15 Clinical Development Director jobs in West Chester

SUMMARY/JOB PURPOSE:

In collaboration with the Exelixis clinical teams, the primary role is to lead and execute early/late stage clinical trials for oncology products in development. Participates in the design/planning of clinical studies and helps with the interpretation of study results. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May recruit clinical investigators for research studies. Responsibilities also include adverse event reporting and safety responsibilities monitoring. Coordinates and develops reporting information for reports submitted to the FDA. Monitors adherence to protocols and determines study completion.

Essential Duties And Responsibilities:

* Support the establishment of clinical trial strategies for oncology products in development.
* Design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
* Act as medical monitor for company sponsored trials.
* Support project teams with therapeutic area specific information.
* Collaborate with internal safety group in analyzing and reporting of safety data from clinical trials.
* Analyze and interpret other clinical trial data and prepare reports for regulatory agencies and publication.
* Interact with key opinion leaders and investigators in relevant disease specific area.
* Ensure consistency of scientific and development strategies for oncology products in development.
* Maintain the highest level of scientific and clinical knowledge in relevant disease specific area.

Supervisory Responsibilities:

* Supervise employees, both directly and indirectly via subordinate supervisors.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

* MD with board certification or eligibility in Oncology or Hematology/Oncology and 10 years post-residency related experience; or,
* Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

* Nine years of drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry. Note: Individuals with extensive academic experience but without experience in the pharmaceutical industry may be considered.
* Hands-on experience in the design, execution, and reporting of controlled clinical trials in oncology.
* Participated in clinical oncology studies with molecular targeted or immunological therapies.
* Understanding of basic science relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics).

Knowledge/Skills:

* Proven ability to effectively work in a cross-functional/matrix environment
* Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
* Develops technical and/or business solutions to complex problems.
* Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
* Leads or manages the work of others by providing guidance to subordinates based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
* Ability to develop and maintain relationships with significant key opinion leaders.
* Strong interpersonal, influencing, presentation, and written and verbal communication skills
* Strong organizational and time management skills

JOB COMPLEXITY:

* Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors
* Works on abstract problems across functional areas of the business
* Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
* May ensures budgets and schedules meet corporate requirements.
* Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers.

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DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

The Medical Director, Oncology Clinical Development will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The Medical Director will be responsible for clinical research activities pertaining to Medical Director, Development, Clinical, Oncology, Director, Clinical Research, Healthcare

The Medical Director, Oncology Clinical Development will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The Medical Director will be responsible for clinical research activities pertaining to advancing the development of GSK's clinical portfolio and will also have responsibility for engaging in medical dialogues with relevant scientific and medical leaders in order to lead clinical data generation activities. This individual will also have a leading role in managing effective relationships with Key External Experts.

This role requires a physician capable of developing and executing oncology clinical trials in support of the successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative and transformational Oncology agents.

Please note: This position requires an on-site office -based presence 2 to 3 days a week in the UK (London or Stevenage); Switzerland (Zug); US (Upper Providence, PA. Waltham. MA or Boston. MA); or Poland (Warsaw).

• Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute phase 1-3 interventional clinical trials
• Ensure high quality protocol development aligned with the Clinical Development Plan to effectively determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.
• Use medical expertise to contribute to the end to end (protocol concept to final study report) to ensure scientific integrity and timely delivery of clinical trials which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into decision making
• Interpret and summarize study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population.
• Assume medical responsibility for clinical trials with active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions, and addressing urgent safety questions (with inclusion of Safety/ PV as relevant).
• Assume responsibility for medical review of clinical trial data, both directly as needed and/or via oversight of delegated medical review. Oversee blinded review of data packages intended for IDMCs.
• Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies.
• Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.
• Collaborate with Principal Investigators in the evaluation and assessment of publications (abstracts, posters, manuscripts) associated with clinical data.
• Network extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of GSK's vision.
• Understand biological mechanisms, clinical strategy, scientific interpretation of disease and target-based literature.
• Serve as a core member of the Clinical Matrix Team for one or more assets in development.
• Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams.
• Participate in Oncology Clinical Development-wide initiatives and workstreams as appropriate.

• Medical degree with completion of post medical education clinical residency training
• Board/registration qualifications in medical oncology, hematology, pathology or internal medicine
• 3+ years of oncology experience in pharmaceutical/biotechnology industry and clinical practice experience in the fields noted above
• Documented academic and/or clinical research publication history or history of medical practice in the fields noted above.
• Strong working knowledge of the clinical drug development process with experience in the conduct/participation of clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications.
• Experience in regulatory requirements to support registration, including knowledge and adherence to GCP principles

• Board/registration certified or eligible physician with a PhD degree
• Experience in leading oncology clinical trials, including experience with study design, data review/interpretation and the overall clinical development process
• Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution

The Medical Director, Oncology Clinical Development will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The Medical Director will be responsible for clinical research activities pertaining to advancing the development of GSK's clinical portfolio and will also have responsibility for engaging in medical dialogues with relevant scientific and medical leaders in order to lead clinical data generation activities. This individual will also have a leading role in managing effective relationships with Key External Experts.

This role requires a physician capable of developing and executing oncology clinical trials in support of the successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative and transformational Oncology agents.

Please note: This position requires an on-site office -based presence 2 to 3 days a week in the UK (London or Stevenage); Switzerland (Zug); US (Upper Providence, PA. Waltham. MA or Boston. MA); or Poland (Warsaw).

• Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute phase 1-3 interventional clinical trials
• Ensure high quality protocol development aligned with the Clinical Development Plan to effectively determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.
• Use medical expertise to contribute to the end to end (protocol concept to final study report) to ensure scientific integrity and timely delivery of clinical trials which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into decision making
• Interpret and summarize study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population.
• Assume medical responsibility for clinical trials with active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions, and addressing urgent safety questions (with inclusion of Safety/ PV as relevant).
• Assume responsibility for medical review of clinical trial data, both directly as needed and/or via oversight of delegated medical review. Oversee blinded review of data packages intended for IDMCs.
• Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies.
• Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.
• Collaborate with Principal Investigators in the evaluation and assessment of publications (abstracts, posters, manuscripts) associated with clinical data.
• Network extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of GSK's vision.
• Understand biological mechanisms, clinical strategy, scientific interpretation of disease and target-based literature.
• Serve as a core member of the Clinical Matrix Team for one or more assets in development.
• Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams.
• Participate in Oncology Clinical Development-wide initiatives and workstreams as appropriate.

• Medical degree with completion of post medical education clinical residency training
• Board/registration qualifications in medical oncology, hematology, pathology or internal medicine
• 3+ years of oncology experience in pharmaceutical/biotechnology industry and clinical practice experience in the fields noted above
• Documented academic and/or clinical research publication history or history of medical practice in the fields noted above.
• Strong working knowledge of the clinical drug development process with experience in the conduct/participation of clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications.
• Experience in regulatory requirements to support registration, including knowledge and adherence to GCP principles

• Board/registration certified or eligible physician with a PhD degree
• Experience in leading oncology clinical trials, including experience with study design, data review/interpretation and the overall clinical development process
• Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution

Overview:

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary (Primary function)
The Senior Medical Director will be support the development and execution of the strategy and plans of one or more development program, in collaboration with the project team. The individual will be involved with the full scope of clinical drug development activities from preclinical research through Phase 4 studies. The employee will be an integral member of the project team and may serve as the clinical lead for individual asset(s) and/or provide critical and strategic input into the clinical aspects of late phase studies.

Essential Functions of the Job (Key responsibilities)

• Contribute to the development of clinical development strategy for development assets
• Lead the the scientific execution of global clinical studies, including the planning, design, implementation and execution of clinical programs and the design, preparation and initiation of study protocols.
• Have accountability for delivery of clinical study plan along with clinical operations lead that are aligned with the clinical development plan and are ethical and consistent with standard of care and local practices.
• Support data analysis and assembly, including clinical study report writing, contribution to the preparation of abstracts, presentations, and manuscripts. Interpret clinical data; research, interact with and select investigators for clinical studies and post approval support (US and globally) and supply information on resource requirements to relevant groups.
• Serve as an internal expert with regard to the science of the field, the competitive landscape in research, and the current state of treatment in areas of unmet medical need.
• Review potential in-licensing candidates and present recommendations to Senior Management groups, if requested. Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities.
• Identify, engage and liaise with investigators and key opinion leaders regarding program strategy and scientific advice.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• MD with advanced clinical training
• Minimum 5 years experience in the pharmaceutical industry or related field
• Experience includes a clinical leadership role on a drug development project team
• Demonstrated ability to work collaboratively across all levels of the organization and to lead influentially. Strong interpersonal and negotiation skills.
• Analytical and problem-solving skills; detailed oriented, an independent and critical thinker.
• Excellent communication skills and written, verbal and presentation skills.
• A credible thought leader capable of inspiring others and creating a dynamic environment that fosters innovation in thought and execution, as well as transparency.
• Experience in late-stage drug development (Phase 2, 3, and 4)
• Previous regulatory submission experience a plus (e.g., IND, NDA, MAA, PIP)
• Self-motivation and entrepreneurial spirit

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

We Respect Your Privacy

Learn more at:

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incytes data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incytes data protection officer, and your supervisory authority (if applicable).

Please contact if you have any questions or concerns or would like to exercise your rights.

Apercu Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary (Primary function) The Senior Medical Director will be support the development and execution of the strategy and plans of one or more development program, in collaboration with the project team. The individual will be involved with the full scope of clinical drug development activities from preclinical research through Phase 4 studies. The employee will be an integral member of the project team and may serve as the clinical lead for individual asset(s) and/or provide critical and strategic input into the clinical aspects of late phase studies. Essential Functions of the Job (Key responsibilities) Contribute to the development of clinical development strategy for development assets Lead the the scientific execution of global clinical studies, including the planning, design, implementation and execution of clinical programs and the design, preparation and initiation of study protocols. Have accountability for delivery of clinical study plan along with clinical operations lead that are aligned with the clinical development plan and are ethical and consistent with standard of care and local practices. Support data analysis and assembly, including clinical study report writing, contribution to the preparation of abstracts, presentations, and manuscripts. Interpret clinical data; research, interact with and select investigators for clinical studies and post approval support (US and globally) and supply information on resource requirements to relevant groups. Serve as an internal expert with regard to the science of the field, the competitive landscape in research, and the current state of treatment in areas of unmet medical need. Review potential in-licensing candidates and present recommendations to Senior Management groups, if requested. Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities. Identify, engage and liaise with investigators and key opinion leaders regarding program strategy and scientific advice. Qualifications (Minimal acceptable level of education, work experience, and competency) MD with advanced clinical training Minimum 5 years' experience in the pharmaceutical industry or related field Experience includes a clinical leadership role on a drug development project team Demonstrated ability to work collaboratively across all levels of the organization and to lead influentially. Strong interpersonal and negotiation skills. Analytical and problem-solving skills; detailed oriented, an independent and critical thinker. Excellent communication skills and written, verbal and presentation skills. A credible 'thought leader' capable of inspiring others and creating a dynamic environment that fosters innovation in thought and execution, as well as transparency. Experience in late-stage drug development (Phase 2, 3, and 4) Previous regulatory submission experience a plus (e.g., IND, NDA, MAA, PIP) Self-motivation and entrepreneurial spirit Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at: The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable). Please contact if you have any questions or concerns or would like to exercise your rights. #J-18808-Ljbffr

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary (Primary function)
The Senior Medical Director will be support the development and execution of the strategy and plans of one or more development program, in collaboration with the project team. The individual will be involved with the full scope of clinical drug development activities from preclinical research through Phase 4 studies. The employee will be an integral member of the project team and may serve as the clinical lead for individual asset(s) and/or provide critical and strategic input into the clinical aspects of late phase studies.

Essential Functions of the Job (Key responsibilities)

• Contribute to the development of clinical development strategy for development assets
• Lead the the scientific execution of global clinical studies, including the planning, design, implementation and execution of clinical programs and the design, preparation and initiation of study protocols.
• Have accountability for delivery of clinical study plan along with clinical operations lead that are aligned with the clinical development plan and are ethical and consistent with standard of care and local practices.
• Support data analysis and assembly, including clinical study report writing, contribution to the preparation of abstracts, presentations, and manuscripts. Interpret clinical data; research, interact with and select investigators for clinical studies and post approval support (US and globally) and supply information on resource requirements to relevant groups.
• Serve as an internal expert with regard to the science of the field, the competitive landscape in research, and the current state of treatment in areas of unmet medical need.
• Review potential in-licensing candidates and present recommendations to Senior Management groups, if requested. Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities.
• Identify, engage and liaise with investigators and key opinion leaders regarding program strategy and scientific advice.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• MD with advanced clinical training
• Minimum 5 years' experience in the pharmaceutical industry or related field
• Experience includes a clinical leadership role on a drug development project team
• Demonstrated ability to work collaboratively across all levels of the organization and to lead influentially. Strong interpersonal and negotiation skills.
• Analytical and problem-solving skills; detailed oriented, an independent and critical thinker.
• Excellent communication skills and written, verbal and presentation skills.
• A credible 'thought leader' capable of inspiring others and creating a dynamic environment that fosters innovation in thought and execution, as well as transparency.
• Experience in late-stage drug development (Phase 2, 3, and 4)
• Previous regulatory submission experience a plus (e.g., IND, NDA, MAA, PIP)
• Self-motivation and entrepreneurial spirit

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

We Respect Your Privacy

Learn more at:

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).

Please contact if you have any questions or concerns or would like to exercise your rights.

Overview

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

The Senior Medical Director will support the development and execution of the strategy and plans of one or more development programs, in collaboration with the project team. The individual will be involved with the full scope of clinical drug development activities from preclinical research through Phase 4 studies. The employee will be an integral member of the project team and may serve as the clinical lead for individual asset(s) and/or provide critical and strategic input into the clinical aspects of late phase studies.

• Contribute to the development of clinical development strategy for development assets.
• Lead the scientific execution of global clinical studies, including the planning, design, implementation, and execution of clinical programs and the design, preparation, and initiation of study protocols.
• Have accountability for delivery of clinical study plans along with clinical operations leads that are aligned with the clinical development plan and are ethical and consistent with standard of care and local practices.
• Support data analysis and assembly, including clinical study report writing, contribution to the preparation of abstracts, presentations, and manuscripts. Interpret clinical data; research, interact with, and select investigators for clinical studies and post-approval support (US and globally) and supply information on resource requirements to relevant groups.
• Serve as an internal expert with regard to the science of the field, the competitive landscape in research, and the current state of treatment in areas of unmet medical need.
• Review potential in-licensing candidates and present recommendations to Senior Management groups, if requested. Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities.
• Identify, engage, and liaise with investigators and key opinion leaders regarding program strategy and scientific advice.

• MD with advanced clinical training.
• Minimum 5 years experience in the pharmaceutical industry or related field.
• Experience includes a clinical leadership role on a drug development project team.
• Demonstrated ability to work collaboratively across all levels of the organization and to lead influentially. Strong interpersonal and negotiation skills.
• Analytical and problem-solving skills; detail-oriented, an independent and critical thinker.
• Excellent communication skills and written, verbal, and presentation skills.
• A credible thought leader capable of inspiring others and creating a dynamic environment that fosters innovation in thought and execution, as well as transparency.
• Experience in late-stage drug development (Phase 2, 3, and 4).
• Previous regulatory submission experience a plus (e.g., IND, NDA, MAA, PIP).
• Self-motivation and entrepreneurial spirit.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

The Product Toxicology Lead within the Non-Clinical Development Team (NCD), is responsible for providing non-clinical toxicology expertise to existing products and life-cycle management of programs in the Organon portfolio as well as supporting toxicological assessments associated with chemistry, manufacturing and control (CMC) activities. This position will report to the Executive Director, Translational Sciences and Non-Clinical Development and work collaboratively with other members within the NCD sub-function, as necessary.

The NCD team is comprised of drug development scientists representing toxicology, DMPK, and pharmacology, serving a key function within the Translational Medicine and Early Development (TMED) team. Cross-functional interactions are expected across early clinical development, late-clinical development, regulatory affairs, safety and pharmacovigilance, CMC, medical affairs, and business development.

To that aim, the Product Toxicology Lead will serve as an active member and primary nonclinical representative on asset development teams (ADTs) to support the life-cycle management as well as regulatory- and safety-driven activities for existing products in Organon's portfolio of Women's Health, General Medicines, and Biosimilars. The Product Toxicology Lead will also collaborate with CMC to assess process manufacturing impurities, degradants, and/or extraneous matters and conduct risk assessments to inform mitigation strategies in accordance with regional and/or global regulatory requirements. This position will also be responsible for contributing to and reviewing nonclinical and clinical modules for regional regulatory submissions and renewals globally and contributes to the authoring and review of briefing books and other regulatory documents, as applicable.

Responsibilities

• Serve as the Non-Clinical Lead on asset development teams (ADTs) to support the life-cycle management as well as regulatory- and safety-driven activities for existing products in Organon's portfolio of Women's Health, General Medicines, and Biosimilars.
• Non-clinical toxicology liaison with CMC and Occupational Safety to evaluate process manufacturing impurities and/or degradants and conduct risk assessments to inform mitigation strategies in accordance with regional and/or global regulatory requirements.
• Author and review of nonclinical CTD modules, briefing books, or other regulatory communications for regional regulatory submissions or renewals for global products within the Organon portfolio.

Tasks

• Provide scientific and nonclinical (toxicology, pharmacology, DMPK) input into existing products.
• Serve as non-clinical point of contact for Regulatory, Safety, and Pharmacovigilance activities support of the Organon Women's Health, General Medicines and Biosimilars product portfolio.
• Track and coordinate nonclinical development resources, in conjunction with department management, to support application of nonclinical development resources to activities across the Organon portfolio of products. May be responsible for overseeing and/or reviewing work of others.
• Prepare, contribute to and/or review the nonclinical, early clinical development or CMC documentation to support regulatory submissions to regional Health Authorities worldwide; may participate in interactions with Health Authorities.
• Support Regulatory activities for global products such as, annual reporting of nonclinical activities and literature, support new regional drug applications, regional license renewals, author or co-author responses to questions from global Heath Authorities.
• Support Drug Safety and Pharmacovigilance with activities such as review of nonclinical literature for new risks, signal evaluation for issues identified through pharmacovigilance or communications through Health Authorities, and author responses to regulatory inquiries, as appropriate.
• Contribute to regional or global product label reviews and updates, as appropriate.
• Collaborate with CMC and Occupational Safety to evaluate process manufacturing impurities and/or degradants and conduct risk assessments to inform mitigation strategies in accordance with regional and/or global regulatory requirements. Provide nonclinical development support for occupational and environmental risk assessments.
• Engage and communicate effectively with regulators, scientific leaders, and physicians, as needed.
• Support the established product portfolio in line with Good Laboratory Practices (GLP), Good Clinical Practice (GCP) and relevant Organon Standard Operating Procedures (SOPs).

Required Education, Experience and Skills

• PhD, DVM or equivalent degree in pharmacology, biology, physiology, biochemistry, chemistry, toxicology or related sciences.
• Board certification in toxicology a plus (e.g., DABT, ERT).
• A minimum of seven to ten years of experience in the pharmaceutical or biotech industry with extensive and in-depth knowledge of nonclinical development, including toxicology, DMPK and pharmacology.
• Demonstrated technical and scientific knowledge in nonclinical sciences with a particular emphasis on supporting late-stage drug development and life-cycle management.
• Demonstrated knowledge of nonclinical development as well as drug substance and drug product impurity-related regulatory guidelines and GxP requirements.
• Extensive experience with review and authoring nonclinical sections of regulatory dossiers (e.g., NDAs) and product labels with first-hand experience with agency interactions (meetings, briefing books and response documents).
• Experience in working in project teams (preferably global project teams).
• Exemplifies leadership qualities including effective communication and collaboration, integrity, and respectful interactions with Organon personnel.
• Excellent organizational and interpersonal skills.
• Ability to process and articulate complex ideas in a manner that can be clearly communicated to less technically trained individuals.
• Ability to prioritize and focus on important data and considerations to drive results and provide solution-oriented recommendations with an appropriate scientific rationale to address challenges associated with life-cycle management and CMC activities.

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

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Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.

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Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Applicable to United States Positions Only:

Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US)

$52,300.00 - 259,200.00

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1