Fidelis BioPharm

Current Job Openings

MEDICAL SCIENCE LIAISONS
Multiple openings nationwide in oncology, virology, cardiovascular, immunology, rheumatology, CNS/neuroloscience/psychiatry, GI, nephrology, infectious disease, and women's health.
Our clients are seeking either experienced Medical Liaisons with a PharmD, PhD or MD ( and in some cases other degrees will be acceptable) or PharmD, PhD or MD candidates with strong clinical knowledge and background in the specified therapeutic area will also be accepted. These are regional, home based positions with competitive compensation, either company car or car allowance and home office setup. Our clients range from small biotechs to the largest of big pharma.
View >>

CLINICAL RESEARCH ASSOCIATE-Dallas, TX
Looking for a Clinical Research Associate to assume monitoring responsibilities of clinical trial sites, and to develop study monitoring procedures and study management tools.

Main duties and responsibilities:
1. Manage study start-up activities (input in protocol development, development of Informed Consent Forms, Case Report Forms, and related study material)
2. Develop and implement innovative approaches for site recruitment, selection and initiation activities.
3. Conduct periodic clinical site monitoring visits to ensure the integrity of clinical data and to ensure proper storage, dispensation and accountability of clinical trial materials, according to applicable regulatory, protocol, and company guidelines
4. Maintain patient tracking records for assigned sites and/or studies.
5. Conduct study close-out visits.
6. Help prepare final study reports and compile submissions to Regulatory Authorities.

Qualifications:
BA/BS or MS in Biological Sciences, RN or health related field, and a minimum of 1-5 years of monitoring experience.
Experience in oncology trials preferred.
View >>

MEDICAL DIRECTOR-NEUROSCIENCE
This position (as GPST/GPT Leader) leads the development of the all components of the integrated development strategy and the resultant tactical clinical plan and study designs to support the global development of and establish the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of multiple compounds. This position has the overall responsibility for the scientific design, data interpretation and reporting of Phase I-IV clinical trials for the assigned compounds. Acts as the medical monitor for the clinical studies.

Accountabilities:

  • Accountable for a large-scale highly complex program including multiple indications or multiple programs.
  • Global Cross-Functional Development Program Role i.e., GPST (US, EU), or GPT (US, EU, Japan): GPST/GPT Leader. Leads team by providing overall direction and scientific expertise, and by managing results from ongoing internal studies and external research to optimize the development strategy and the resultant tactical clinical plans required to support global development of the assigned compounds in THE COMPANY development portfolio to obtain successful regulatory filing (e.g. CTD), successful commercial launch and life cycle management.
  • Feasibility Assessment: Lead the creation of the product development plan, including the design of all the clinical studies. Establishes, through the development plan, the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of candidate compound. Lead the recruitment of and communication with clinical opinion leaders during the plan development process.
  • Project Progress: Anticipates or Identifies project needs and maintains a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements.
  • High Impact Global Decisions: Monitors and interprets data from ongoing internal and external studies and makes GPT decisions that impacts development such as “go/no go” decisions or modification of development plan or study design that may have a significant impact on timeline or product labeling.
  • Works closely and communicates frequently with Clinical Operations and Project Management.
  • Competitive and Scientific information: TGRD Scientific Content Matter Expert.
  • Protocols and Reports: Creates protocol concept (Protocol Synopsis) and oversees full protocol writing. Responsible for overall content of clinical reports.
  • Responsible for overall content of regulatory submissions such as CTDs as the GPST/GPT leader.
  • Leads negotiations with regulatory authorities impacting the review and approval process.
  • Leads the clinical development perspective in due diligence evaluation of external compounds and other development opportunities.
  • Acts as the medical monitor for the clinical studies.

    MD or international equivalent plus 5 years pharmaceutical research experience, including at least 2 years in phases I-IV.

    Travel Requirements:
  • Access to transportation to attend various meetings held in proximity to THE COMPANY offices
  • Able to fly to various meetings at investigator, vendor or regulatory agency sites
  • Some international travel will be required
    View >>

    SR. MEDICAL WRITER
    Ensure, directly or indirectly, in writing themselves or by leading several contributors and CROs, high quality easy to read and to understand, and well prepared scientific, clinical and regulatory documents with the appropriate formats according to the goals, the audience targeted and the regulations and/or novelty of findings, increasing the intellectual property of the company. In addition, by providing the own scientific expertise that of the Medical Writing and Document Management group to Global Clinical Development, input ideas and methodologies in order to support the Department priorities.

    Major Accountabilities:
  • Write and/or critically review/edit documents for regulatory submissions (CSR, ISS, ISE, clinical summary and clinical overview)
  • Write and/or critically review/edit documents to scientific/clinical expertise (eg. Investigator's Brochure)
  • Select/coordinate and manage appropriate contributors for performing these tasks.
  • Review of study-level draft Protocols and draft SAPs ensuring all information required for the CSR, ISS, and ISE will be presented appropriately.
  • Participation in internal meeting as required (e.g. Clinical Satellite Teams or Clinical Study Teams) for Development products providing Medical Writing input for the preparation of Clinical Study Reports.
  • Collaborate cross-functionally and globally to coordinate the different experts involved into the clinical study report process and other regulatory documents, in order to facilitate inter-and intra-departmental flow of scientific/clinical information and increase the quality and the consistency of the documents.
  • Provide, maintain and develop strong scientific/clinical expertise to increase value of the company's projects.

    MS Degree required.
    View >>

    CLINICAL COMPLIANCE MANAGER
    The ideal candidate will provide oversight, maintenance, and documentation of clinical systems and processes within R&Ds Clinical Science area and for external resources conducting clinical activities. Facilitate adherence to QS and adherence to global regulatory requirements that apply to clinical trials.
    View >>

    CLINICAL PROJECT MANAGER
    The ideal candidate manages clinical project team members to appropriate and timely completion of projects; oversees project timeline development and maintenance. Internally interfaces with data management and biostatistics, field clinical monitors, medical directors, liaison with investigators and clinical site staff.

    Job Responsibilities:
  • Participates in the design and planning of clinical research projects.
  • Manages projects to achieve goals within budget and on schedule.
  • Coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives.
  • Oversees clinical monitoring from site qualification to site closure visits and assures integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents and medical records.
  • Maintains a high level of professional expertise through familiarity with clinical literature and participates in or leads clinical project team meetings.
  • Participates in process of selecting sites for clinical trials on investigational new drugs: assures patient eligibility, communicates and documents protocol violations, reviews and updates site-specific consent forms and documents site progress via standard reports.
  • May travel to field sites to supervise and coordinate clinical studies. Writes or assists with writing clinical development plans and other clinical documents.
    View >>

    ASSOC. DIRECTOR, REGULATORY AFFAIRS-PROMOTIONS/ADV
    Provides strategic regulatory advice on advertising and promotion materials and activities for assigned Cardiovascular products in accordance with business goals and objectives, FDA regulations, and company policy.
    Serves as a primary regulatory advertising and promotion reviewer for assigned products on PRCs.
    Liaison with DDMAC regarding advertising and promotion for assigned products.
    Manages DDMAC queries on assigned products.
    As active participant on Brand Teams, applies regulatory and therapeutic area knowledge to Brand Teams objectives and initiatives to develop solutions to complex US promotional issues.
    Ensures regulatory compliance while effectively managing business risks.
    Understands global promotional strategies and provides solutions to local US regulatory promotional issues.
    Maintains awareness of competitor activities by monitoring major US Medical meetings where assigned therapeutic area products are promoted.
    Prepares complaint letters to DDMAC.
    Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by DDMAC, and by attendance of major FDLI, DIA, and other industry/FDA meetings.
    Establishes strong and positive working relationship with DDMAC reviewers.
    Works with DRA PTR on IPT to insure that regulatory strategy will result in commercially viable US labeling on which future promotion and advertising will be based.
    Participates in US labeling negotiations and FDA meetings as necessary.
    Ensures that changes in US PI are reflected in the current promotions and advertising.

    Minimum requirements:
  • BS degree or equivalent (PhD, PharmD, or JD preferred) with a minimum of five years experience in US Drug Regulatory Affairs.
  • Excellent understanding of US regulations for drug promotions, advertising, and US labeling.
  • Strong understanding of business goals of the involved Business Franchise, marketing concepts and tools.
  • Must perform independently with strong negotiation and decision making skills.
  • Must be able to work in multi-disciplinary environment
  • Must possess strong interpersonal skills.
  • Must have analytical and problem-solving skills associated with problem reviews and inquiries
  • Must be able to provide creative solutions to complex problems
    View >>

    ASSOCIATE DIRECTOR OF REGULATORY AFFAIRS
    The Associate Director will have broad responsibilities for a variety of products, being developed for global markets. You will develop regulatory strategies, evaluate new product ideas, guide development projects, and support marketed products.

    Responsibilities include:
  • Work on IND/NDA projects, Monograph products, and novel ideas that we transform into consumer products.
  • You will be the primary contact between the FDA and Wyeth for the products/projects that you manage.
  • You will have goals that will contribute to achieving our business objectives.


    • This position requires the combination of scientific and regulatory expertise, with OTC business acumen and professionalism to meet company objectives. You will assure timely and appropriate support for obtaining and maintaining product approvals, and extending product lines. FDA and FTC requirements must be met, and the incumbent will be proactive in providing creative solutions to the exciting challenges we face.

    Additional responsibilities include:
  • Provide Regulatory guidance to the design of new product development programs.
  • Interact effectively at all levels of the organization, within Regulatory and across functions, as a persuasive advocate to achieve common goals.
  • Lead efforts to assemble and file INDs and NDAs, respond to FDA inquiries, and secure approvals.
  • Support the creation, review, approval and improvement of our labeling and advertising.
  • Keep current on OTC issues; review and assess FDA activities that affect our business.

    Qualifications:
    BS Degree; PhD preferred, JD welcomed. A minimum of 8 years of Regulatory Affairs experience, OTC experience preferred. Global experience is a plus. Strong analytical abilities coupled with creative problem solving skills. Excellent organizational and time management skills to simultaneously manage many projects. Solid collaborative, consultative and negotiating skills. Exposure to a broad R&D and/or regulatory experience; CMC, nonclinical, and clinical areas. Comfortable with minimal supervision while maintaining good communication. PC proficiency; e-NDA / CTD / e-CTD knowledge is a plus.
    View >>

    ASSOCIATE DIRECTOR OF MSLs
    The Associate Director of MSLs will be responsible for supervising field based medical and scientific activities as well as managing professional education activities in the Medical Affairs department. The candidate will direct regionally based Medical Science Liaisons (MSLs).

    Specific responsibilities include:
  • Ensuring MSLs are knowledgeable about relevant therapeutic areas and disease states (dementia, epilepsy, Parkinson's disease, acid reflux disease, thrombosis, cancer) where THE COMPANY markets products and for those in later stages of development.
  • Ensuring competency with all the company's products, including knowledge of study data.
  • Ensuring MSLs conduct themselves consistent with THE COMPANY's established principles.
  • Responsible for executing medical education activities in the Medical Affairs department, including review/approval of education programs, including CME.
    • The Associate Director will chair the Education Grants Committee, whose charter is to approve valid educational programs in compliance with current guidelines.

    Qualifications:
    M.D., PhD OR PharmD. A minimum of 6 years experience as a Medical Science Liaison or equivalent in the pharmaceutical industry. A minimum of 2 years in a supervisory role. A minimum of 4 years experience in G.I., CNS, Neurology or Cardiovascular (Thrombosis). Knowledge of roles and responsibilities of Medical Science Liaisons and strong scientific and pharmaceutical knowledge. Excellent presentation and teaching skills and knowledge of medical education activities, including CME programs and guidelines. Must have strong written and verbal skills
    View >>

    MEDICAL DIRECTOR, CLINICAL AFFAIRS
    The Medical Director, Clinical Affairs is responsible for global oversight and strategy for the clinical affairs aspects of the brand.

    Main responsibilities:
  • Liaising within the company infrastructure as well as national and international partners, to facilitate and foster scientific exchange and development within the international community.
  • Strategic planning of clinical affairs functions.
  • Work in collaboration with the life cycle team leader to develop strategic plans, in collaboration with all international partners, and in consideration of all ongoing and planned registration activities.
  • Oversee competitive intelligence efforts.
  • Continually develop relationships within therapeutic discipline.
  • Team development and ongoing training of the specialty field staff in North America.
  • Strategic planning and management of mature, dynamic, and expanding Investigator Initiated Study program.
  • Strategic planning and operational implementation of robust Publication Plan (30 publications, 15 abstracts, 5 oral presentations).
  • Primary liaison to international partners for clinical affairs functions.
  • Expert support to specialty field staff, internal infrastructure and associated vendors.
  • Primary liaison to national/international regulatory agencies for brand.
  • Liaison to international KOL, thought leaders, cooperative and working groups in HSCT Clinical oversight of pharmacokinetic program.
  • Strategic planning and operational initiation of IND programs to explore expansion of product labeling.
  • Participate, as needed, in review of new product acquisitions.

    Required Skills:
    MD, – Oncology with 2-3 yrs experience in the pharmaceutical industry or in working with clinical trials in oncology. Must have working knowledge of hematopoietic stem cell transplantation. Knowledge of US and OUS requirements for conduct of clinical trials and knowledge of ICH guidelines. Excellent oral, written communication and interpersonal skills.
    The successful candidate will also have knowledge of effective competitive strategies as well as an in-depth understanding of clinical product development in the pharmaceutical industry. High analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential. Ability to anticipate industry trends, emerging issues and competitive strategy is essential, as is the appreciation of the complexities of cross-functional management issues.
    View >>