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CAREER OPPORTUNITIES

An immuno-oncology company is looking for a Chief Development Officer (CDO). Reporting to the CEO, the CDO will be responsible for implementing the company’s strategic research and development (R&D) roadmap in support of the company’s short term and long-term growth. S/he will utilize her/his scientific expertise, networking skills and business acumen to build a competitive product pipeline and rapidly advance innovative and differentiated products based on the company’s proprietary self-delivering RNAi technology – through discovery research, pre-clinical, clinical research and strategic partnerships – in order to bring products to market in compliance with regulatory, scientific and legislative standards.

  • MD/PhD or PhD in Biology, Biochemistry, Molecular Biology or a related discipline, with at least 12 years of industry experience in pharma / biotech companies, including at least 4 years in small to midsize companies.
  • Excellent science and business know-how, as well as the proven ability to align company functions with its mission and vision.
  • Demonstrated experience in translating business/competitive know-how and scientific expertise into successful Product Development programs, leading to shareholder value.
  • Proven expertise in building and managing diverse teams (with internal and external stakeholders) and aligning various R&D, logistical and regulatory requirements resulting in product approvals within strict budget, scope and schedule boundaries.
  • Inspiring leader with superior communication skills (both verbal and written) that can thrive in a small but dynamic team environment.
  • Track record of successful collaborations with European companies and academic R&D institutions is a plus.

A publicly traded specialty global pharmaceutical company is seeking a Chief Medical Officer. Reporting to the Chief Executive Officer, this newly created position, provides the right “hands on” leader an opportunity to build a best in class clinical and medical function while making a significant impact on the future of the Company. The CMO’s principle job responsibility is the oversight and management of all clinical and medical related responsibilities including the New Drug Application (NDA) and associated clinical program for the Company’s phase III development asset.

  • Minimum of 15 years of experience in a medical affairs organization.
  • M.D. is required.
  • Extensive clinical research experience, specifically conducting clinical trials and leading the execution of pivotal phase III trials and associated strategy.
  • Experience and understanding of FDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area.
  • Experience working with the FDA on the special protocol assessment process (SPA).
  • Experience with clinical and NDA development experience with orphan drugs and securing orphan drug designation.
  • Experience with SLEEP or Central Nervous System (CNS) is preferred but not required.
  • Therapeutic Area Expertise including standards of care, current medical options for diagnosis and treatment of relevant conditions based upon franchise and pipeline products.
  • A hands on-leader who is willing to be both a leader and a doer. Experience working with smaller teams and finite resources cross-functionally across the entire Company.
  • Understanding of Medical Affairs activities and experience leading Medical Affairs function.

A clinical-stage biopharmaceutical company focused on targeted treatments for cancer is in need of a Chief Financial Officer (CFO). Utilizing a broad set of skills, the CFO will serve as a strategic partner and financial advisor to the Chief Executive Officer, other members of the senior management team and the Board of Directors to help craft the overall direction of the company. The CFO is responsible for the company’s balance sheet, capital structure, financial reporting, compliance, and risk management. The CFO will ensure that assigned functions (accounting, analysis and planning, audit, control, tax, technology, treasury, and corporate communications), have the resources and expertise to perform at a high level and meet the company’s growing needs. The CFO will work to enhance the finance function to support the business of today, while creating a finance organization and administrative capabilities that can scale as the business grows.

  • An undergraduate degree is required, preferably in accounting, finance, or a scientific field. An MBA or other advanced degree and/or CPA is preferable, but not required.
  • A strong professional reputation with at least 15 years’ experience in accounting and/or finance, with at least 5 years with a publicly traded pharmaceutical/biotechnology company.
  • Experience serving as the CFO of a publicly-traded company is preferred.
  • Experience providing Human Resource function oversight a plus.
  • Hands on experience with public company reporting, SEC regulatory issues and NASDAQ listing requirements.
  • Current knowledge of accounting, SEC and corporate governance issues and regulations.
  • The company is headquartered in North Jersey.

Our client, an early stage biopharmaceutical company discovering, developing and commercializing drugs containing cannabinoids, is in need of an interim Chief Financial Officer to work 3 – 5 days per week.  This is an interim-to-hire position for the right candidate. This position will be based in Langhorne, PA., and will report to the CEO located in CA.

  • Has been CFO in a publicly traded company within the last 5 years.
  • Has helped a public company raise money on the public markets.
  • Strong GAAP knowledge.
  • Experience with SEC filings.
  • Bachelor’s Degree in accounting.
  • Advanced Degree and/or CPA highly preferred.
  • Minimum of 10 years of strategic financial experience is required.
  • Minimum of 5 years of progressive management experience.
  • Recent experience in the Life Sciences required.

A biopharmaceutical company developing phospholipid drug conjugates (PDCs) is looking for a Vice President Medical to join their team. The ideal candidate will have a mastery of the drug development process (especially early development, PK, DMPK, ADME, and 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 role will oversee the design and implementation of early stage pre-clinical and clinical projects. He/she will ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous.

  • Highly independent role; able to make decisions with minimal consultation.
  • M.D. with drug development experience is required.
  • Clinical or research experience (in a pharmaceutical or CRO environment) related to the design and/or conduct of clinical studies in oncology and/or hematology is required.
  • Chemotherapeutic/cytotoxin experience is preferred.
  • Experience and desire with driving patient recruitment a must.
  • Ability to travel 25-30%.

A rare disease company is looking for a Regulatory Affairs Leader to lead and manage the regulatory functions and activities related to new and existing products, on a domestic and/or international basis as required by the Company and its affiliates. Ensures the implementation of the registration strategies for the Company, in line with business objectives and priorities and in compliance with regulatory requirements. Supports efforts to obtain world-wide approvals to market our products. Operates as a key stakeholder in the Company’s regulatory activities and initiatives accountable to ensure the quality of the Company’s records, products and processes. Participates as a key member of project teams responsible for lifecycle management and pipeline development programs.

  • Bachelor’s degree or equivalent required; advanced degree in the life sciences strongly preferred.
  • Must have at least ten (10) years of experience in Regulatory Affairs, with at least two (2) years of experience working with Regulatory strategy.
  • Demonstrated experience and expertise in preparing complex regulatory documents including INDs, milestone briefing packages (EOP2, EOP3, pre-NDA, Scientific Advice), NDAs, and other major regulatory submissions.
  • Experience in a commercial-stage organization required.
  • Prior experience with outsourced functions and managing contract employees preferred.
  • Demonstrated ability to deliver quality results within a fast-paced, dynamic environment.
  • This position is based in Lebanon, NJ.
  • Limited travel; approximately 20% on average; depending on business need.

An early stage biopharmaceutical company discovering, developing and commercializing drugs containing cannabinoids is looking for a Senior Finance Manager who will be responsible for overseeing the day to day finance and accounting activities including accounts payable, accounts receivable, SEC reporting, cash flow recap and various HR functions. This role will report directly to the CFO and will be based in Langhorne, PA.

  • Bachelor’s Degree in accounting.
  • Advanced Degree and/or CPA highly preferred.
  • Strong finance/accounting background with at least 5 years in a public company.
  • Recent experience in the Life Sciences preferred.
  • Experienced in QuickBooks and Microsoft Office Suite of products.
  • Ability to think critically and work well in a start-up environment.
  • Excellent verbal and written communication skills.

A clinical-stage rare disease biopharmaceutical company is looking for a Therapeutic Team Lead who will be responsible for the ‘hands on’ development and implementation of clinical development activities. Reporting to the COO, the Team Lead will provide leadership and policy direction to ensure the company meets and/or exceeds organizational goals. The successful candidate will provide strategic and tactical oversight, medical input, advice and key opinion leader interaction, concerning: Project planning for clinical trials and development programs, protocol development and review and medical review of ongoing trials. Requirements include a demonstrated understanding of, and the ability to interpret, GCP/FDA standards/guidelines, as well as a clear understanding of internal/external resource management. The selected candidate will possess a strong desire to work in an innovative, emerging growth company environment.

  • Ideal candidate will have an M.D., Ph.D., M.S., PharmD and/or MBA.
  • 7+ years of pharmaceutical/biotech experience in clinical drug development, including direct experience managing, planning, organizing, implementing, and completing clinical trials supporting product registration.
  • Clinical experience in rare diseases or therapeutic areas of interest preferred.
  • Strong working knowledge of the FDA and other regulatory organizations.
  • Strong working knowledge of GCPs, principles of ICH GCP, roles of the IRB/IEC sponsor/investigator, preparation of the clinical trial protocol, IB and clinical modules for FDA regulatory approvals.
  • Ability and desire to work collaboratively with senior scientific and business leaders to execute on 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.
  • Experience in preparing and reviewing documents for clinical development, including the coordination, review and sign-off processes to ensure high-quality document submissions to IRBs, health authorities and regulators.

A global specialty pharmaceutical company is looking for an interim professional to support commercialization of their generic product(s). This a relatively small part of the client’s business that they’d like to expand. The ideal candidate will lock in initial contacts and support initial bids with wholesalers. This Interim will manage existing customers (price, orders, etc.), develop and implement strategies to expand customer basis, and lead price and agreement negotiations. This role is also responsible for long- and short-term revenue forecasts, supporting profitability/pricing and financial analysis, and attending main trade and customers’ events.

  • Extensive experience with commercialization of generic products (U.S.).
  • Excellent knowledge of U.S. generic market (Wholesalers, GPOs, PBM, etc.).
  • Good commercial network (Customers and Payors).
  • Ability to work autonomously.
  • Knowledge of financial analysis.
  • Ability to work and interact with CFO and CEO.
  • 40 hours/week, can be remotely based. Some travel required.

A life sciences company with over 35 years of active pharmaceutical ingredient development and manufacturing expertise is looking for a Region Head/Senior Director of Business Development, responsible for driving profitable sales growth within the client’s manufacturing network. This leadership position will manage a team of five to six business development professionals across multiple disciplines in contract development and manufacturing of drug substances and drug products. This is a key management role with direct reports, but a successful candidate must be able to be a “working manager” capable of handling complex contract negotiations and managing products and accounts throughout the life cycle to ensure profitability as well as strong top line growth.

  • 15+ years of related experience and at least 5 years in a CDMO environment required.
  • Financially capable of understanding price and cost drivers and manipulation thereof to win profitable business.
  • Basic understanding of the small molecule drug development life cycle and regulatory environment from NCE’s (PI-Commercial) to generics.
  • Basic understanding of the pharmaceutical supply chain (commercial).

A life sciences company with over 35 years of active pharmaceutical ingredient development and manufacturing expertise is looking for a Director, Business Development. This role reports to the VP, Sales & Business Development and is responsible for sales growth of custom development in the assigned territory by targeting new and existing customers to secure contract manufacturing opportunities, contributing new business development opportunities from customer interactions to the portfolio development team. He/She will develop and maintain customer relationships to ensure a good network to provide the basis for future contract manufacturing agreements. The position will be the main customer interface at assigned accounts and will be responsible for communication between customer and the technical teams at our manufacturing sites. The role is also responsible for preparing proposals in response to customer RFPs by coordinating the necessary input like costs calculations and timelines from site functions.

  • Degree in Chemistry, Pharmacy or Business Administration.
  • 15-20 years of experience in sales and business development or key account management in the custom manufacturing (CMO) market.
  • Proven network in the relevant territory; preferable contacts to the sourcing organization of the top 50 pharma companies.
  • Extensive experience in all aspects of Supplier Relationship Management.
  • Experience with retaining and growing existing customer relationships and closing new accounts.
  • Strong understanding of customer and market dynamics and requirements.
  • Willingness to travel and work in a global team of professionals.

A life sciences company with over 35 years of active pharmaceutical ingredient development and manufacturing expertise is looking for a Director, Business Development, who will report to the Regional Team Leader. This role is responsible for sales growth of custom development in the assigned territory by targeting new and existing customers to secure contract manufacturing opportunities, contributing new business development opportunities from customer interactions to the portfolio development team. He/She will develop and maintain customer relationships to ensure a good network to provide the basis for future contract manufacturing agreements. He/she will be the main customer interface at assigned accounts and will be responsible for communication between customer and the technical teams at our manufacturing sites. He/she will also be responsible for preparing proposals in response to customer RFPs by coordinating the necessary input like costs calculations and timelines from site functions.

  • Degree in Chemistry, Pharmacy, or Business Administration.
  • 15-20 years of experience in sales and business development or key account management in the custom manufacturing (CMO) market.
  • Proven network in the relevant territory; preferable contacts to the sourcing organization of the top 50 pharma companies.
  • Extensive experience in all aspects of Supplier Relationship Management.
  • Experience with retaining and growing existing customer relationships and closing new accounts.
  • Strong understanding of customer and market dynamics and requirements.
  • Willingness to travel and work in a global team of professionals.

Reporting to the Chief Medical Officer, the Medical Director will be responsible for the ‘hands on’ development and implementation of clinical development activities. The Medical Director will provide leadership and policy direction to ensure the client meets and/or exceeds organizational goals. The successful candidate will provide strategic and tactical oversight, medical input, advice and key opinion leader interaction, concerning: Project planning for clinical trials and development programs, protocol development and review and medical review of ongoing trials.

  • Requirements include a demonstrated understanding of, and the ability to interpret, GCP/FDA standards/guidelines, as well as a clear understanding of internal/external resource management. The selected candidate will possess a strong desire to work in an innovative, emerging growth company environment.
  • M.D. Board certified with relevant clinical experience in areas related to client programs.
  • 7+ plus years of pharmaceutical/biotech experience in clinical drug development, including direct experience managing, planning, organizing, implementing, and completing clinical trials supporting product registration.
  • Clinical experience in rare diseases or therapeutic areas of interest preferred.

A global leader in the plasma protein biotherapeutics industry is looking for a Principal Medical Writer. This is a key leadership position responsible for determining and driving the medical writing strategy for one or more therapeutic areas within Clinical Development. As a strategic partner to senior clinical leadership, the incumbent is accountable for the efficient preparation of high quality, strategically aligned medical writing deliverables that support the clinical development, clinical safety and regulatory requirements of a clinical program. He or she is also responsible for the messaging strategy across a program of work, for the provision of strategic input into the development of clinical development plans and submission plans, and for analyzing proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (i.e., regulatory authority) in a compelling fashion with accuracy and consistency. This role has global responsibilities with potential for global reports, participation in global teams and interaction with regulatory agencies in multiple regions.

  • Post-graduate qualifications (Ph.D. or M.D. preferred).
  • A minimum of 8 years medical writing experience within the biopharmaceutical industry or a contract research organisation.
  • A minimum of 3 years in a supervisory role.
  • A comprehensive understanding of the clinical development process, including the documents that are required at each stage.
  • A comprehensive understanding of medical writing processes, standards and issues.
  • Submissions in Common Technical Document (CTD) format.
  • Knowledge of eTechnology related to regulatory submission activities (eCTD, EDMS, Life Cycle Management).

A global leader in the plasma protein biotherapeutics industry is looking for two Senior Medical Writers to lead the Medical Writing and Disclosure contributions to assigned clinical program(s). These roles are responsible for driving and developing the messaging strategy within the therapeutic area to ensure effective communication (i.e. CDP, submissions, briefing books, risk management plans, responses to HA questions) underpins successful clinical development. He or she will be required to critique ability of product strategy (e.g., submission plans) to deliver on business objectives or meet regulatory needs, and identify where new, additional or alternative arguments are needed. These roles will align, coordinate and build consistent information and messages across all individual documents within a clinical program, starting with initial strategic plans, continuing through study level documents to final program level deliverables (i.e., regulatory submission or publication of key journal articles for a publication plan).

  • Bachelor’s Degree in a scientific discipline required (Ph.D. or M.D. a plus).
  • A minimum of 5 years medical writing experience within the biopharmaceutical industry or a contract research organization.
  • A solid understanding of the clinical development process, including the documents that are required at each stage.
  • Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.
  • Prior experience with submissions in Common Technical Document (CTD) format.
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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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