Scientific Director, Strategic Bioanalytical Assay Development

Auris Health

Auris Health

United States · Germany, NB E5L 1Y4, Canada
Posted on Friday, August 25, 2023


Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Scientific Director, Strategic Bioanalytical Assay Development. The preferred locations are Spring House, PA or Beerse, Belgium. Remote work options within North America (East Coast) or Europe may be considered on a case-by-case basis and if approved by the company.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.

The Scientific Director, Strategic Bioanalytical Assay Development, for the External Sourcing and Pipeline Management group within the Bioanalytical Discovery and Development Sciences (BDDS) organization, will lead a team of scientists responsible for strategic bioanalytical assay development to support Janssen’s development portfolio (all therapeutic areas). The BDDS organization develops, validates, and conducts bioanalytical sample analysis across the entire therapeutic portfolio (all modalities) from discovery through development. We are looking for an accomplished and dedicated leader to further strengthen our bioanalytical support of the development portfolio. The Scientific Director will partner with the head of the group to reshape existing teams and establish a team of scientists that will be the BDDS single point of contact for all Janssen internal partners that are accountable for delivering on the portfolio. This individual will demonstrate strong leadership skills to influence the design of clinical plans. Recommend bioanalytical strategies that drive informed and earlier program decisions.

The Scientific Director will be responsible for ensuring bioanalytical assay readiness and timely data delivery for all assets whether they were discovered internally or acquired through deals. Through collaboration with BDDS discovery facing representatives, ensure alignment of the bioanalytical strategy and available assays based on project-specific requirements. This leader will partner closely with the leader of the Bioanalytical Outsourcing and Vendor Management team for the oversight of externalized work as well as the leader of the BDDS business management team to leverage enterprise portfolio tools for planning across the portfolio.

The Scientific Director will demonstrate expertise across a broad range of bioanalytical techniques that includes LC/MS, LBA, molecular PCR (qPCR), and cell-based assays and be required to stay on top of regulatory guidelines related to method validations and sample analyses to meet global health authority filing requirements. This leader will also be accountable for bioanalytical content included in submission documents, responses to bioanalytical regulatory questions, and ensuring BDDS representation at asset review meetings. This role will require international travel to North America and Europe.

The Scientific Director will have direct reports in Spring House, PA and Beerse, Belgium and will support the development all employees within their group as well as the broader team. This leader will be a role model of the company’s dedication to equal employment opportunity and the value of a diverse workforce.

Key Responsibilities:

  • Build and lead a diverse and complementary team of scientists.
  • Proactive plan and prioritize work to support key portfolio targets.
  • Provide scientific mentorship and coaching to staff responsible for bioanalytical portfolio management.
  • Leverage internal and external expertise to drive innovation and ensure high quality data and timely delivery.
  • Collaborate with partners responsible for assay development and validation to ensure assay availability prior to study start.
  • Serve as the BDDS representative at internal asset review forums.
  • Provide leadership towards strengthening the partnership between BDDS and our clinical colleagues.
  • Adapt quickly to transforming needs of the portfolio and work across functions in BDDS, Clinical, Regulatory Affairs, and the Quality Organization.
  • Deliver efficiently under pressure to meet deadlines.
  • Influence the design of the clinical plans to ensure bioanalytical work is value added.
  • Implement bioanalytical strategies that drive earlier and informed program decisions.
  • Collaborate effectively across organizational lines.
  • Communicate issues by highlighting risks and providing mitigation strategies.
  • Exhibit strong technical writing skills.
  • Contribute to strategic and long-range planning for BDDS and staff development/needs.


  • A minimum of a Bachelor’s degree in Chemistry, Biochemistry, Biology, or a related scientific field is required. Advanced degree (Master’s, Ph.D.) in a scientific field is preferred.
  • A minimum of 15 years of pharmaceutical industry or contract research organization (CRO) experience with a Bachelor’s degree; a minimum of 12 years of pharmaceutical industry or contract research organization (CRO) experience with a Master’s degree; or a minimum of 9 years of pharmaceutical industry or contract research organization (CRO) experience with a Ph.D. degree is required.
  • Prior managerial experience with 3+ direct reports in a pharmaceutical or CRO bioanalytical group is required.
  • Prior direct hands-on experience developing and implementing bioanalytical assays is required.
  • Experience leading cross-functional teams with a track record of developing and implementing strategies to mitigate problems is required.
  • GxP experience is highly preferred.
  • Expertise in relevant bioanalytical regulatory guidelines is required.
  • Knowledge of overall drug discovery and development is required.
  • Project management experience is required.
  • Must have excellent oral and written communication skills.
  • Must have strong organizational and process leadership skills.
  • Must have strong negotiation skills.
  • The ability to collaborate with all levels and influence decision-making across a organization is required.
  • This position will require up to 25% domestic and international travel.

The anticipated base pay range for this position in the San Francisco Bay Area, CA is $193,000 to $312,110.

The anticipated base pay range for this position in all other US locations is $157,000 to $271,400.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

  • Vacation - up to 120 hours per calendar year
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays - up to 13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

* The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.