Executive Director Clinical Research Dermatology

Job Description

The Position

Join Organon as an Executive Director, Dermatology, where you will have strategic responsibility for one or more dermatology products and may have broader responsibility for later in lifecycle therapeutic area guidance. You will be accountable for clinical strategy and support, ensuring that product-specific strategies are developed and executed in cross functional collaboration with Medical Affairs and other Development functions. You will be leading others representing the US at the Global level for a product on relevant internal committees. Further, the Executive Director drives overall product insights, including support of clinical development activities, Adverse Event (AE) evaluation for trends, advisory boards, and communication with cross-functional partners. This is a critical role within the Late-Stage Clinical Development organization that reports to the head of Late-Stage Clinical Development. This role is based in Switzerland or the US.

Responsibilities

• Develop clinical strategy for dermatologic development assets. This includes product level strategic responsibility for tapinarof, may have broader responsibility later in lifecycle development or therapeutic area.

• Provide strategic oversight and input into the near-term and long-term direction for tapinarof. Including: oversee 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, monitoring for ongoing studies, review of required regulatory submissions for medical accuracy (e.g., PADERs, DSURs, IB updates, etc.), support of global alliances/registration/development activities.

• Oversee 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 subject matter expert with regard to the science in the field of dermatology, the competitive landscape in research, and the current state of treatment in dermatologic areas of unmet medical need.

• Identify, engage and liaise with investigators and key opinion leaders regarding program strategy and scientific advice.

Lead/Co-Develop/ with responsible functions

• Accountable for the development and ongoing updates for tapinarof medical strategies, in partnership with responsible functions, and in alignment with the commercial brand strategy and global product teams.

• Develop long-term lifecycle management strategy and tactics.

• Collaborate with Medical Affairs to develop and maintain insights into the dermatologic medical landscape and to inform strategy with regard to tapinarof specifically, and dermatology in general.

Team Management

Manage a small team of clinicians, to effectively develop and execute tapinarof strategy, including delegation of responsibilities, providing ongoing oversight and coaching to ensure the team is achieving the objectives of the product strategy (as applicable).

• Serve as the in-house medical and scientific subject matter expert for tapinarof/dermatologic therapies.

• Generate Insights Develop and execute product support and long-term strategy, which may be done in partnership with other functions including Medical Affairs.

• Understand and Communicate Insights: Synthesize summarized insights and implications from relevant sources (e.g. literature, clinical results, ad boards, field medical, etc.) for cross-functional stakeholders and update product strategy (as appropriate).

External Engagement

• Develop external clinical site plan to ensure support for tapinarof is maintained at a development level, and insights into product performance are integrated into current and long-term product objectives.

• As a subject matter expert, represent the company and product as appropriate at both internal and external meetings, conferences, professional associations, publications, and communications.

Budget Management

• Accountable/Responsible for budget at the Product level, and ongoing budget management in partnership with the study team.

Execution/Content Creation

• Partner with cross-functional leads to ensure alignment related to the execution of the strategy for tapinarof and how it is pulled through into tactics (e.g., Communications, Slide Decks, Publications, Research, Protocol Development, Regulatory updates, Field Medical Support, etc.).

• Support medical review of appropriate materials as directed by XXX (e.g., Regulatory submissions, safety updates, partner (JTT) protocols/publications, etc.).

Internal Engagement

• As a dermatology subject matter leader, represent scientific views for tapinarof/dermatology (i.e., be the point of contact) on cross-functional / cross-division meetings (representation on global forums, commercial / product forums, etc.).

• Primary point of contact: Ensure oversight or appropriate delegation for dermatology/tapinarof single point of contact for Medical/Scientific questions (e.g., ensure representation to R&D, PV, Commercial Teams).

Leadership Behaviors

• Demonstrated strategic enterprise thinking, finding innovative ways to serve patients, support internal teams, and building trust, reputation, and business for the organization.

• Creates and contributes to an environment that inspires and enables people to move the product and organization forward.

• Comfortable with multi-tasking with ability to identify key issues and focus on priorities with consistent delivery of superior results.

• Executive Presence & strategic storytelling. Capable of distilling complex issues and communicating to all levels.

• 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.

Required Education, Experience and Skills

• MD or DO degree.

• Other advanced degreed professionals considered depending on past relevant biopharmaceutical industry experience, and/or clinical work, research, or academic endeavors.

• Fluent in GCP.

• Experience in dermatology and/or supporting development of dermatologic product(s).

• Demonstrated success clinical lead on a drug development project team.

• One to five years experience with clinical research, regulatory interactions, and public speaking in a biopharmaceutical organization.

• License/Certifications: Maintain minimum standards of education/certification in individual professional discipline.

Preferred Experience and Skills

• Board Certification in Dermatology.

• Deep clinical expertise and experience in late-stage drug development (Phase II-IV).

• Established track record of clinical support for regulatory submissions (e.g., IND, NDA, MAA, PIP).

Secondary Language(s) Job Description

Who We Are:

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 Womens 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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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)

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

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

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID: R533469