance.
  • Ability to build consensus and relationships among executives, partners, and the workforce. Encourage employee engagement.
  • Have an extensive network, including C-level contacts, to forge new Business Development relationships in existing and new markets.
  • A high level of personal skills is required to make formal, persuasive presentations to groups and to deal effectively with the Board, investors, and internal personnel.
  • Proven ability to successfully negotiate projects, licenses, and transactions with pharmaceutical counterparties.

A cancer diagnostic solutions company in the U.S. is looking for a Senior Vice President Medical. This role will be responsible for all aspects of the company’s medical and clinical strategy and implementation of that strategy for products and services. The SVP Medical will lead and manage the Clinical Operations team in Research & Development. A key role will be to partner with multiple functions and to create the strategies for the clinical trials portfolio. This individual will drive project excellence and ensure that cost, quality, and timeliness of programs align with corporate plans and established goals, striving for continuous improvement and operational efficiency.

  • M.D. required.
  • At least 10+ plus years in clinical development, including direct experience managing, planning, organizing, implementing, and completing clinical trials supporting product registration.
  • Clinical experience in diagnostic products preferred.
  • Strong working knowledge of the FDA and other regulatory organizations.
  • Ability and desire to work collaboratively with senior scientific and business leaders to execute near- and long-term plans and to adapt to rapidly changing business conditions.
  • Ability to manage multiple clinical trials at different stages in several programs as required.

A specialty pharmaceutical company is seeking a highly motivated individual to join them as Head of CMC.  The role will report directly to the Chief Medical Officer and will be the strategic and technical lead for all small molecule pharmaceutical development related activities, including drug substance process development and manufacturing, drug product formulation development and manufacturing, analytical development and quality control, supply of clinical trial materials and logistics, and support of regulatory CMC.

  • The position requires a degree in Chemistry, Pharmaceutical Science, Chemical Engineering, or related field and a minimum fifteen years of small molecule CMC development experience in a pharmaceutical or biotechnology CMC/cGMP environment. Advanced degree preferred.
  • Substantial experience implementing technical, strategic, and operational plans with projects in clinical development, e.g. Phase 1 through Phase 3 and commercialization and solid understanding of all facets and phases of CMC drug development.
  • Experience overseeing Contract Manufacturing and Contract Development Organizations, including project management and providing technical solutions, is required.
  • Demonstrated understanding of research, technical development, GMP Manufacturing, Quality, Supply Chain, Regulatory, Clinical, and Product Strategy functions and the interdependencies of those functions.
  • Experience managing a team and a proven track record of moving drug candidates from early phase development to commercial launches is required.

This position will be responsible for leading and managing all of the company’s QA programs, activities, and staff to ensure compliance with global regulations. This role will provide strategic, tactical, and technical/operational guidance regarding GxP (GMP, GLP, GCP) compliance with current pharmaceutical laws and regulations. The incumbent will report directly to the Chief Compliance Officer to plan and coordinate all necessary QA activities. She/He will be responsible for providing compliance oversight of all contractors/manufacturers and will have the ultimate authority for disposition of commercial products.

  • Bachelor’s Degree in a life science-related discipline required.
  • Advanced degree (PharmD or PhD) preferred.
  • Certified Auditor.
  • 20+ years of experience in the pharmaceutical/biotechnology industry.
  • Minimum 15 years’ senior quality systems leadership in the pharmaceutical industry.
  • High level of familiarity with a broad range of compliance areas and ability to assess risk and develop solutions.
  • Ability to build and manage relationships with business partners.
  • Strong, proven, hands-on experience with a variety of both GMP and GCP compliance matters and contractor management in the bio/pharma industry.
  • Previous experience with building QA systems and company-wide SOP system.
  • Extensive experience handling FDA inspections required.
  • Proven ability to interpret regulations and to define and communicate strategy/plan to teams across multiple programs.
  • Experience with multiple aspects of product development (CMC, nonclinical and clinical).
  • Strong knowledge of US and other major global (ICH, EU, Asian) regulatory compliance requirements.

This position will be responsible for leading and managing all of the company’s QA programs, activities, and staff to ensure compliance with global regulations. This role will provide strategic, tactical, and technical/operational guidance regarding GxP (GMP, GLP, GCP) compliance with current pharmaceutical laws and regulations. The incumbent will report directly to the Chief Compliance Officer to plan and coordinate all necessary QA activities. She/He will be responsible for providing compliance oversight of all contractors/manufacturers and will have the ultimate authority for disposition of commercial products.

  • Bachelor’s Degree in a life science-related discipline required.
  • Advanced degree (PharmD or PhD) preferred.
  • Certified Auditor.
  • 20+ years of experience in the pharmaceutical/biotechnology industry.
  • Minimum 15 years’ senior quality systems leadership in the pharmaceutical industry.
  • High level of familiarity with a broad range of compliance areas and ability to assess risk and develop solutions.
  • Ability to build and manage relationships with business partners.
  • Strong, proven, hands-on experience with a variety of both GMP and GCP compliance matters and contractor management in the bio/pharma industry.
  • Previous experience with building QA systems and company-wide SOP system.
  • Extensive experience handling FDA inspections required.
  • Proven ability to interpret regulations and to define and communicate strategy/plan to teams across multiple programs.
  • Experience with multiple aspects of product development (CMC, nonclinical and clinical).
  • Strong knowledge of US and other major global (ICH, EU, Asian) regulatory compliance requirements.

This position requires in-depth subject matter expertise, strong operational strategic thinking, and leadership skills to effectively manage safety and global pharmacovigilance resulting in regulatory controlled deliverables to both internal and external partners. This includes knowledge of global regulatory requirements for adverse event reporting during clinical development and post-marketing, and relevant experience in medical review, signal detection, risk management, and benefit-risk assessment in the context of aggregate reports (PBRER, DSUR, etc.). Additional areas of expertise: authoring experience for risk management plans, DSURs and PSURs in PBRER format/PADERs; safety input/review of clinical protocols, CSR, ICSFs, IBs; Regulatory Authority inspection experience, IND, NDA.

  • Medical degree (e.g. MD, MBBS).
  • Minimum of 10 – 18 years of experience in a relevant clinical environment.
  • High level of medical competence, with an ability to balance this with industry standards to achieve business goals.
  • A thorough knowledge of the pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities.
  • Able to work across therapeutic areas and functions.
  • Works collaboratively (establishes shared purpose across boundaries).

Our client is focused on developing the next generation of immuno-oncology therapeutics. The successful candidate will play a pivotal role in the company’s research and development activities in the area of tumor immunology, including discovery and validation of therapeutic cancer targets using cell-based assays and preclinical cancer models, and pre-clinical development of lead candidates towards IND filing and clinical development.

  • PhD scientist with a minimum of at least 7 -10 years of post-doctoral positions in academia or industry, with at least 3 years’ experience in the field of immuno-oncology.
  • Strong working knowledge of cellular and molecular immunology as it applies to cancer.
  • Ability to characterize primary immune cells from murine and human tissues and blood.
  • Expertise in the development of in vitro assays of immune/inflammatory cell differentiation, activation, and function.
  • Expertise in flow cytometry methods, analysis, and interpretation of results.
  • Expertise in conducting relevant in vitro studies and in supporting the conduct of in vivo pharmacology studies.
  • Demonstrated ability to work with outside contract research organizations or in collaboration with academic laboratories.
  • Experience in drug discovery and development in industry preferable.
  • Working knowledge and experience of regulatory/guidance requirements (i.e. GLP, FDA and EMA IND/IMPD requirements) for moving development candidates into clinical development is required.

Our client is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. The company is pioneering a new class of immunotherapies based on their proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. The lead candidate is a T cell-activating immunotherapy that combines the utility of the platform with a target. The client is currently assessing this therapy in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies.

  • Advanced degree (MD, PhD, PharmD) with 12 to 15 years of experience in Medical Affairs and unique knowledge of successful program development and execution.
  • Must have oncology experience; immuno-oncology experience strongly preferred.
  • Solid understanding of the regulations which govern Medical Affairs activities as well as detailed knowledge of common local medical practices and treatment habits.
  • Strong written and verbal communication skills with collaborative approach and ability to educate.
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THESE ARE ONLY OUR FEATURED CAREERS

CONTACT ASHTON TWEED FOR MORE OPEN CAREER OPPORTUNITIES

Phone: (610) 725-0290
Fax: (610) 975-0291
Email: info@ashtontweed.com

Ashton Tweed, Ltd.
314 S. Henderson Rd.
Suite G370
King of Prussia, PA 19406

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