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Senior Director, Clinical Development (Early Development)

Company: PTC Therapeutics
Location: Plainfield
Posted on: September 13, 2020

Job Description:

Senior Director, Clinical Development (Early Development) USA - New Jersey - South Plainfield

Job Description Summary: The Senior Director, Early Clinical Development provides strategic input in developing and implementing biomarker programs across different PTC Therapeutics sponsored projects, proof of concept studies and first in human investigational trials. The incumbent will work closely with the Research, Clinical Development and Clinical Operations groups to direct the translation of preclinical research into clinical applications, to develop, validate and implement biomarkers and pharmacodynamic and mechanism assays. The incumbent will have the skills associated with the development of and approvals in the companion diagnostic space. This role embraces the principles of a translational medicine mindset, with a focus on operational excellence and deep scientific rigor. The ideal candidate will have a passionate desire to help transform current treatment paradigms while working in an innovative and fast-paced environment.

The incumbent, in collaboration with the Research groups, contribute to and implements biomarker strategy for clinical studies in programs with attention to pharmacokinetics, pharmacodynamics, proof of mechanism and patient selection (companion diagnostics).. The incumbent, in collaboration with others in Clinical Development, is responsible for the biomarker aspect of clinical protocol design and writing, as well as authoring the biomarker sections of Investigator Brochures, Clinical Study Protocols and Reports, program documents, regulatory submissions and responses (INDs/CTAs) as well as co-authoring, assisting and supporting the development of publications, abstracts, and presentations

The Senior Director, Clinical Development is a key representative of PTC's clinical development organization in meetings with external stakeholders and audiences as needed; as such he/she may author or review, for quality purposes, clinical/medical-related materials intended for external audiences.

This newly developed role will be dedicated to our early stage Neurology programs with a focus on rare diseases. The incumbent will look to build bridges with research teams to deliver non-clinical package necessary to support translation into clinical programs. This role will deal with a diverse portfolio in neurology and will require a strong ability to think outside of the box. This is a non-supervisory role but will need to utilize the power of influence in progressing in working with said cross functional teams.

The incumbent works cross-functionally with internal departments and external resources on Clinical Development related issues.

The Senior Director, Early Clinical Development ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. Job Description: Contributes to PTC’s global clinical development strategy for his/her assigned indication and/or Therapeutic Area and leads the implementation of the clinical strategy.

Provides input into Research and Translation activities as well as the identification of early indications.

Provides strategic input in the design and implementation of preclinical POC and mechanism studies.

Provides strategic input in the development and monitoring of the quality of pharmacokinetic, pharmacodynamic and patient stratification biomarker assays to support the advancement of preclinical programs into the clinic.

Provides strategic input in the design and implementation of biomarker analysis in clinical trials, ensuring operational execution by partnering with biomarker labs and data management according to cGCP guidelines.

Works with a cross functional team (Clinical Leads, Medical Monitors, nonclinical and discovery Research Scientists, Regulatory, Biostatistics and Clinical Operations) to ensure early definition of, and agreement on biomarker strategy for clinical development and regulatory approvals.

Maintains up-to-date knowledge of scientific and clinical published literature in the relevant area(s).Partner with biostatisticians and biomarker laboratories to establish biomarker analysis plans to ensure delivery of high-quality data to support analysis, interpretation and reports of clinical biomarkers for internal decision-making and Health Authority submissions.

Facilitates communication and collaboration with internal, cross-functional team members including, but not limited to, research, manufacturing, drug supply, regulatory, quality assurance, marketing and external key stakeholders including, but not limited to, collaborators, KOLs, investigators and domestic and international regulatory authorities, to support CDPs, regulatory submissions and clinical development goals.

Ensures adherence to the highest scientific, ethical and regulatory standards and ensures compliance with all applicable GCP regulatory requirements

Represents PTC's Clinical Development team in meetings with external collaborators regarding the status of partnered clinical development projects

Supports the assessment of in-licensing product candidates in area of expertise, as needed.

May manage, coach and mentor direct reports.

Qualifications: Advanced degree, may include MD, Ph.D. or PharmD., and a minimum of 5 years of progressively responsible and related experience in a pharmaceutical, biotechnology or related environment.

* Special knowledge or skills needed and/or licenses or certificates required.

Experience working in rare/orphan disease clinical development.

Demonstrated hands-on experience leading a large, multi-country, clinical development program.

Demonstrated working knowledge of early- and late-phase drug development and applicable regulatory processes.

Demonstrated ability to lead/oversee clinical trial design, conduct and interpretation of clinical data.

Hands-on experience with the development of regulatory submissions.

Ability to influence without direct authority.

Proficiency with Microsoft Office.

Excellent verbal and written communication and skills.

Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Ability to travel domestically and internationally.

*Special knowledge or skills and/or licenses or certificates preferred.

CNS or metabolic development experience

Previous supervisory experience.

* Travel requirements

20 – 30 %

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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PTC is biopharmaceutical company focused on the discovery and development of orally-administered, proprietary small molecule drugs that target post-transcriptional control processes. While PTC’s discovery programs are directed at targets in multiple therapeutic areas, PTC is focusing particularly on the development and commercialization of treatments for orphan and ultra-orphan disorders. Post-transcriptional control processes regulate the rate and timing of protein production and are essential to proper cellular function. PTC’s internally-discovered pipeline addresses multiple therapeutic areas, including neuromuscular disorders, oncology and infectious diseases. For more information on the company, please visit our website www.ptcbio.com. ?

Keywords: PTC Therapeutics, Plainfield , Senior Director, Clinical Development (Early Development), Other , Plainfield, New Jersey

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